ClinicalTrials.gov Search Results 08/15/2018endals.altervista.org/downloads/AllALSTrialsUSA15Aug2018.pdfJuly 15, 2017 Primary Completion: January 31, 2020 Study Completion: July 14,

- Page 1 of 56 -

ClinicalTrials.gov Search Results 08/15/2018

NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators

FunderType

Dates Locations

1 NCT03613038 A Systematic Investigation ofPhonetic Complexity Effects onArticulatory Motor Performancein Progressive Dysarthria

Study Documents:

Title Acronym:

Other Ids:

•1209643

•1R15DC016383-01

Recruiting •AmyotrophicLateral Sclerosis

•Parkinson Disease

•Behavioral:Phoneticcomplexity effectson speech motorperformance

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Intervention Model: SingleGroup Assignment

•Masking: None (OpenLabel)

•Primary Purpose: BasicScience

Outcome Measures:

•Peak movement speed

•Range of movement

•Duration

•Spatiotemporal movementvariability (STI)

•Inter-articulatorcoordination

Enrollment:

150

Age:

19 Years to 90Years (Adult,Older Adult)

Sex:

All

•Universityof Missouri-Columbia

•National Instituteon Deafnessand OtherCommunicationDisorders(NIDCD)

•Other

•NIH

Study Start:

July 15, 2017

Primary Completion:

January 31, 2020

Study Completion:

July 14, 2020

First Posted:

August 2, 2018

Results First Posted:

No Results Posted

Last Update Posted:

August 3, 2018

•University of Kansas MedicalCenter, Fairway, Kansas,United States

•University of Missouri-Columbia, Columbia, Missouri,United States

2 NCT03519880 A Pilot Study of the Utility of 3DPrinted Masks for ALS Subjects

Study Documents:

Title Acronym:

Other Ids:

HUM00112433

Enrolling byinvitation

•AmyotrophicLateral Sclerosis

•Device: CustomMask Interface

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Primary Purpose: DeviceFeasibility

Outcome Measures:

•Average number of hoursthe custom NIV maskinterface is used per night

•Leak parameters fromdevice

•Tidal volumemeasurements

•Interviews with subjectsregarding their experiencewith the custom maskQualitative assessment ofcustom NIV mask efficacy

Enrollment:

40

Age:

18 Years and older (Adult, OlderAdult)

Sex:

All

•University ofMichigan

•ALS Association

•Other Study Start:

March 14, 2017

Primary Completion:

April 2020

Study Completion:

April 2021

First Posted:

May 9, 2018


No Results Posted

Last Update Posted:

May 9, 2018

•Michigan Medicine, Ann Arbor,Michigan, United States

https://ClinicalTrials.gov/show/NCT03613038






- Page 2 of 56 -


FunderType

Dates Locations

3 NCT03520517 Open-label Study to EvaluateSafety, Tolerability and PK ofBHV-0223 in ALS

Study Documents:

Title Acronym:

Other Ids:

BHV0223-103

Active, notrecruiting


•ALS

•Lou Gehrig Disease

•Lou Gehrig'sDisease

•Lou-GehrigsDisease

•Motor NeuronDisease,AmyotrophicLateral Sclerosis

•Drug: BHV-0223 Study Type:

Interventional

Phase:

Phase 1

Study Design:



•Primary Purpose:Treatment

Outcome Measures:

•Incidence of TreatmentEmergent Adverse Events(Safety and Tolerability)

•BHV-0223 Concentrationsin Blood at Days 1, 29 and57

Enrollment:

22

Age:


Sex:

All

•BiohavenPharmaceuticals,Inc.

•CognitiveResearchCorporation

•Industry Study Start:

February 2, 2018

Primary Completion:

October 31, 2018

Study Completion:

October 31, 2018

First Posted:

May 9, 2018


No Results Posted

Last Update Posted:

August 6, 2018

•Holy Cross NeuroscienceResearch Institute, FortLauderdale, Florida, UnitedStates

•Somnos/Neurology AssociatesClinical Research, Lincoln,Nebraska, United States

•Neurosciences Institute,Neurology - Charlotte,Charlotte, North Carolina,United States

•Wesley Neurology Clinic,Cordova, Tennessee, UnitedStates

•Texas Neurology, Dallas,Texas, United States

4 NCT03516994 Reducing Disparities in theQuality of Advance CarePlanning for Older Adults

Study Documents:

Title Acronym:

EQUALACP

Other Ids:

•Pro00091633

•OLC-1609-36381

Not yetrecruiting

•Metastatic Cancer

•Congestive HeartFailure

•Chronic ObstructivePulmonary Disease


•Interstitial LungDisease


•End Stage LiverDisease

•End Stage RenalDisease

•DiabetesComplications

•Behavioral:RespectingChoices First Steps

•Behavioral: FiveWishes Form

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: Randomized

•Intervention Model: ParallelAssignment


•Primary Purpose: Other

Outcome Measures:

•Proportion of AfricanAmericans who completeadvance care planning

•Proportion of Whites whocomplete advance careplanning

•Difference in Proportionof Whites versus AfricanAmericans who completeadvance care planning

•Patient Readiness toEngage in Advance CarePlanning

•Patient Quality of Life

Enrollment:

800

Age:

65 Years and older (Older Adult)

Sex:

All

•Duke University •Other Study Start:

August 1, 2018

Primary Completion:

September 1, 2022

Study Completion:

September 1, 2022

First Posted:

May 7, 2018


No Results Posted

Last Update Posted:

May 8, 2018

•University of Alabama atBirmingham, Birmingham,Alabama, United States

•Emory University, Atlanta,Georgia, United States

•University of South Carolina,Columbia, South Carolina,United States

•University of TexasSouthwestern, Dallas, Texas,United States







- Page 3 of 56 -


FunderType

Dates Locations

5 NCT03506425 A Pilot Trial of Triheptanoin forPeople With Amyotrophic LateralSclerosis (PALS)

Study Documents:

Title Acronym:

Other Ids:

Pro00092250

Recruiting •ALS •Drug: Triheptanoin Study Type:

Interventional

Phase:

•Phase 1

•Phase 2

Study Design:

•Allocation: Non-Randomized




Outcome Measures:

•ALSFRS-R slope ontreatment compared to pre-treatment

•Magnetic ResonanceSpectroscopy

•Oxidative Stress Markers

Enrollment:

10

Age:


Sex:

All

•Richard Bedlack,M.D., Ph.D.

•UltragenyxPharmaceuticalInc

•Duke University

•Other

•Industry

Study Start:

June 21, 2018

Primary Completion:

February 2019

Study Completion:

February 2019

First Posted:

April 24, 2018


No Results Posted

Last Update Posted:

August 13, 2018

•Duke University, Durham, NorthCarolina, United States




- Page 4 of 56 -


FunderType

Dates Locations

6 NCT03505021 Effects of Oral Levosimendan(ODM-109) on RespiratoryFunction in Patients With ALS

Study Documents:

Title Acronym:

REFALS

Other Ids:

3119002


•Drug:Levosimendan

•Drug: Placebo forlevosimendan

Study Type:

Interventional

Phase:

Phase 3

Study Design:



•Masking: Quadruple(Participant, Care Provider,Investigator, OutcomesAssessor)


Outcome Measures:

•Supine slow vital capacitySVC

•Combined assessment ofRevised ALS FunctionalRating Scale ALSFRS-R function and survivalthrough 48 weeks

•Time to respiratory eventthrough 48 weeks

•Clinical Global ImpressionCGI at 48 weeks

•Change from baselinein respiratory function ofALSFRS-R at 48 weeks

Enrollment:

450

Age:


Sex:

All

•OrionCorporation,Orion Pharma


June 21, 2018

Primary Completion:

August 30, 2020

Study Completion:

October 30, 2020

First Posted:

April 20, 2018


No Results Posted

Last Update Posted:

July 17, 2018

•Neuromuscular ResearchCenter and NeuromuscularClinic of Arizona, Phoenix,Arizona, United States

•Colorado Springs NeurologicalAssociates, Colorado Springs,Colorado, United States

•Hospital of Special Care, NewBritain, Connecticut, UnitedStates

•The George WashingtonMedical Faculty Associates -Foggy Bottom North Pavilion,Washington, District ofColumbia, United States

•Providence Holy Cross MedicalCenter, Fort Lauderdale,Florida, United States

•University of Florida Health- Jacksonville, Jacksonville,Florida, United States

•University of South Florida,Tampa, Florida, United States

•Emory University School ofMedicine, Atlanta, Georgia,United States

•University of KentuckyChandler Medical Center,Lexington, Kentucky, UnitedStates

•Massachusetts GeneralHospital, Boston,Massachusetts, United States

•and 36 more




- Page 5 of 56 -


FunderType

Dates Locations

7 NCT03488524 Open Label Extension Study ofAMX0035 in Patients With ALS

Study Documents:

Title Acronym:

CENTAUR-OLE

Other Ids:

AMX-3500-OLE


•ALS

•Drug: AMX0035 Study Type:

Interventional

Phase:

Phase 2

Study Design:




Outcome Measures:

•Quantity of adverse eventsand serious adverseevents observed in thestudy

•Hospitalizations

•Rate of Progression onthe Amyotrophic LateralSclerosis Rating ScaleRevised (ALSFRS-R)

•Rate of Progressionon ATLIS StrengthMeasurement

•Rate of Progression onSlow Vital Capacity

•Gastric Tube Frequency

•Permanent InvasiveVentilation

Enrollment:

132

Age:

Child, Adult, OlderAdult

Sex:

All

•AmylyxPharmaceuticalsInc.

•MassachusettsGeneral HospitalNeurologyClinicalResearchInstitute

•Industry

•Other

Study Start:

March 29, 2018

Primary Completion:

January 1, 2020

Study Completion:

January 1, 2020

First Posted:

April 5, 2018


No Results Posted

Last Update Posted:

April 13, 2018


•University of MassachusettsMemorial Medical Center,Worcester, Massachusetts,United States

8 NCT03489278 Clinical Procedures to SupportResearch

Study Documents:

Title Acronym:

CAPTURE

Other Ids:

•20170785

•U54NS092091


•ALS-FrontotemporalDementia

•Primary LateralSclerosis

•ProgressiveMuscular Atrophy

Study Type:

Observational

Phase:

Study Design:

•Observational Model:Cohort

•Time Perspective:Prospective

Outcome Measures:

Using the ALS Toolkitfor collecting and usingelectronic health recorddata for research purposes

Enrollment:

1200

Age:


Sex:

All

•University ofMiami

•MuscularDystrophyAssociation

•National Instituteof NeurologicalDisorders andStroke (NINDS)

•National Centerfor AdvancingTranslationalScience(NCATS)

•NationalInstitutes ofHealth (NIH)

•Other

•NIH

Study Start:

February 15, 2018

Primary Completion:

January 2021

Study Completion:

January 2021

First Posted:

April 5, 2018


No Results Posted

Last Update Posted:

April 5, 2018

•California Pacific MedicalCenter, San Francisco,California, United States

•University of Miami, Miami,Florida, United States





- Page 6 of 56 -


FunderType

Dates Locations

9 NCT03474263 IC14 for Rapidly ProgressiveAmyotrophic Lateral Sclerosis(ALS)

Study Documents:

Title Acronym:

Other Ids:

ALS02

Not yetrecruiting


•Biological: Biologic:IC14 (monoclonalantibody againsthuman CD14)

Study Type:

Interventional

Phase:

Phase 2

Study Design:




Outcome Measures:

•Glial Activation

•Serum neurofilament

•Urinary p75 neurotrophinreceptor

•Safety

•Immunogenicity

•Pharmacokinetics

•Pharmacodynamics

Enrollment:

20

Age:


Sex:

All

• ImplicitBioscience

•MassachusettsGeneral Hospital

• Industry

•Other

Study Start:

September 1, 2018

Primary Completion:

April 12, 2020

Study Completion:

July 12, 2020

First Posted:

March 22, 2018


No Results Posted

Last Update Posted:

April 18, 2018

•Neurological Clinical ResearchInstitute (NCRI), Boston,Massachusetts, United States

10 NCT03472950 Safety and Efficacy ofRanolazine for the Treatment ofAmyotrophic Lateral Sclerosis

Study Documents:

Title Acronym:

Other Ids:

STUDY00141491

Recruiting •ALS •Drug: Ranolazine500 MG

•Drug: Ranolazine1000 MG

Study Type:

Interventional

Phase:

Phase 2

Study Design:


•Intervention Model:Sequential Assignment



Outcome Measures:

•Dose limiting toxicities(DLT)

•Cramp Questionnaire

•Fasciculation frequency onmuscle ultrasound

•Cramp potential duration

Enrollment:

20

Age:


Sex:

All

•University ofKansas MedicalCenter

•Gilead Sciences

•Other

•Industry

Study Start:

June 11, 2018

Primary Completion:

June 11, 2019

Study Completion:

June 11, 2019

First Posted:

March 21, 2018


No Results Posted

Last Update Posted:

June 19, 2018

•University of Kansas MedicalCenter, Kansas City, Kansas,United States







- Page 7 of 56 -


FunderType

Dates Locations

11 NCT03464903 Study of ALS Reversals 2:Genetic Analyses

Study Documents:

Title Acronym:

StAR2

Other Ids:

•Pro00091570

•8007




Study Type:

Observational

Phase:

Study Design:

•Observational Model:Case-Control

•Time Perspective: Other

Outcome Measures:

•genetic comparison

•factors associated withgenes

Enrollment:

30

Age:


Sex:

All

•Duke University

•ClinicalResearch in ALSand RelatedDisorders forTherapeuticDevelopment(CReATe)Consortium(funded by NIH/NCATS/NINDS)


June 25, 2018

Primary Completion:

December 2018

Study Completion:

December 2018

First Posted:

March 14, 2018


No Results Posted

Last Update Posted:

July 30, 2018

•Duke ALS Clinic / DUSOMDept of Neurology / DUHS,Durham, North Carolina, UnitedStates

12 NCT03457753 Riluzole Oral Soluble FilmSafety and Tolerability inAmyotrophic Lateral Sclerosis

Study Documents:

Title Acronym:

Other Ids:

17MO1R-0016

Not yetrecruiting

•ALS •Drug: Riluzole OralSoluble Film

Study Type:

Interventional

Phase:

Phase 2

Study Design:




Outcome Measures:

Change from baseline inNCI-CTC score at week 12

Enrollment:

25

Age:


Sex:

All

•AquestiveTherapeutics

•Inventiv Health

•Covance

•Industry

•Other

Study Start:

March 2018

Primary Completion:

September 2018

Study Completion:

October 2018

First Posted:

March 8, 2018


No Results Posted

Last Update Posted:

March 21, 2018

•University of Florida MedicalCenter, Gainesville, Florida,United States

•Neurology Associates, P.C.,Lincoln, Nebraska, UnitedStates

•Texas Neurology, P.A., Dallas,Texas, United States






- Page 8 of 56 -


FunderType

Dates Locations

13 NCT03456882 The Effect of RNS60 on ALSBiomarkers

Study Documents:

Title Acronym:

RNS60

Other Ids:

RNS60


•Drug: RNS60 Study Type:

Interventional

Phase:

Phase 2

Study Design:




Outcome Measures:

•Pharmacodynamicbiomarkers

•ALSFRS-R scale

•Survival

•Forced Vital Capacity(FVC)

•Incidence of adverse event(Tolerability) related toRNS60

•Quality of life

Enrollment:

142

Age:


Sex:

All

•Mario NegriInstitute forPharmacologicalResearch

•ALS Association

•Get out ONLUS


November 18, 2016

Primary Completion:

April 30, 2019

Study Completion:

April 30, 2019

First Posted:

March 7, 2018


No Results Posted

Last Update Posted:

June 8, 2018


•Azienda OpsedalieraUniversitaria ConsorzialePoliclinico- Università deglistudi di Bari, Bari, Italy

•Spedali civili di Brescia,Brescia, Italy

•ASST Valle Olona Presidioospedaliero Gallarate,Gallarate, Italy

•IRCCS Azienda OspedalieraUniversitaria San Martino IST,Genova, Italy

•Ospedale San Raffaele, Miano,Italy

•Centro Clinico NEMO -Fondazione Serena Onlus,Milano, Italy

•Presidio OspedalieroProvinciale - Nuovo OspedaleCivile "S. Agostino Estense",Modena, Italy

•Azienda OspedalieraUniversitaria della SecondaUniv. Degli Studi di Napoli(AOU-SUN), Napoli, Italy

•Azienda OspedalieroUniversitaria Maggiore dellaCarità, Novara, Italy

•and 10 more

14 NCT03449212 SOD1 Kinetics Measurements inALS Patients

Study Documents:

Title Acronym:

Other Ids:

SOD1-001

Recruiting •AmyotrophicLateral Sclerosis,Familial

•AmyotrophicLateral Sclerosis,Sporadic

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•The primary outcomemeasurement will be thedetermination of the SOD1half-life in the CSF of eachsubject.

•ALS Functional RatingScale-Revised (ALSFRS-R)

•Slow Vital Capacity (SVC)

Enrollment:

86

Age:


Sex:

All

•WashingtonUniversitySchool ofMedicine



December 2012

Primary Completion:

October 2019

Study Completion:

October 2019

First Posted:

February 28, 2018


No Results Posted

Last Update Posted:

February 28, 2018


•Washington University in St.Louis, Saint Louis, Missouri,United States





- Page 9 of 56 -


FunderType

Dates Locations

15 NCT03411863 Cervical Electrical Stimulationfor ALS

Study Documents:

Title Acronym:

Other Ids:

B2527-P


•Device: CES at rest

•Device: CES plusactive hand or wristmovements

Study Type:

Interventional

Phase:

Not Applicable

Study Design:




Outcome Measures:

•Electromyographicresponses (rest)

•Electromyographicresponses (active)

Enrollment:

50

Age:


Sex:

All

•VA Office ofResearch andDevelopment

•U.S.Fed

Study Start:

January 4, 2018

Primary Completion:

December 31, 2019

Study Completion:

May 29, 2020

First Posted:

January 26, 2018


No Results Posted

Last Update Posted:

July 20, 2018

•James J. Peters VA MedicalCenter, Bronx, NY, Bronx, NewYork, United States

16 NCT03362658 Novel MRI Biomarkers forMonitoring Disease Progressionin ALS

Study Documents:

Title Acronym:

Other Ids:

RES0027887


•Motor NeuronDisease

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Change in corticalthickness in millimetres.

•Change in DTI indices(unitless).

Enrollment:

700

Age:


Sex:

All

•University ofAlberta

•University ofCalgary

•WesternUniversity,Canada

•McGill University

•University ofToronto

•University ofBritish Columbia

•Laval University


October 2016

Primary Completion:

December 2020

Study Completion:

December 2020

First Posted:

December 5, 2017


No Results Posted

Last Update Posted:

May 14, 2018


•University of Calgary / HeritageMedical Research Clinic,Calgary, Alberta, Canada

•University of Alberta,Edmonton, Alberta, Canada

•University of British Columbia /GF Strong Rehab Centre,Vancouver, British Columbia,Canada

•Western University / LondonHealth Sciences Centre,London, Ontario, Canada

•University of Toronto /Sunnybrook Health SciencesCentre, Toronto, Ontario,Canada

•McGill University / MontrealNeurological Institute andHospital, Montreal, Quebec,Canada

•Laval University, Quebec City,Quebec, Canada






- Page 10 of 56 -


FunderType

Dates Locations

17 NCT03334786 Study to Evaluate Safety &Efficacy of FLX-787-ODT toTreat Fasciculations in Tongueand Appendicular Muscle inAdult Subjects With ALS

Study Documents:

Title Acronym:

Other Ids:

FLX-787-107


•Fasciculation

•Drug: FLX-787-ODT

Study Type:

Interventional

Phase:

•Phase 1

•Phase 2

Study Design:




Outcome Measures:

•Change from Baseline ofDiastolic Blood Pressure inmmHg

•Change from Baseline ofSystolic Blood Pressure inmmHg

•Change from Baseline inHeart Rate in beats perminute

•Change from Baseline inRespiration Rate in breathsper minute

•Change from Baselinein Body Temperaturein degrees Celsius orFahrenheit

•Change from Baseline ofOral Cavity Examination

•Incidence of Treatment-Emergent Adverse Events

•Change from Baseline ofFasciculation Frequency

•Change from Baseline inPeak Tongue Strengthin kPa by Iowa OralPerformance Instrument

•Change from Baseline inSpeech Assessments

•Change from Baseline inSwallowing Assessments

Enrollment:

15

Age:


Sex:

All

•Flex Pharma,Inc.


April 5, 2018

Primary Completion:

August 2018

Study Completion:

August 2018

First Posted:

November 7, 2017


No Results Posted

Last Update Posted:

April 11, 2018

•Beth Israel DeaconessMedical Center, Boston,Massachusetts, United States






- Page 11 of 56 -


FunderType

Dates Locations

18 NCT03330353 Chromatic Pupillometry toAssess the Melanopsin-Light Pathway in ProgressiveSupranuclear Palsy

Study Documents:

•Study Protocol and StatisticalAnalysis Plan

•Informed Consent Form

Title Acronym:

PMPSP

Other Ids:

2017p001603

Recruiting •PSP - ProgressiveSupranuclear Palsy

•PD - Parkinson'sDisease

•AD - Alzheimer'sDisease

•ALS (AmyotrophicLateral Sclerosis)

•Diagnostic Test:Pupillometry

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Maximal Pupil Constriction

•Post-illumination pupilresponse (PIPR)

Enrollment:

56

Age:


Sex:

All


•NeurOptics Inc.

•University ofToronto

•Other

•Industry

Study Start:

November 1, 2017

Primary Completion:

October 1, 2019

Study Completion:

October 1, 2019

First Posted:

November 6, 2017


No Results Posted

Last Update Posted:

November 7, 2017


19 NCT03324399 A Study of Protein Metabolism,Microbiome and InvestigationalProbiotic Use in Patients WithALS

Study Documents:

Title Acronym:

Other Ids:

AIHG-2017.004-ALS



•ALS

•DietarySupplement:probiotic

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Evaluate amino acid levelsbefore and after probioticuse.

•Measure changes inquestionnaires relatingto subjective functionalassessments.

•Measure changes inQuality of Life.

•Evaluate pain levels withthe Numbered Pain Scale.

Enrollment:

15

Age:


Sex:

All

•AveraMcKennanHospital &University HealthCenter


June 1, 2017

Primary Completion:

July 2019

Study Completion:

July 2019

First Posted:

October 27, 2017


No Results Posted

Last Update Posted:

June 26, 2018

•Avera Medical GroupNeurology Sioux Falls, SiouxFalls, South Dakota, UnitedStates





https://ClinicalTrials.gov/ProvidedDocs/53/NCT03330353/Prot_SAP_001.pdf

https://ClinicalTrials.gov/ProvidedDocs/53/NCT03330353/Prot_SAP_001.pdf

https://ClinicalTrials.gov/ProvidedDocs/53/NCT03330353/ICF_002.pdf





- Page 12 of 56 -


FunderType

Dates Locations

20 NCT03280056 Safety and Efficacy of RepeatedAdministrations of NurOwn® inALS Patients

Study Documents:

Title Acronym:

Other Ids:

BCT-002-US

Recruiting •AmyotrophicLateral Sclerosis(ALS)

•Biological:NurOwn® (MSC-NTF cells)

•Other: Placebo

Study Type:

Interventional

Phase:

Phase 3

Study Design:





Outcome Measures:

•To evaluate the efficacyand safety of NurOwn®(autologous MSC-NTFcells) as compared toplacebo as measured bythe amyotrophic lateralsclerosis functional ratingscale (ALSFRS-R)

•Biomarkers

Enrollment:

200

Age:

18 Years to 60Years (Adult)

Sex:

All

•Brainstorm-CellTherapeutics

•CaliforniaInstitute forRegenerativeMedicine

•Industry

•Other

Study Start:

August 28, 2017

Primary Completion:

April 30, 2019

Study Completion:

July 30, 2019

First Posted:

September 12, 2017


No Results Posted

Last Update Posted:

May 25, 2018

•University of California IrvineAlpha Stem Cell Clinic, Irvine,California, United States

•Cedars-Sinai Medical Center,Los Angeles, California, UnitedStates



•University of MassachusettsMedical School, Worcester,Massachusetts, United States

•Mayo Clinic, Rochester,Minnesota, United States

21 NCT03268603 Intrathecal Autologous Adipose-derived Mesenchymal StromalCells for Amyotrophic LateralSclerosis (ALS)

Study Documents:

Title Acronym:

Other Ids:

•15-008008

•UL1TR000135

Recruiting •ALS


•Drug: AutologousAdipose-derivedMesenchymalStromal Cells

Study Type:

Interventional

Phase:

Phase 2

Study Design:




Outcome Measures:

•Number of Adverse Events

•Change in slope of ALSFunctional Rating Scale -Revised (ALSFRS-R)

Enrollment:

60

Age:


Sex:

All

•Mayo Clinic

•State ofMinnesotaRegenerativeMedicineMinnesota


October 10, 2017

Primary Completion:

December 2019

Study Completion:

December 2019

First Posted:

August 31, 2017


No Results Posted

Last Update Posted:

January 30, 2018

•Mayo Clinic in Rochester,Rochester, Minnesota, UnitedStates








- Page 13 of 56 -


FunderType

Dates Locations

22 NCT03241784 T-Regulatory Cells inAmyotrophic Lateral Sclerosis

Study Documents:

Title Acronym:

Other Ids:

Pro00013616


•ALS (AmyotrophicLateral Sclerosis)

•Biological:AutologousT-regulatorylymphocytes

•Biological:Interleukin-2

Study Type:

Interventional

Phase:

Phase 1

Study Design:




Outcome Measures:

•Number of participants withtreatment-related adverseevents as assessed byCTCAE v4.0

•AALS (Appel ALS) Scale

•ALSFRS-R (ALSFunctional Rating Scale-Revised)

•T-Regulatory Cells

•Treg Suppression

•TH17 and Th1lymphocytes

Enrollment:

4

Age:


Sex:

All

•Stanley H.Appel, MD

•The MethodistHospital System


May 16, 2016

Primary Completion:

February 2018

Study Completion:

March 2018

First Posted:

August 7, 2017


No Results Posted

Last Update Posted:

March 26, 2018

•Methodist NeurologicalInstitute, Houston, Texas,United States

23 NCT03225144 Investigating ComplexNeurodegenerative DisordersRelated to Amyotrophic LateralSclerosis and FrontotemporalDementia

Study Documents:

Title Acronym:

Other Ids:

•170131

•17-N-0131

Recruiting •FrontotemporalLobar Degeneration

•Amytrophic LateralSclerosis

•ProgressiveSupranuclear Palsy

Study Type:

Observational

Phase:

Study Design:


•Time Perspective: Cross-Sectional

Outcome Measures:

eligibility for researchprotocols

Enrollment:

200

Age:


Sex:

All


•NationalInstitutes ofHealth ClinicalCenter (CC)

•NIH Study Start:

October 11, 2017

Primary Completion:

June 30, 2022

Study Completion:

June 30, 2022

First Posted:

July 21, 2017


No Results Posted

Last Update Posted:

July 11, 2018

•National Institutes of HealthClinical Center, Bethesda,Maryland, United States








- Page 14 of 56 -


FunderType

Dates Locations

24 NCT03201991 ALS Study Determining VariousBiomarkers and StrengthComparison After Exercise

Study Documents:

Title Acronym:

ADVANCE

Other Ids:

STUDY00003843


•Other: ResistanceExercise Program

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Primary Purpose:Prevention

Outcome Measures:

Change in functional musclestrength

Enrollment:

7

Age:


Sex:

All



May 1, 2017

Primary Completion:

May 1, 2018

Study Completion:

May 1, 2018

First Posted:

June 28, 2017


No Results Posted

Last Update Posted:

June 28, 2017


25 NCT03202017 Lung Volume RecruitmentCombined With ExpiratoryMuscle Strength Training in ALS

Study Documents:

Title Acronym:

Other Ids:

NEUR-2017-25778


•Procedure:Expiratory MuscleStrength Training(EMST)

•Procedure: EMST+ Lung VolumeRecruitment (LVR)

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Masking: Single(Outcomes Assessor)

•Primary Purpose:Supportive Care

Outcome Measures:

•Peak Cough Flow

•Maximal ExpiratoryPressure

•Forced Vital Capacity

•Eating Assessment Tool -10 (EAT-10)

•Swallowing Related Qualityof Life (SWAL-QOL)

•Speech Intelligibility Test(SIT)

Enrollment:

24

Age:


Sex:

All

•University ofMinnesota -Clinical andTranslationalScience Institute


March 1, 2018

Primary Completion:

December 2020

Study Completion:

December 2021

First Posted:

June 28, 2017


No Results Posted

Last Update Posted:

May 7, 2018

•University of Florida,Gainesville, Florida, UnitedStates

•University of Minnesota,Minneapolis, Minnesota, UnitedStates







- Page 15 of 56 -


FunderType

Dates Locations

26 NCT03196375 A Study to Assess FLX-787 inSubjects With Motor NeuronDisease Experiencing MuscleCramps.

Study Documents:

Title Acronym:

Other Ids:

FLX-787-203



•Drug: FLX-787-ODT (orallydisintegratingtablet)

•Drug: Placebo ODT

Study Type:

Interventional

Phase:

Phase 2

Study Design:





Outcome Measures:

Cramp frequency

Enrollment:

120

Age:


Sex:

All

•Flex Pharma,Inc.


July 28, 2017

Primary Completion:

June 2018

Study Completion:

June 2018

First Posted:

June 22, 2017


No Results Posted

Last Update Posted:

June 14, 2018

•Honor Health ResearchInstitute, Scottsdale, Arizona,United States

•Mayo Clinic, Scottsdale,Arizona, United States

•California Pacific MedicalCenter, Sacramento, California,United States

•University of California - Davis,Sacramento, California, UnitedStates

•University of California SanFrancisco, San Francisco,California, United States

•University of Colorado, Aurora,Colorado, United States

•Hospital for Special Care, NewBritain, Connecticut, UnitedStates

•GW Medical Faculty AssociatesInc., Washington, District ofColumbia, United States

•Mayo Clinic, Jacksonville,Florida, United States

•University of South FloridaHealth, Tampa, Florida, UnitedStates

•and 25 more





- Page 16 of 56 -


FunderType

Dates Locations

27 NCT03192358 Physiological Flow of LiquidsUsed in Dysphagia Management

Study Documents:

Title Acronym:

Other Ids:

•DC011020

•5R01DC011020-05



•Dysphagia

•Diagnostic Test:VideofluoroscopicSwallowingExamination

•Other: TongueStrengthMeasurement

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Penetration-AspirationScale (Swallow Safety)

•Normalized Residue RatioScale (Swallow Efficiency)

•Number of Swallows perBolus (Swallow Efficiency)

•Pharyngeal TransitDuration (Bolus Flow)

•Time to LaryngealVestibule Closure (SwallowKinematics)

•Hyoid Bone Range ofMovement (SwallowKinematics)

•Hyoid Speed/Velocity(Swallow Kinematics)

•Change in AnteriorMaximum TonguePressure (IOPI)

•Change in PosteriorMaximum TonguePressure (IOPI)

•Change in Saliva SwallowTongue Pressure (IOPI)

Enrollment:

40

Age:


Sex:

All

•UniversityHealth Network,Toronto

•University ofFlorida


•Other

•NIH

Study Start:

November 1, 2017

Primary Completion:

August 2019

Study Completion:

February 28, 2021

First Posted:

June 20, 2017


No Results Posted

Last Update Posted:

November 9, 2017




- Page 17 of 56 -


FunderType

Dates Locations

28 NCT03168711 Safety of Urate Elevation inAmyotrophic Lateral Sclerosis(ALS)

Study Documents:

Title Acronym:

SURE-ALS2

Other Ids:

SURE-ALS2


•Drug: Inosine

•Drug: Placebo

Study Type:

Interventional

Phase:

Phase 2

Study Design:





Outcome Measures:

•Safety Will be Assessed bythe Occurrence of AdverseEvents

•Tolerability to Completethe Entire 20 Week Studyon Study Drug

Enrollment:

30

Age:


Sex:

All


•The SalahFoundation

•MGH cure ALSFund


October 1, 2017

Primary Completion:

October 2019

Study Completion:

January 2020

First Posted:

May 30, 2017


No Results Posted

Last Update Posted:

February 1, 2018

•Holy Cross Hospital, FortLauderdale, Florida, UnitedStates






- Page 18 of 56 -


FunderType

Dates Locations

29 NCT03160898 A Study to Evaluate Efficacy,Safety and Tolerability ofCK-2127107 in Patients WithAmyotrophic Lateral Sclerosis(ALS)

Study Documents:

Title Acronym:

FORTITUDE-ALS

Other Ids:

CY 5022


•Drug: CK-2127107

•Drug: Placebo

Study Type:

Interventional

Phase:

Phase 2

Study Design:





Outcome Measures:

•Change from baseline toWeek 12 in the percentpredicted slow vitalcapacity (SVC)

•Slope of change frombaseline in the mega-score of muscle strengthmeasured by handheld dynamometry andhandgrip dynamometryfrom baseline to Week 12

•Change from baselineto Week 12 in the ALSFunctional Rating Scale -Revised (ALSFRS-R)

•Mean plasmaconcentrations over time ofCK-2127107 at Week 12

Enrollment:

445

Age:


Sex:

All

•Cytokinetics

•Astellas PharmaInc


July 24, 2017

Primary Completion:

March 2019

Study Completion:

March 2019

First Posted:

May 19, 2017


No Results Posted

Last Update Posted:

August 1, 2018

•St. Joseph's Hospital andMedical Center - BarrowNeurological Clinics, Phoenix,Arizona, United States


•University of California Irvine,Orange, California, UnitedStates

•Forbes Norris MDA/ALSResearch Center, SanFrancisco, California, UnitedStates

•Stanford Hospital and Clinics,Stanford, California, UnitedStates

•University of Colorado HospitalAnschutz Outpatient Pavilion,Aurora, Colorado, UnitedStates


•George Washington UniversityMedical Faculty Associates,Washington, District ofColumbia, United States



•and 50 more






- Page 19 of 56 -


FunderType

Dates Locations

30 NCT03127514 AMX0035 in Patients WithAmyotrophic Lateral Sclerosis(ALS)

Study Documents:

Title Acronym:

CENTAUR

Other Ids:

AMX-3500



•NeuromuscularDiseases

•NeurodegenerativeDiseases

•Spinal CordDiseases

•TDP-43Proteinopathies

•Nervous SystemDiseases

•Central NervousSystem Diseases

•Drug: AMX0035

•Other: Placebo

Study Type:

Interventional

Phase:

Phase 2

Study Design:





Outcome Measures:

•ALSFRS-R Slope

•Incidence of AdverseEvents

•Proportion of subjects ineach group able to remainon study drug until planneddiscontinuation

•Accurate Testing of LimbIsometric Strength (ATLIS)

•Blood-based Biomarkers

•Slow Vital Capacity

•Survival, tracheostomy andhospitalizations

•Imaging Biomarkers

Enrollment:

132

Age:


Sex:

All

•AmylyxPharmaceuticalsInc.

•ALS Finding aCure Foundation

•ALS Association

•Northeast ALSConsortium

•MassachusettsGeneral HospitalNeurologyClinicalResearchInstitute

•LeandroP. RizzutoFoundation

•Industry

•Other

Study Start:

June 22, 2017

Primary Completion:

December 2018

Study Completion:

May 2019

First Posted:

April 25, 2017


No Results Posted

Last Update Posted:

May 22, 2018

•Barrow Neurological Institute,Phoenix, Arizona, United States

•UC Irvine Medical Center,Orange, California, UnitedStates

•Forbes Norris MDA/ALSResearch Center - CaliforniaPacific Medical Center, SanFrancisco, California, UnitedStates

•University of Florida MedicalCenter, Gainesville, Florida,United States

•Carol and Frank Morsini Centerfor Advanced Health Care -University of South Florida,Tampa, Florida, United States

•Emory University Hospital,Atlanta, Georgia, United States

•University of Iowa Hospitalsand Clinics, Iowa City, Iowa,United States

•University of Kentucky MedicalCenter, Lexington, Kentucky,United States

•Ochsner NeuroscienceInstitute, New Orleans,Louisiana, United States

•Johns Hopkins Hospital,Baltimore, Maryland, UnitedStates

•and 15 more




- Page 20 of 56 -


FunderType

Dates Locations

31 NCT03095989 An Online MindfulnessIntervention for People With ALSand Their Caregivers

Study Documents:

Title Acronym:

Other Ids:

IRB14-3695


•Behavioral:Mindfulness

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Masking: Single(Outcomes Assessor)


Outcome Measures:

•Quality of Life

•Depression and anxiety

•The patient's perception ofphysical impairment

•Physician-assessedphysical impairment

•Vital capacity (VC)

•Cognitive and behavioralfunction

•Caregiver burden(caregivers only)

Enrollment:

100

Age:


Sex:

All

•HarvardUniversity

•ALS Association

•Milton S.Hershey MedicalCenter

•CatholicUniversity of theSacred Heart


January 2015

Primary Completion:

December 2018

Study Completion:

December 2018

First Posted:

March 30, 2017


No Results Posted

Last Update Posted:

March 29, 2018

•Penn State Hershey MedicalCenter, Hershey, Pennsylvania,United States

32 NCT03090932 Longitudinal Study of InnateLymphoid Cells in PeripheralBlood in ALS

Study Documents:

Title Acronym:

Other Ids:

HUM00107546


•Other: Blood draw Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Total number of classicalNK (natural killer) cells;total number of CD3+CD4+ CD8+ cells

•Cytokine expression

Enrollment:

40

Age:


Sex:

All

•University ofMichigan

•University ofSouth Florida


January 18, 2016

Primary Completion:

December 31, 2018

Study Completion:

July 1, 2019

First Posted:

March 27, 2017


No Results Posted

Last Update Posted:

January 23, 2018

•University of Michigan, AnnArbor, Michigan, United States







- Page 21 of 56 -


FunderType

Dates Locations

33 NCT03068754 A Study to Assess the Efficacyand Safety of H.P. Acthar® Gelin the Treatment of SubjectsWith Amyotrophic LateralSclerosis

Study Documents:

Title Acronym:

Other Ids:

MNK14042068


•Drug: Acthar

•Drug: Placebo

Study Type:

Interventional

Phase:

Phase 2

Study Design:





Outcome Measures:

•Telephone administeredAmyotrophic LateralSclerosis Functional RatingScale Revised (ALSFRS-R)

•Telephone administeredALSFRS-R total scoredecline

•Investigator administeredALSFRS-R total scoredecline

•Telephone administeredALSFRS-R total score andinvestigator administeredALSFRS-R total score

•Pulmonary function testA: Mean slope of percentpredicted forced vitalcapacity test

•Pulmonary function testB: Mean slope of volumeexpired in 1 second test

•Columbia-Suicide SeverityRating Scale (C-SSRS)

•Telephone administeredALSFRS-R total score

•Pulmonary function test A

•Pulmonary function text B

•Survival

Enrollment:

213

Age:


Sex:

All

•Mallinckrodt •Industry Study Start:

June 22, 2017

Primary Completion:

December 2019

Study Completion:

December 2019

First Posted:

March 3, 2017


No Results Posted

Last Update Posted:

August 13, 2018

•Neuromuscular ResearchCenter, Phoenix, Arizona,United States

•Mayo Clinic - Arizona,Scottsdale, Arizona, UnitedStates

•University of California SanDiego, La Jolla, California,United States

•Loma Linda University HealthSystem, Department ofNeurology, Loma Linda,California, United States

•Keck School of Medicine,University of SouthernCalifornia, Los Angeles,California, United States

•University of CaliforniaLos Angeles, Los Angeles,California, United States

•University of California IrvineMedical Center, Orange,California, United States


•University of California SanFrancisco, San Francisco,California, United States

•Colorado Springs NeurologicalAssociates, Colorado Springs,Colorado, United States

•and 33 more






- Page 22 of 56 -


FunderType

Dates Locations

34 NCT03070119 Long-Term Evaluation ofBIIB067

Study Documents:

Title Acronym:

Other Ids:

•233AS102

•2016-003225-41


•ALS Causedby SuperoxideDismutase 1(SOD1) Mutation

•Drug: BIIB067 Study Type:

Interventional

Phase:

Phase 1

Study Design:





Outcome Measures:

•Number of participantsexperiencing AEs andserious adverse events(SAEs)

•PK parameter of BIIB067in plasma: Maximumobserved concentration(Cmax)

•PK parameter of BIIB067in cerebrospinal fluid(CSF): Cmax

•PK parameter of BIIB067in plasma: Time to reachthe maximum observedconcentration (Tmax)

•PK parameter of BIIB067in CSF: Tmax

•PK parameter of BIIB067in plasma: Area underthe concentration-timecurve from time 0 to infinity(AUCinf)

•PK parameter of BIIB067in CSF: AUCinf

•PK parameter of BIIB067in plasma: Area under theconcentration-time curvefrom time 0 to time of thelast measurable (AUClast)

•PK parameter of BIIB067in CSF: AUClast

•PK parameter of BIIB067in plasma: Apparentterminal elimination half-life(t½)

•PK parameter of BIIB067in CSF: t½

Enrollment:

48

Age:


Sex:

All

•Biogen

•IonisPharmaceuticals,Inc.


March 8, 2017

Primary Completion:

January 31, 2020

Study Completion:

January 31, 2020

First Posted:

March 3, 2017


No Results Posted

Last Update Posted:

August 15, 2018

•Research Site, Phoenix,Arizona, United States

•Research Site, La Jolla,California, United States

•Research Site, San Francisco,California, United States

•Research Site, Orlando,Florida, United States

•Research Site, Atlanta,Georgia, United States

•Research Site, Baltimore,Maryland, United States

•Research Site, Boston,Massachusetts, United States

•Research Site, Saint Louis,Missouri, United States

•Research Site, Knoxville,Tennessee, United States

•Research Site, Leuven,Belgium

•and 4 more



- Page 23 of 56 -


FunderType

Dates Locations

35 NCT03049046 CC100: Phase 1 Multiple-Dose Safety and Tolerability inSubjects With ALS

Study Documents:

Title Acronym:

CC100B

Other Ids:

•CC100B

•1R01FD004790-01A2


•Drug: CC100

•Drug: Placebos

Study Type:

Interventional

Phase:

Phase 1

Study Design:



•Masking: Double(Participant, Investigator)


Outcome Measures:

•Safety and Tolerability:Adverse events, safetylabs, vital signs, and ECGs

•Pharmacokinetics (PK)--Peak plasma concentration(Cmax)

•Pharmacokinetics (PK)--Area under the plasmaconcentration versus timecurve (AUC)

•Pharmacokinetics (PK)--Half life (T 1/2)

•Pharmacodynamics (PD)--Monocyte chemotacticprotein 1 (MCP-1)

•Pharmacodynamics (PD)--Excitotoxicity/oxidativestress biomarkers

Enrollment:

21

Age:

18 Years to 64Years (Adult)

Sex:

All

•Chemigen, LLC •Industry Study Start:

April 7, 2017

Primary Completion:

January 30, 2018

Study Completion:

March 30, 2018

First Posted:

February 9, 2017


No Results Posted

Last Update Posted:

August 3, 2017

•Indiana University, IU HealthPhysicians Neurology,Indianapolis, Indiana, UnitedStates




- Page 24 of 56 -


FunderType

Dates Locations

36 NCT03020797 A Clinical Trial to Evaluate theSafety and Efficacy of Fycompain Subjects With AmyotrophicLateral Sclerosis (ALS)

Study Documents:

Title Acronym:

Other Ids:

Eisai-01


•Drug: Perampanel

•Drug: Placebo OralTablet

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Incidence of treatment-emergent adverse events

•Efficacy as measuredby change in ALSFRS-R score (ALS functionalrating scale-revised);

Enrollment:

60

Age:


Sex:

All

•Stony BrookUniversity

•Eisai Inc.

•Other

•Industry

Study Start:

December 2016

Primary Completion:

December 2018

Study Completion:

First Posted:

January 13, 2017


No Results Posted

Last Update Posted:

January 13, 2017

•Stony Brook University MedicalCenter, Stony Brook, NewYork, United States

37 NCT03016897 ALS Testing Through Home-based Outcome Measures

Study Documents:

Title Acronym:

ALS AT HOME

Other Ids:

BNI_ALS_001



•Other:Respirometer,Handgrip Meter,Skulpt Chisel,ActigraphyMeter

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Change in PulmonaryFunction

•Change in QuantitativeHand Grip

•Change in ElectricalImpedance Myography(EIM) Measurements

•Change in Actigraphy

•ALSFRS-R

•Change in Patient-reportedExperience measures(PREMs)

•Adverse Events

•Change in Voice/SpeechTracking

Enrollment:

250

Age:


Sex:

All

•Jeremy Shefner

•Beth IsraelDeaconessMedical Center

•BarrowNeurologicalInstitute


February 22, 2017

Primary Completion:

December 2018

Study Completion:

June 2019

First Posted:

January 11, 2017


No Results Posted

Last Update Posted:

August 7, 2018








- Page 25 of 56 -


FunderType

Dates Locations

38 NCT02962050 Delineating SwallowingImpairment and Decline in ALS

Study Documents:

Title Acronym:

Other Ids:

•IRB201602098-N

•NS100859


•Procedure:VideofluoroscopicSwallowing Study(VFSS)

•Procedure:High ResolutionManometry

•Other: DIGEST

•Other: PenetrationAspiration Scale

•Other: NormalizedResidue RatioScale

•Device: VoluntaryPeak Cough FlowTesting

•Device: IowaOral PerformanceInstrument

•Device: LingualElectricalImpedanceMyography

•Drug: CapsaicinChallenge

•Device: PulmonaryFunction Testing

•Other: EatingAssessment Tool10

•Other: The Centerfor NeurologicStudy BulbarFunction Scale

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Change in MaximumSwallowing Pressurewith High ResolutionManometry (HRM)

•Change in Rate ofPressure with HighResolution Manometry(HRM)

•Change in Mean Pressurewith High ResolutionManometry (HRM)

•Swallowing Safety (withDIGEST)

•Swallowing Efficiency (withDIGEST)

•Swallowing Efficiency (withNRRS)

•Swallowing Safety (withPAS)

•Change in ForcedVital Capacity withPulmonary FunctionTesting (with hand-helddigital manometer)

•Voluntary Peak CoughFlow Testing (withElectronic Peak CoughFlow Meter Device)

•Change in Lingual Strengthwith Lingual FunctionTesting (with IOPI)

•and 11 more

Enrollment:

110

Age:


Sex:

All


•NationalInstitutes ofHealth (NIH)

•Other

•NIH

Study Start:

May 31, 2017

Primary Completion:

June 30, 2022

Study Completion:

June 30, 2024

First Posted:

November 11, 2016


No Results Posted

Last Update Posted:

July 6, 2018


•University of Florida College ofMedicine, Jacksonville, Florida,United States




- Page 26 of 56 -


FunderType

Dates Locations

39 NCT02943850 CNS10-NPC-GDNF for theTreatment of ALS

Study Documents:

Title Acronym:

Other Ids:

Pro00042350


•Biological:Stem cell (HPC)implantation

•Device:Stereotacticsurgical device

Study Type:

Interventional

Phase:

Phase 1

Study Design:




Outcome Measures:

•Safety evaluated byAdverse Events andSerious Adverse Events,post-operative MRI,and clinical laboratoryassessments

•Compound Motor ActionPotential (CMAP)

•Force Generation viaATLIS testing

•Quantitative Muscle MRI

•Electrical ImpedanceMyography (EIM)

•Assessment of glial cellline derived neurotrophicfactor (GDNF) in thecerebral spianl fluid (CSF)

Enrollment:

18

Age:


Sex:

All

•Cedars-SinaiMedical Center

•CaliforniaInstitute forRegenerativeMedicine


April 1, 2017

Primary Completion:

April 2019

Study Completion:

April 2019

First Posted:

October 25, 2016


No Results Posted

Last Update Posted:

August 3, 2017




- Page 27 of 56 -


FunderType

Dates Locations

40 NCT02936635 A Study for Patients WhoCompleted VITALITY-ALS (CY4031)

Study Documents:

Title Acronym:

VIGOR-ALS

Other Ids:

•CY 4033

•2016-002629-13


•AmyotrophicLateral Sclerosis(ALS)

•Drug: tirasemtiv Study Type:

Interventional

Phase:

Phase 3

Study Design:




Outcome Measures:

•Incidence of adverseevents (AEs) in patientpopulation

•Time to first use ofassisted ventilation ordeath

•Time to the first occurrenceof respiratory insufficiency(defined as tracheostomyor the use of non-invasiveventilation (NIV) for #22hours per day for #10consecutive days) or death

•Time to death

•Decline in percentpredicted Slow VitalCapacity (SVC) frombaseline

•Decline in ALS FunctionalRating Scale - Revised(ALSFRS-R) score frombaseline

•Slope of the changefrom baseline in percentpredicted SVC

•Slope of the change frombaseline in ALSFRS-R

Enrollment:

280

Age:


Sex:

All

•Cytokinetics •Industry Study Start:

October 2016

Primary Completion:

October 2019

Study Completion:

October 2019

First Posted:

October 18, 2016


No Results Posted

Last Update Posted:

December 8, 2017

•St. Joseph's Hospital andMedical Center - BarrowNeurology Clinics, Phoenix,Arizona, United States


•University of California, Irvine,Orange, California, UnitedStates

•UC Davis Medical Center,Sacramento, California, UnitedStates

•Forbes Norris MDA/ALSResearch Center, SanFrancisco, California, UnitedStates

•Stanford Hospital and Clinics,Stanford, California, UnitedStates

•University of Colorado HospitalAnschutz Outpatient Pavilion,Aurora, Colorado, UnitedStates


•George Washington UniversityMedical Center, Washington,District of Columbia, UnitedStates


•and 57 more




- Page 28 of 56 -


FunderType

Dates Locations

41 NCT02916966 Population-Based Ohio ALSRepository and ALS RiskFactors

Study Documents:

Title Acronym:

Other Ids:

D06019


•Other: PatientRegistry

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Questionnaire forEnvironmental Exposures,Toxins, and NeurologicalDisease

Enrollment:

1000

Age:


Sex:

All

•Dartmouth-HitchcockMedical Center

•The ClevelandClinic


October 2016

Primary Completion:

September 2018

Study Completion:

October 2018

First Posted:

September 28, 2016


No Results Posted

Last Update Posted:

April 13, 2018

•Cleveland Clinic Foundation,Cleveland, Ohio, United States




- Page 29 of 56 -


FunderType

Dates Locations

42 NCT02872142 Efficacy and Safety of PlasmaExchange With Albutein® 5%in Patients With AmyotrophicLateral Sclerosis

Study Documents:

Title Acronym:

Other Ids:

GBI1501


•Biological: Albutein5%

Study Type:

Interventional

Phase:

Phase 2

Study Design:




Outcome Measures:

•Changes from baseline inthe ALS Functional RatingScale - Revised

•Changes from baseline inforced vital capacity

•Changes from baselinein cognitive functiondetermined by the ALS- Cognitive BehavioralScreen test

•Changes from baseline inthe motor evoked potentialin thenar and hypothenareminence and anteriortibialis muscle determinedby electromyography

•Evaluation of quality of lifeusing the ALS AssessmentQuestionnaire 40

•Changes from baselinein plasma humanapolipoproteins

•Changes from baseline incerebrospinal fluid humanapolipoproteins

•Changes from baseline inplasma beta-methylamino-L-alanine levels

•Changes from baseline incerebrospinal fluid beta-methylamino-L-alaninelevels

•Changes from baseline inabsolute leukocyte count

•Changes from baselinein plasma neurofilamentanalysis

•Changes from baselinein cerebrospinal fluidneurofilament analysis

Enrollment:

10

Age:


Sex:

All

•GrifolsTherapeuticsLLC

•GrifolsBiologicals Inc.


July 2016

Primary Completion:

January 2019

Study Completion:

January 2019

First Posted:

August 19, 2016


No Results Posted

Last Update Posted:

May 11, 2018

•Dartmouth-Hitchcock MedicalCenter, Lebanon, NewHampshire, United States





- Page 30 of 56 -


FunderType

Dates Locations

43 NCT02851914 SSRIs vs. TCAs for Depressionin ALS Patients

Study Documents:

Title Acronym:

Other Ids:

22974

Recruiting •Depression


•Drug: TricyclicAntidepressants("TCA")

•Drug: SelectiveSerotonin UptakeInhibitors ("SSRI")

Study Type:

Interventional

Phase:

Early Phase 1

Study Design:





Outcome Measures:

•BDI-II

•ANCOVA

Enrollment:

40

Age:


Sex:

All

•St. LouisUniversity


July 21, 2015

Primary Completion:

December 2018

Study Completion:

December 2018

First Posted:

August 2, 2016


No Results Posted

Last Update Posted:

February 12, 2018

•Monteleone Hall, Saint LouisUniversity, 1438 South GrandBlvd., Saint Louis, Missouri,United States

44 NCT02795897 Genomic Translation for ALSCare

Study Documents:

Title Acronym:

GTAC

Other Ids:

AAAQ7026

Recruiting •ALS Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Correlation of DNAgenotype with ALSphenotypes

•Correlation of geneexpression in blood withALS phenotypes

Enrollment:

1500

Age:


Sex:

All

•ColumbiaUniversity

•ALS Association

•Biogen

•Other

•Industry

Study Start:

November 2016

Primary Completion:

June 2019

Study Completion:

November 2020

First Posted:

June 10, 2016


No Results Posted

Last Update Posted:

June 8, 2018

•Cedar Sinai Medical Center,Los Angeles, California, UnitedStates

•Univeristy of Michigan, AnnArbor, Michigan, United States


•Washington University, SaintLouis, Missouri, United States

•Columbia University, New York,New York, United States

•Duke University, Durham, NorthCarolina, United States

•Oregon Health & SciencesUniversity, Portland, Oregon,United States

•Penn State Collegeof Medicine, Hershey,Pennsylvania, United States

•University of PittsburghMedical Center, Pittsburgh,Pennsylvania, United States

•Houston MethodistNeurological Institute, Houston,Texas, United States

•and 3 more





- Page 31 of 56 -


FunderType

Dates Locations

45 NCT02781454 Mexiletine in SporadicAmyotrophic Lateral Sclerosis

Study Documents:

Title Acronym:

Mexiletine-2

Other Ids:

MX-ALS-002


•SporadicAmyotrophicLateral Sclerosis

•Drug: Mexiletine

•Drug: Placebo

Study Type:

Interventional

Phase:

Phase 2

Study Design:





Outcome Measures:

•Change in resting motorthreshold

•Effects on motor evokedpotential (MEP)

•Effects on strengthduration time constant

•Effect on frequency andseverity of muscle cramps

•Effects on cortical silentperiod

•Effects on short-intervalintracortical inhibition(SICI)

•Effects on thresholdelectrotonus

•Effect on frequency andseverity of fasciculations(muscle twitching)

Enrollment:

60

Age:


Sex:

All

•University ofWashington



October 2016

Primary Completion:

September 30, 2018

Study Completion:

December 31, 2018

First Posted:

May 24, 2016


No Results Posted

Last Update Posted:

August 1, 2018


•University of California, Irvine,Orange, California, UnitedStates

•Augusta University, Augusta,Georgia, United States


•University of Michigan, AnnArbor, Michigan, United States

•Columbia Universtiy MedicalCenter, New York, New York,United States

•Pennsylvania State HersheyMedical Center, Hershey,Pennsylvania, United States

•University of Pittsburgh,Pittsburgh, Pennsylvania,United States

•Medical University of SouthCarolina, Charleston, SouthCarolina, United States

•University of Washington,Seattle, Washington, UnitedStates



- Page 32 of 56 -


FunderType

Dates Locations

46 NCT02750982 Laughter Therapy Effects onMood, Stress and Self-efficacyin People With NeurologicalDiseases.

Study Documents:

Title Acronym:

Other Ids:

TRBROWN201601

Recruiting •Alzheimer'sDisease


•Brain Injury

•Huntington'sDisease

•Multiple Sclerosis

•Parkinson'sDisease

•Stroke

•Spinal Cord Injury

•Other: LaughterTherapy

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Primary Purpose: HealthServices Research

Outcome Measures:

•Patient HealthQuestionnaire (PHQ-9, fordepression)

•Generalized AnxietyDisorder 7-item scale(GAD-7, for anxiety)

•The General Self-EfficacyScale (GSE)

Enrollment:

24

Age:


Sex:

All

•Brown,Theodore R.,M.D., MPH


July 2016

Primary Completion:

August 2018

Study Completion:

December 2018

First Posted:

April 26, 2016


No Results Posted

Last Update Posted:

January 23, 2018

•Evergreen Healthcare,Kirkland, Washington, UnitedStates





- Page 33 of 56 -


FunderType

Dates Locations

47 NCT02714036 A Biomarker Study to EvaluateMN-166 (Ibudilast) in SubjectsWith Amyotrophic LiteralSclerosis (ALS)

Study Documents:

Title Acronym:

Other Ids:

MN-166-ALS-1202



•Drug: ibudilast Study Type:

Interventional

Phase:

•Phase 1

•Phase 2

Study Design:




Outcome Measures:

•To measure the impactof MN-166 (ibudilast) on[11C]-PBR28 uptake in themotor cortices and brainstem measured by positronemission tomography(PET) imaging at 24 weeks

•To measure the impactof MN-166 (ibudilast) onseveral markers of neuro-inflammation measured byblood biomarkers

•To evaluate the safety andtolerability of MN-166 byassessing the number oftreatment-related adverseevents.

•To evaluate the effect ofibudilast on ALS functionalrating scale-revised(ALSFRS-R)

•To evaluate the effectof ibudilast on slow vitalcapacity (SVC)

•To evaluate the effect ofibudilast on strength asmeasured by Hand-helddynamometry (HHD)

Enrollment:

35

Age:


Sex:

All

•MediciNova


•South ShoreNeurologicAssociates

•Industry

•Other

Study Start:

March 2016

Primary Completion:

June 28, 2018

Study Completion:

April 2019

First Posted:

March 21, 2016


No Results Posted

Last Update Posted:

July 20, 2018


•South Shore NeurologicAssociates, P.C., Patchogue,New York, United States





- Page 34 of 56 -


FunderType

Dates Locations

48 NCT02710110 Respiratory Strength Trainingin Persons With AmyotrophicLateral Sclerosis (ALS)

Study Documents:

Title Acronym:

Other Ids:

IRB201501172



•Device: PowerLungtrainer

•Device: MicroMouth PressureMeter

•Procedure:PulmonaryFunction Testing

•Procedure:Videofluoroscopicswallowing study

•Other: SwallowingQuality of LifeQuestionnaire

•Device: IowaOral PressureInstrument

•Drug: Capsaicin

Study Type:

Interventional

Phase:

Early Phase 1

Study Design:



•Masking: Single(Participant)


Outcome Measures:

•Maximum ExpiratoryPressure will be measuredbetween the groups for achange from baseline tomonth 3

•Maximum InspiratoryPressure will be measuredbetween the groups for achange from baseline tomonth 3

•Pulmonary function tomeasure the forced vitalcapacity (FVC) betweenthe groups for a changefrom baseline to month 3

•Sniff Nasal InspiratoryPressure will be measuredbetween the groups for achange from baseline tomonth 3

•Pulmonary functionto measure the peakexpiratory flow (PEF) willbe measured between thegroups for a change frombaseline to month 3

•Pulmonary function tomeasure the forcedexpiratory volume (FEV1)will be measured betweenthe groups for a changefrom baseline to month 3

•The Penetration-aspirationscale will be used tomeasure swallowingfunction

•Lingual strength will bemeasured between thegroups for a change frombaseline to month 3

•Lingual endurance will bemeasured between thegroups for a change frombaseline to month 3

•Voluntary cough functionwill be measured betweenthe groups for a changefrom baseline to month 3

•Reflexive cough will bemeasured between thegroups for a change frombaseline to month 3

Enrollment:

46

Age:


Sex:

All


•ALS Association


April 2016

Primary Completion:

November 30, 2017

Study Completion:

March 2020

First Posted:

March 16, 2016


No Results Posted

Last Update Posted:

April 5, 2018

•UF Health Shands, Gainesville,Florida, United States




- Page 35 of 56 -


FunderType

Dates Locations

49 NCT02686268 Understanding ClinicalPhenotype and CollectingBiomarker Samples in C9ORF72ALS

Study Documents:

Title Acronym:

Other Ids:

14LGCA123


•C9ORF72AmyotrophicLateral Sclerosis(ALS)

Study Type:

Observational

Phase:

Study Design:

•Observational Model:Case-Only


Outcome Measures:

•Collection of clinical dataand biomarker samples

•Correlation of repeatexpansion size with clinicaloutcome measures anddetermination of C9ORF72patients eligibility forclinical trials

Enrollment:

128

Age:


Sex:

All



•UMC Utrecht

•Johns HopkinsUniversity

•Sentara HealthCare/SentaraNeurologySpecialists


•University ofMassachusetts,Amherst

•Biogen

•ALS Association

•ColumbiaUniversity

•Other

•Industry

Study Start:

February 2015

Primary Completion:

December 31, 2017

Study Completion:

June 2018

First Posted:

February 19, 2016


No Results Posted

Last Update Posted:

February 8, 2018

•Cedars Sinai Medical Center,Los Angeles, California, UnitedStates

•Johns Hopkins, Baltimore,Maryland, United States

•University of Massachusetts,Amherst, Massachusetts,United States


•Washington University in St.Louis, Saint Louis, Missouri,United States

•Columbia University MedicalCenter, New York, New York,United States

•Sentara Health Care / SentaraNeurology Specialists, VirginiaBeach, Virginia, United States

•UMC Utrecht, Utrecht,Netherlands





- Page 36 of 56 -


FunderType

Dates Locations

50 NCT02682030 The Use of Airway ClearanceDevices in ALS

Study Documents:

Title Acronym:

Other Ids:

Pro00039699


•Device: HighFrequency ChestCompressionDevice (HFCC)

•Device: CoughAssist

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Change in Chest X-Raybetween baseline and endof study

•Change in Lung VentilationScan between baselineand end of study

•Change in McGill Singleitem quality of life questionbetween baseline and endof study

•Change in Forced VitalCapacity (FVC) betweenbaseline and end of study

•Change in MaximalInspiratory Pressure (MIP)between baseline and endof study

•Change in DiffusionCapacity between baselineand end of study

Enrollment:

20

Age:


Sex:

All



March 2016

Primary Completion:

December 2018

Study Completion:

December 2018

First Posted:

February 15, 2016


No Results Posted

Last Update Posted:

April 5, 2018




- Page 37 of 56 -


FunderType

Dates Locations

51 NCT02655614 A Study of GDC-0134to Determine InitialSafety, Tolerability, andPharmacokinetic Parameters inParticipants With AmyotrophicLateral Sclerosis

Study Documents:

Title Acronym:

Other Ids:

•GN29823

•2017-002931-41


•Drug: GDC-0134

•Drug: Placebo

•Drug: Rabeprazole

•Drug: Midazolam

•Drug: Caffeine

Study Type:

Interventional

Phase:

Phase 1

Study Design:



•Masking: Double(Participant, Investigator)


Outcome Measures:

•Percentage of ParticipantsWith Adverse Events (AEs)

•Percentage of ParticipantsWith Clinically SignificantLaboratory Abnormalities

•Percentage of ParticipantsWith Clinically SignificantVital Signs Abnormalities

•Percentage of ParticipantsWith Clinically SignificantElectrocardiogram (ECG)Abnormalities

•Percentage of ParticipantsWith Clinically SignificantAbnormalities in PhysicalExamination Findings

•Maximum PlasmaConcentration (Cmax) ofGDC-0134

•Time to Maximum PlasmaConcentration (tmax) ofGDC-0134

•Area Under the PlasmaConcentration Versus TimeCurve (AUC) of GDC-0134

•Apparent Clearance (CL/F)of GDC-0134

•Apparent Terminal Volumeof Distribution (Vz/F) ofGDC-0134

•and 9 more

Enrollment:

82

Age:


Sex:

All

•Genentech, Inc. •Industry Study Start:

May 31, 2016

Primary Completion:

October 29, 2019

Study Completion:

October 29, 2019

First Posted:

January 14, 2016


No Results Posted

Last Update Posted:

August 14, 2018

•Forbes Norris Mda/als Ctr;Research Center, SanFrancisco, California, UnitedStates

•Mayo Clinic Hospital - Florida,Jacksonville, Florida, UnitedStates

•University of Miami MillerSchool of Medicine, Miami,Florida, United States

•Bioclinica Research, Orlando,Florida, United States

•The Emory ALS Clinic, Atlanta,Georgia, United States

•Johns Hopkins UniversitySchool of Medicine, Baltimore,Maryland, United States


•Wake Research Associates,Raleigh, North Carolina, UnitedStates

•New Orleans Center forClinical Research, Knoxville,Tennessee, United States

•Methodist NeurologicalInstitute, Houston, Texas,United States

•MUCH - Montreal NeurologicalInstitute & Hospital, Montreal,Quebec, Canada

•UMC Utrecht, Utrecht,Netherlands







- Page 38 of 56 -


FunderType

Dates Locations

52 NCT02623699 Single and Multiple Dose Studyof BIIB067 in Adults WithAmyotrophic Lateral Sclerosis(ALS)

Study Documents:

Title Acronym:

Other Ids:

•233AS101

•2015-004098-33


•Drug: BIIB067

•Other: Placebo

Study Type:

Interventional

Phase:

Phase 1

Study Design:





Outcome Measures:

•Number of participantsexperiencing AdverseEvents (AEs) and SeriousAdverse Events (SAEs)

•Number of participantswith clinically significantlaboratory assessmentabnormalities

•Number of participants withclinically significant vitalsign abnormalities

•Number of participantswith clinically significantphysical examinationabnormalities

•Number of participantswith clinically significantneurological examinationabnormalities

•Number of participants withclinically significant 12-leadelectrocardiograms (ECGs)abnormalities

•PK parameter of BIIB067in plasma: Maximumobserved concentration(Cmax)

•PK parameter of BIIB067in plasma: Time to reachmaximum observedconcentration (Tmax)

•PK parameter of BIIB067in plasma: Area under theconcentration-time curvefrom time zero to infinity(AUCinf)

•PK parameter of BIIB067in plasma: Area under theconcentration-time curvefrom time zero to the timeof the last measurableconcentration (AUClast)

•and 3 more

Enrollment:

84

Age:


Sex:

All

•Biogen

•IonisPharmaceuticals,Inc.


January 31, 2016

Primary Completion:

February 2, 2019

Study Completion:

February 2, 2019

First Posted:

December 8, 2015


No Results Posted

Last Update Posted:

June 1, 2018


•University of California SanDiego Medical Center, La Jolla,California, United States


•Compass Research, LLC,Orlando, Florida, United States

•The Emory Clinic, Atlanta,Georgia, United States


•Massachusetts GeneralHospital, MA, Boston,Massachusetts, United States

•Washington University Schoolof Medicine, Saint Louis,Missouri, United States

•Volunteer Research Group,LLC, Knoxville, Tennessee,United States

•UZ Leuven, Leuven, Belgium

•and 7 more





- Page 39 of 56 -


FunderType

Dates Locations

53 NCT02611674 Methodology Study of NovelOutcome Measures to AssessProgression of ALS

Study Documents:

Title Acronym:

Other Ids:

999AS003



Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Longitudinal standardizedmean change inelectrophysiologicalmeasures as assessedby electrical impedancemyography (EIM)

•Longitudinal standardizedmean change inelectrophysiologicalmeasures as assessed bycompound muscle actionpotential (CMAP)

•Longitudinal standardizedmean change inelectrophysiologicalmeasures as assessedby motor unit numberestimation (MUNE)

•Longitudinal standardizedmean change inelectrophysiologicalmeasures as assessed bymotor unit number index(MUNIX)

•Longitudinal standardizedmean change in musclestrength measures asassessed by hand-helddynamometry (HHD)

•Longitudinal standardizedmean change in respiratorymeasures as assessed byslow vital capacity (SVC)

•Longitudinal standardizedmean change in functionalmeasures as assessedby Amyotrophic LateralSclerosis Functional RatingScale-Revised (ALSFRS-R)

•Within-participanttest-retest reliabilitybetween the 2 repeatedmeasurements occurringon Day 1 and Day 7 forEIM

•Within-participanttest-retest reliabilitybetween the 2 repeatedmeasurements for CMAP

•Within-participanttest-retest reliabilitybetween the 2 repeatedmeasurements for MUNE

•and 9 more

Enrollment:

100

Age:

16 Years to 85Years (Child,Adult, Older Adult)

Sex:

All

•Biogen •Industry Study Start:

January 6, 2016

Primary Completion:

August 2, 2019

Study Completion:

August 2, 2019

First Posted:

November 23, 2015


No Results Posted

Last Update Posted:

August 8, 2018

•University of California SanDiego Medical Center, SanDiego, California, United States



•The Emory Clinic, Atlanta,Georgia, United States


•Massachusetts GeneralHospital, MA, Charlestown,Massachusetts, United States


•Penn State Milton S. HersheyMedical Center, Hershey,Pennsylvania, United States

•UZ Leuven, Leuven, Belgium

•Sunnybrook Health SciencesCentre, Toronto, Ontario,Canada

•and 11 more




- Page 40 of 56 -


FunderType

Dates Locations

54 NCT02574390 Answer ALS: IndividualizedInitiative for ALS Discovery

Study Documents:

Title Acronym:

AnswerALS

Other Ids:

IRB00082277



•Flail Arm ALS


•MonomelicAmyotrophy


•Asymptomatic ALSGene Carriers

•Healthy Controls

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•ALS Functional RatingScale-Revised (ALSFRS-R)

•ALS Cognitive BehavioralScale (ALS-CBS)

•Slow Vital Capacity (SVC)

•Strength Testing with HandHeld Dynamometer (HHD)

Enrollment:

1000

Age:


Sex:

All

•Johns HopkinsUniversity


•Emory University

•Ohio StateUniversity



•University ofCalifornia, Irvine

•MassachusettsInstitute ofTechnology

•New YorkGenome Center

•LeandroP. RizzutoFoundation

•Texas Neurology

•NorthwesternUniversity LesTurner ALSCenter


December 2015

Primary Completion:

January 2019

Study Completion:

July 2019

First Posted:

October 12, 2015


No Results Posted

Last Update Posted:

May 15, 2018


•Emory University, Atlanta,Georgia, United States

•Northwestern UniversityFeinberg School of Medicine,Chicago, Illinois, United States

•Johns Hopkins University,Baltimore, Maryland, UnitedStates



•Ohio State University WexnerMedical Center, Columbus,Ohio, United States

•Texas Neurology, Dallas,Texas, United States

55 NCT02567136 Imaging Biomarkers in ALS

Study Documents:

Title Acronym:

Other Ids:

130126




Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Imaging biomarkers

Enrollment:

30

Age:


Sex:

All

•University ofMinnesota -Clinical andTranslationalScience Institute


September 2015

Primary Completion:

September 2025

Study Completion:

September 2025

First Posted:

October 2, 2015


No Results Posted

Last Update Posted:

May 7, 2018





- Page 41 of 56 -


FunderType

Dates Locations

56 NCT02559869 Imaging and BioFluidBiomarkers in AmyotrophicLateral Sclerosis

Study Documents:

Title Acronym:

TRACK-ALS

Other Ids:

2015P000140


•Drug: [18F] GE-180 Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Measure & localize braininflammation in people withALS via [18F] GE-180 PETimaging.

•Define anatomical,structural, and functionalchanges in the brain viaMRI of ALS Subjectsvs. Healthy Controls atBaseline

•Determine systemicinflammatory factorsthat may modify theprogression or otherclinical or imagingcorrelates of ALS.

•Determine the longitudinalchanges in braininflammation in peoplewith ALS in correlation withALS severity and rate ofprogression.

•Determine the longitudinalchanges in the anatomical,structural, and functionalmeasures in peoplewith ALS, and build ALSprediction models usingthe clinical and MRI data.

Enrollment:

200

Age:


Sex:

All


•The MethodistHospital System


•ALS Association


November 2015

Primary Completion:

January 2020

Study Completion:

May 2021

First Posted:

September 24, 2015


No Results Posted

Last Update Posted:

March 23, 2018


•Houston Methodist Hospital,Houston, Texas, United States




- Page 42 of 56 -


FunderType

Dates Locations

57 NCT02532244 Genetics of Pediatric-Onset Motor Neuron andNeuromuscular Diseases

Study Documents:

Title Acronym:

Other Ids:

764456

Recruiting •Spinal MuscularAtrophy

•Charcot-Marie-Tooth Disease

•Muscular Dystrophy

•Spinal MuscularAtrophy WithRespiratoryDistress 1



•NeuromuscularDisease

•Peroneal MuscularAtrophy

•Fragile X Syndrome

•Other: samplecollection

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•genetic diagnosis

•SMN1 copy number

•SMN2 copy number

•target gene mRNA levels

•target gene protein levels

Enrollment:

300

Age:

6 Months and older (Child, Adult,Older Adult)

Sex:

All

•NemoursChildren's Clinic


June 2015

Primary Completion:

December 2022

Study Completion:

December 2022

First Posted:

August 25, 2015


No Results Posted

Last Update Posted:

August 25, 2015

•Alfred I. duPont Hospitalfor Children, Wilmington,Delaware, United States

•Nemours Children'sSpecialty Care, Jacksonville,Jacksonville, Florida, UnitedStates

•Nemours Children's Hospital,Orlando, Florida, United States

58 NCT02469675 Brain and Nerve Stimulation forHand Muscles in Spinal CordInjury and ALS

Study Documents:

Title Acronym:

Other Ids:

HAR-15-001

Recruiting •Spinal Cord Injury(SCI)


•Device:Transcranialmagneticstimulation

•Device: Mediannerve stimulation

•Device: Cervicaltranscutaneousstimulation

Study Type:

Interventional

Phase:

Not Applicable

Study Design:




Outcome Measures:

•Change in motor evokedpotential (MEP) amplitudeof the abductor pollicisbrevis (APB) muscleresponse to single pulsesof TMS

•Hand dexterity

•Safety and tolerability

•Grip strength

•Change in the duration ofthe 'cortical silent period'after TMS stimulationduring APB contraction

•F-wave responses of theAPB muscle

Enrollment:

30

Age:


Sex:

All

•Bronx VAMedical Center

•U.S.Fed

Study Start:

June 2015

Primary Completion:

March 31, 2018

Study Completion:

March 31, 2018

First Posted:

June 11, 2015


No Results Posted

Last Update Posted:

January 30, 2018

•James J. Peters VA MedicalCenter, Bronx, NY, Bronx, NewYork, United States







- Page 43 of 56 -


FunderType

Dates Locations

59 NCT02437110 HERV-K Suppression UsingAntiretroviral Therapy inVolunteers With AmyotrophicLateral Sclerosis (ALS)

Study Documents:

Title Acronym:

Other Ids:

•150126

•15-N-0126



•Drug: Darunavir

•Drug: Ritonavir

•Drug: Raltegravir

•Drug: Zidovudine

Study Type:

Interventional

Phase:

Phase 1

Study Design:




Outcome Measures:

•The proportion ofparticipants with anundetectable HERV-K gagRNA level by quantitativePCR within 24 weeks ofstarting an antiretroviralregimen of darunavir,ritonavir, raltegravir, andzidovudine

•Safety and feasibility of upto 24 weeks of darunavir,ritonavir, raltegravir, andzidovudine for patients withALS

•The proportion ofparticipants with anundetectable HERV-Kenv or pol RNA level byquantitative PCR within24 weeks of starting anantiretroviral regimenof darunavir, ritonavir,raltegravir, and zidovudine

Enrollment:

20

Age:


Sex:

All



•NIH Study Start:

April 23, 2015

Primary Completion:

December 31, 2018

Study Completion:

December 31, 2018

First Posted:

May 7, 2015


No Results Posted

Last Update Posted:

August 9, 2018

•National Institutes of HealthClinical Center, 9000 RockvillePike, Bethesda, Maryland,United States





- Page 44 of 56 -


FunderType

Dates Locations

60 NCT02414230 F 18 T807 Tau PET Imagingin Familial Amyotrophic LateralSclerosis

Study Documents:

Title Acronym:

T807ALS

Other Ids:

IND 123119Protocol B



•Drug: Drug: F 18T807

Study Type:

Interventional

Phase:

Phase 2

Study Design:



•Primary Purpose:Diagnostic

Outcome Measures:

F 18 T807 Standard UptakeValue Ratios (SUVR) willbe correlated with otherimaging modalities (MRI,PET amyloid imaging) andcognitive performance.

Enrollment:

9

Age:


Sex:

All



February 2015

Primary Completion:

March 2020

Study Completion:

September 2020

First Posted:

April 10, 2015


No Results Posted

Last Update Posted:

July 2, 2018


61 NCT02374606 Accurate Test of Limb IsometricStrength (ATLIS) in ALS

Study Documents:

Title Acronym:

Other Ids:

Pro00038868


Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Change in Accurate Testof Limb Isometric Strength(ATLIS) between each visit

•Change in ALS FunctionalRating Scale - Revised(ALSFRS-R) between eachvisit

Enrollment:

100

Age:


Sex:

All



March 2015

Primary Completion:

February 2020

Study Completion:

February 2020

First Posted:

March 2, 2015


No Results Posted

Last Update Posted:

April 3, 2018







- Page 45 of 56 -


FunderType

Dates Locations

62 NCT02365922 Advancing Research andTreatment for FrontotemporalLobar Degeneration (ARTFL)

Study Documents:

Title Acronym:

ARTFL

Other Ids:

•ARTFL8101

•1U54NS092089-01

Recruiting •FTLD

•ProgressiveSupranuclear Palsy(PSP)

•FrontotemporalDementia (FTD)

•CorticobasalDegeneration(CBD)

•PPA Syndrome

•Behavioral VariantFrontotemporalDementia (bvFTD)

•SemanticVariant PrimaryProgressiveAphasia (svPPA)

•NonfluentVariant PrimaryProgressiveAphasia (nfvPPA)

•FTD WithAmyotrophicLateral Sclerosis(FTD/ALS)


•OligosymptomaticPSP (oPSP)

•CorticobasalSyndrome (CBS)

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Scores of UDS FTLDModule Tests

•Progressive SupranuclearPalsy Rating Scale(PSPRS)

•Neuroimaging

Enrollment:

1560

Age:


Sex:

All

•University ofCalifornia, SanFrancisco



•The BluefieldProject

•Tau Consortium

•Other

•NIH

Study Start:

September 2014

Primary Completion:

September 2020

Study Completion:

February 2021

First Posted:

February 19, 2015


No Results Posted

Last Update Posted:

May 4, 2018

•University of Alabama,Birmingham, Alabama, UnitedStates

•University of California,Los Angeles, Los Angeles,California, United States

•University of California, SanDiego, San Diego, California,United States

•University of California, SanFrancisco, San Francisco,California, United States

•Mayo Clinic - Jacksonville,Jacksonville, Florida, UnitedStates

•Northwestern University,Chicago, Illinois, United States

•Johns Hopkins University,Baltimore, Maryland, UnitedStates

•Harvard UniversityMassachusetts GeneralHospital, Charlestown,Massachusetts, United States

•Mayo Clinic - Rochester,Rochester, Minnesota, UnitedStates

•Washington University, SaintLouis, Missouri, United States

•and 8 more




- Page 46 of 56 -


FunderType

Dates Locations

63 NCT02327845 Phenotype, Genotype &Biomarkers in ALS and RelatedDisorders

Study Documents:

Title Acronym:

Other Ids:

U54NS092091


•FrontotemporalDementia


•Hereditary SpasticParaplegia


•MultisystemProteinopathy

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Phenotypic correlates ofgenotype

•Genetic determinants ofphenotype

Enrollment:

700

Age:


Sex:

All




•St. JudeChildren'sResearchHospital

•ALS Association

•Other

•NIH

Study Start:

April 2015

Primary Completion:

August 2019

Study Completion:

August 2019

First Posted:

December 30, 2014


No Results Posted

Last Update Posted:

January 23, 2018

•Stanford University, Palo Alto,California, United States

•University of California SanDiego (UCSD), San Diego,California, United States

•California Pacific MedicalCenter (CPMC), San Francisco,California, United States


•University of Iowa, Iowa City,Iowa, United States

•Kansas University MedicalCenter (KUMC), Kansas City,Kansas, United States

•Twin Cities ALS ResearchConsortium, Minneapolis,Minnesota, United States

•Wake Forest University,Winston-Salem, North Carolina,United States

•Cleveland Clinic, Cleveland,Ohio, United States

•University of Pennsylvania,Philadelphia, Pennsylvania,United States

•and 6 more

64 NCT02228915 Analysis of Post-TranslationalModifications of a Critical ProteinImplicated in AmyotrophicLateral Sclerosis

Study Documents:

Title Acronym:

SOD1

Other Ids:

14-1780

Recruiting •ALS Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Post-translationalmodifications (PTMs) of Cu/Zn superoxide dismutase 1

Enrollment:

30

Age:


Sex:

All

•University ofNorth Carolina,Chapel Hill


August 2014

Primary Completion:

August 2018

Study Completion:

August 2018

First Posted:

August 29, 2014


No Results Posted

Last Update Posted:

November 14, 2017

•UNC Neurology ALS clinic,Chapel Hill, North Carolina,United States








- Page 47 of 56 -


FunderType

Dates Locations

65 NCT02118727 Therapy in Amyotrophic LateralSclerosis With Memantine at 20mg BID (TAME)

Study Documents:

Title Acronym:

TAME

Other Ids:

•TAME-ALSFD003937-01

•FDA

Not yetrecruiting


•Frontal TemporalDementia

•Drug: Memantine

•Drug: Placebo (forMemantine)

Study Type:

Interventional

Phase:

Phase 2

Study Design:





Outcome Measures:

•Disease progression asmeasured by the numberof points lost on the ALSFunctional Rating-Scale-Revised (ALSFRS-R)

•Measuring the levels ofTau, pNFH and the pNFH/C3 ratio in CSF and blood

Enrollment:

90

Age:


Sex:

All



March 2018

Primary Completion:

October 2021

Study Completion:

October 2021

First Posted:

April 21, 2014


No Results Posted

Last Update Posted:

February 21, 2018

•Phoenix NeurologicalAssociates, Phoenix, Arizona,United States

•UC Irvine, Irvine, California,United States


•University of Washington,Seattle, Washington, UnitedStates




- Page 48 of 56 -


FunderType

Dates Locations

66 NCT02118805 Innovative Measures of Speechand Swallowing Dysfunction inNeurological Disorders

Study Documents:

Title Acronym:

QUESST

Other Ids:

2013P000204


•Myasthenia Gravis

•Myopathies

•Stroke


Study Type:

Observational

Phase:

Study Design:

•Observational Model:Other


Outcome Measures:

•Change in Muscle Healthover 18 months byStandard Ultrasound

•Change in Score onthe Sydney SwallowQuestionnaire (over 18months)

•Change in Number ofSeconds It takes to RepeatIndividual Words TenTimes (over 18 months)

•Change in Number ofSeconds It Takes toSwallow of 3 ounces ofWater (over 18 months)

•Change in Score on theAmyotrophic LateralSclerosis Rating Scale -Revised (ALSFRS-R) (over18 months)

•Change in Score on theQuantitative MyastheniaGravis Scale (over 18months)

•Change in Score onthe United Parkinson'sDisease Rating Scale(UPDRS) (over 18 months)

•Change in Muscle Healthby Standard ConcentricNeedle Electromyography(EMG) (over 18 months)

•Change in Muscle Healthby Specialized ElectricalImpedance Arrays

Enrollment:

200

Age:


Sex:

All



October 2013

Primary Completion:

June 2018

Study Completion:

June 2019

First Posted:

April 21, 2014


No Results Posted

Last Update Posted:

March 5, 2018





- Page 49 of 56 -


FunderType

Dates Locations

67 NCT02104921 Innovative UltrasoundTechnology in NeuromuscularDisease

Study Documents:

Title Acronym:

AQUIRe

Other Ids:

•2012P000364

•2K24NS060951



•Radiculopathy

•Myopathy

•PolyneuropathyandMononeuropathies

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Quantitative ultrasounddata, including quantifiedgrayscale data andbackscattered acoustic data

Enrollment:

240

Age:


Sex:

All



•Other

•NIH

Study Start:

December 2013

Primary Completion:

July 2018

Study Completion:

July 2019

First Posted:

April 7, 2014


No Results Posted

Last Update Posted:

March 5, 2018


68 NCT02014246 Genetic Characterization ofMovement Disorders andDementias

Study Documents:

Title Acronym:

Other Ids:

•999903329

•03-AG-N329

Recruiting •Ataxia

•Dystonia



•CorticobasalDegeneration

•Multiple SystemAtrophy

•Alzheimer'sDisease

•Lewy BodyDementia

•Parkinson Disease-Dementia

•Dentatorubral-pallidoluysianAtrophy

•and 5 more

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Identify and characterizegenetic contributions toetiology for movementdisorders, such as dystonia,Parkinson's disease,and dementias, suchas Alzheimer's disease,Lewy Body Dementia,frontotemporal dementia.

Enrollment:

12000

Age:


Sex:

All

•National Instituteon Aging (NIA)


•NIH Study Start:

February 12, 2003

Primary Completion:

December 31, 2018

Study Completion:

December 31, 2018

First Posted:

December 18, 2013


No Results Posted

Last Update Posted:

August 9, 2018

•National Institute of Aging,Clinical Research Unit,Baltimore, Maryland, UnitedStates







- Page 50 of 56 -


FunderType

Dates Locations

69 NCT01938495 Diaphragm Pacing System(DPS) In Participants WithAmyotrophic Lateral Sclerosis(ALS)

Study Documents:

Title Acronym:

DPS in ALS

Other Ids:

2013P001504



•Device: NeuRx®Diaphragm PacingSystem™ (DPS)

Study Type:

Interventional

Phase:

Phase 2

Study Design:





Outcome Measures:

•Survival

•quality of life

Enrollment:

52

Age:


Sex:

All

•BarrowNeurologicalInstitute

•ALS Association

•MuscularDystrophyAssociation

•SynapseBiomedical

•Other

•Industry

Study Start:

August 2013

Primary Completion:

January 2017

Study Completion:

April 2017

First Posted:

September 10, 2013


No Results Posted

Last Update Posted:

December 23, 2016



•California Pacific MedicalCenter, San Diego, California,United States

•Stanford University, Stanford,California, United States


•Mayo Clinic Florida,Jacksonville, Florida, UnitedStates

•University of Florida,Jacksonville, Jacksonville,Florida, United States

•University of Iowa, Iowa City,Iowa, United States


•Henry Ford Health Systems,Detroit, Michigan, United States

•and 15 more

70 NCT01931644 Be the Bridge BetweenResearchers and a Cure(GVHD, ALS, Hepatitis B,Alzheimer's Disease, Leukemia,and More)

Study Documents:

Title Acronym:

Other Ids:

SAN-BB-01

Recruiting •All DiagnosedHealth Conditions

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Biospecimen & Clinical DataCollection

Enrollment:

20000

Age:


Sex:

All

•SanguineBiosciences


July 2013

Primary Completion:

August 2020

Study Completion:

December 2040

First Posted:

August 29, 2013


No Results Posted

Last Update Posted:

April 18, 2018

•Sanguine Biosciences, LosAngeles, California, UnitedStates










- Page 51 of 56 -


FunderType

Dates Locations

71 NCT01925196 Natural History and Biomarkersof Amyotrophic Lateral Sclerosisand Frontotemporal DementiaCaused by the C9ORF72 GeneMutation

Study Documents:

Title Acronym:

Other Ids:

•130188

•13-N-0188



•FrontotemporalLobar Degeneration

Study Type:

Observational

Phase:

Study Design:

Time Perspective:Prospective

Outcome Measures:

•ALS Functional RatingScale-revised

•Frontobehavioral Index

•Verbal Fluency Score

Enrollment:

48

Age:


Sex:

All


•National Instituteon Aging (NIA)


•NIH Study Start:

August 15, 2013

Primary Completion:

September 10, 2018

Study Completion:

September 10, 2018

First Posted:

August 19, 2013


No Results Posted

Last Update Posted:

August 9, 2018


72 NCT01786603 Rasagiline in Subjects WithAmyotrophic Lateral Sclerosis(ALS)

Study Documents:

Title Acronym:

Other Ids:

•12312

•R01FD003739



•Drug: Rasagiline

•Drug: Placebo

Study Type:

Interventional

Phase:

Phase 2

Study Design:


•Intervention Model:Crossover Assignment

•Masking: Triple(Participant, Care Provider,Investigator)


Outcome Measures:

•Change in the ALSFunctional Rating Scale-Revised (ALSFRS-R)

•Change in vital capacity(VC)

•Change in quality of life

•Number of participants withadverse events

•Difference in survivalstatus between studygroups

•Bcl2Bax expression ratio inRNA samples

•Biomarker Assays ofMitochondrial Function

•Effect of study drug onapoptosis markers

•Effect of study drug onoxidative stress

Enrollment:

80

Age:


Sex:

All

•Richard Barohn,MD



September 2012

Primary Completion:

August 2017

Study Completion:

August 2017

First Posted:

February 8, 2013


No Results Posted

Last Update Posted:

June 14, 2017

•Phoenix NeurologicalAssociates, Phoenix, Arizona,United States

•University of California - Irvine,Irvine, California, United States



•St. Louis University, SaintLouis, Missouri, United States

•University of Nebraska,Omaha, Nebraska, UnitedStates

•Columbia University, New York,New York, United States

•Oregon Health and ScienceUniversity, Portland, Oregon,United States

•University of Pennsylvania,Philadelphia, Pennsylvania,United States

•UT Southwestern MedicalCenter, Dallas, Texas, UnitedStates









- Page 52 of 56 -


FunderType

Dates Locations

73 NCT01772602 The National AmyotrophicLateral Sclerosis Registry

Study Documents:

Title Acronym:

Other Ids:

CDC-NCEH/ATSDR-5768


Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•The National AmyotrophicLateral Sclerosis (ALS)Registry

•Risk factors of ALS

Enrollment:

16000

Age:


Sex:

All

•Centers forDisease Controland Prevention


•Centers forMedicareand MedicaidServices

•U.S.Fed

Study Start:

October 2010

Primary Completion:

December 2022

Study Completion:

December 2022

First Posted:

January 21, 2013


No Results Posted

Last Update Posted:

February 14, 2018

•CDC, Atlanta, Georgia, UnitedStates

74 NCT01699451 DNA, Blood and Skin CellRepository for Research on ALSand Related NeurodegenerativeDisorders at Mayo Clinic Florida

Study Documents:

Title Acronym:

Other Ids:

12-004718



Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Repository samplecollection

Enrollment:

160

Age:


Sex:

All

•Mayo Clinic •Other Study Start:

September 2012

Primary Completion:

December 2019

Study Completion:

December 2019

First Posted:

October 3, 2012


No Results Posted

Last Update Posted:

March 22, 2018

•Mayo Clinic Florida,Jacksonville, Florida, UnitedStates







- Page 53 of 56 -


FunderType

Dates Locations

75 NCT01609283 A Dose-escalation Safety Trialfor Intrathecal AutologousMesenchymal Stem CellTherapy in Amyotrophic LateralSclerosis

Study Documents:

Title Acronym:

Other Ids:

11-008415



•Biological:autologousmesenchymal stemcells

Study Type:

Interventional

Phase:

Phase 1

Study Design:




Outcome Measures:

•Number of patients withdose-limiting toxicities

•Number of patients withadverse events

•Change in serumsedimentation rate

•Change in C-reactiveprotein levels

•Change in complete bloodcounts

•Change in total nucleatedcell count in cerebrospinalfluid (CSF)

•Change in protein level incerebrospinal fluid (CSF)

•Number of patients withpresence of cancer cellsin their cerebrospinal fluid(CSF)

Enrollment:

27

Age:


Sex:

All

•Mayo Clinic •Other Study Start:

May 2012

Primary Completion:

April 2018

Study Completion:

April 2018

First Posted:

May 31, 2012


No Results Posted

Last Update Posted:

January 12, 2018

•Mayo Clinic, Rochester,Minnesota, United States

76 NCT01508962 PRE-Symptomatic Studies inAmyotrophic Lateral Sclerosis

Study Documents:

Title Acronym:

PRESS-ALS

Other Ids:

PRESS-ALS



Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Phenoconversion

Enrollment:

100

Age:


Sex:

All



November 2013

Primary Completion:

December 2027

Study Completion:

December 2027

First Posted:

January 12, 2012


No Results Posted

Last Update Posted:

June 19, 2018









- Page 54 of 56 -


FunderType

Dates Locations

77 NCT01459302 Genetic Study of Familial andSporadic ALS/Motor NeuronDisease, Miyoshi Myopathy andOther Neuromuscular Disorders

Study Documents:

Title Acronym:

Other Ids:

•H-13019

•5RC2NS070342-02


•FrontotemporalDementia

•PLS


•Lou GehrigsDisease

•Familial Disease

•AmyotrophicLateral Sclerosis,Sporadic


•Miyoshi Myopathy

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

identification of new genesthat may contribute to ALS

Enrollment:

6000

Age:


Sex:

All

•University ofMassachusetts,Worcester


•Other

•NIH

Study Start:

January 2009

Primary Completion:

October 2018

Study Completion:

October 2018

First Posted:

October 25, 2011


No Results Posted

Last Update Posted:

August 31, 2017

•University of MassachusettsMedical School, Worcester,Massachusetts, United States

78 NCT00912041 BrainGate2: Feasibility Study ofan Intracortical Neural InterfaceSystem for Persons WithTetraplegia

Study Documents:

Title Acronym:

BrainGate2

Other Ids:

•MGH-BG2-TP-001

•R01DC009899

•1UH2NS095548

Recruiting •Tetraplegia

•Spinal Cord Injuries


•Brain StemInfarctions

•Locked inSyndrome


•Device: Placementof the BrainGate2sensor(s) intothe motor-relatedcortex

Study Type:

Interventional

Phase:

Not Applicable

Study Design:




Outcome Measures:

•The primary endpointof this Study is todetermine the safety ofthe BrainGate2 NeuralInterface System.

•To investigate thefeasibility of BrainGate2and to establish theparameters for a largerclinical study, suchas appropriate neuraldecoding algorithms,sample size, indices ofmeasurement, successcriteria, and endpoints.

Enrollment:

15

Age:


Sex:

All

•Leigh R.Hochberg, MD,PhD.





•Other

•NIH

•U.S.Fed

Study Start:

May 2009

Primary Completion:

September 2021

Study Completion:

December 2021

First Posted:

June 3, 2009


No Results Posted

Last Update Posted:

March 29, 2018

•Stanford University School ofMedicine, Stanford, California,United States


•Case Western ReserveUniversity, Cleveland, Ohio,United States

•Providence VA Medical Center,Providence, Rhode Island,United States









- Page 55 of 56 -


FunderType

Dates Locations

79 NCT00821132 Genetics of Familial andSporadic ALS

Study Documents:

Title Acronym:

ALS

Other Ids:

•Lab01

•RO1N505641-04


•FamilialAmyotrophicLateral Sclerosis

•AmyotrophicLateralSclerosis WithFrontotemporalDementia

•Lou Gehrig'sDisease



•Other: Geneticstudy of ALSfamilies

Study Type:

Observational

Phase:

Study Design:

•Observational Model:Family-Based


Outcome Measures:

Identification of genes thatincrease risk for sporadicALS or cause inherited ALS.

Enrollment:

15000

Age:


Sex:

All

•NorthwesternUniversity


January 1991

Primary Completion:

December 2019

Study Completion:

December 2022

First Posted:

January 13, 2009


No Results Posted

Last Update Posted:

March 29, 2018

•Northwestern UniversityFeinberg School of Medicine,Chicago, Illinois, United States

80 NCT00317616 The Pre-symptomatic FamilialAmyotrophic Lateral Sclerosis(Pre-fALS) Study

Study Documents:

Title Acronym:

Pre-fALS

Other Ids:

Pre-fALS


Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Risk Factors forProgression to familial ALS

Enrollment:

500

Age:


Sex:

All


•ALS Association


April 2006

Primary Completion:

December 2027

Study Completion:

December 2027

First Posted:

April 25, 2006


No Results Posted

Last Update Posted:

June 19, 2018


81 NCT00136500 Clinical Research in ALS Study

Study Documents:

Title Acronym:

CRiALS

Other Ids:

FALS feasibility


Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Recruitment

Enrollment:

10000

Age:


Sex:

All

•Michael Benatar

•ALS Association

•ALS RecoveryFund



February 2005

Primary Completion:

December 2027

Study Completion:

December 2027

First Posted:

August 29, 2005


No Results Posted

Last Update Posted:

June 19, 2018








- Page 56 of 56 -


FunderType

Dates Locations

82 NCT00015444 Screening and Natural History:Primary Lateral Sclerosis andRelated Disorders

Study Documents:

Title Acronym:

Other Ids:

•010145

•01-N-0145



Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

The primary outcome of thisprotocol is to document thenatural history of clinicalprogression in PLS, definedas the change in clinicalmeasures of movementspeed over time: fingertapping, timed gait, and timeto read a standard passage.

Enrollment:

189

Age:


Sex:

All



•NIH Study Start:

May 1, 2001

Primary Completion:

Study Completion:

First Posted:

April 19, 2001


No Results Posted

Last Update Posted:

August 9, 2018


U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services


