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ONGOING CLINICAL TRIALSONGOING CLINICAL TRIALS
University of VermontUniversity of VermontPresented by: Rup Tandan, MD, FRCPPresented by: Rup Tandan, MD, FRCP
TRIAL OF HIGH FAT / HIGH CALORIE TRIAL OF HIGH FAT / HIGH CALORIE DIET IN ALSDIET IN ALS
PI: PI: Rup Tandan, MD
Supported By: Supported By: Muscular Dystrophy Association
Objectives: Objectives: To compare the safety and tolerability in three subject
groups randomized to high fat/high calorie, high calorie or control diets
To measure biomarkers of body composition and lipid metabolism before and during diet intervention
To examine preliminary effects of the three diets on measures of disease progression
Enrollment closes 10/31/12
ALS RESEARCH GROUPALS RESEARCH GROUPDNA BANKING STUDYDNA BANKING STUDY
PI: PI: Rup Tandan, MD
Supported By: Supported By: The National Institutes of Health (NIH),
the Muscular Dystrophy Association, and the
Amyotrophic Lateral Sclerosis Association (ALSA)
Objectives: Objectives: To look at genetic factors that may contribute to the development of ALS and which may improve the genetic diagnosis of ALS and related Motor Neuron Diseases.
A MULTI-CENTER, SINGLE BLIND, RANDOMIZED A MULTI-CENTER, SINGLE BLIND, RANDOMIZED STUDY COMPARING THYMECTOMY TO NON STUDY COMPARING THYMECTOMY TO NON
THYMECTOMY IN NON-THYMOMATOUS MYASTHENIA THYMECTOMY IN NON-THYMOMATOUS MYASTHENIA GRAVIS (MG) PATIENTS RECEIVING PREDNISONEGRAVIS (MG) PATIENTS RECEIVING PREDNISONE
PI: PI: Rup Tandan, MD
Supported By:Supported By: The National Institutes of Neurological Disorders & Stroke (NINDS)
Objectives:Objectives: The main purpose of this research is to determine
whether thymectomy has a positive influence on the management of patients with myasthenia gravis who are taking prednisone and who do not have a thymoma. The project's ancillary Biomarkers study will evaluate genetic factors and gene and protein expression in the blood and thymus (in patients undergoing thymectomy) which may influence MG.
Enrollment closes in November 2012
CONTACT INFORMATION for CONTACT INFORMATION for Dr. Tandan’s StudiesDr. Tandan’s Studies
Rup Tandan, MD - Site PI
(802) 847-4589
Study Coordinator for Nutrition Study and Thymectomy Trial
(802) 656-4582
A MULTICENTER, DOUBLE-BLIND, PARALLEL GROUP, A MULTICENTER, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY OF CREATINE IN PLACEBO CONTROLLED STUDY OF CREATINE IN
SUBJECTS WITH TREATED PARKINSON’S DISEASE (PD).SUBJECTS WITH TREATED PARKINSON’S DISEASE (PD).LONG-TERM STUDY – 1 (LS-1)LONG-TERM STUDY – 1 (LS-1)
PI: PI: Robert Hamill, MD Supported By: Supported By: NIH, National Institute of Neurological
Disorders and Stroke (NINDS)
Objective:Objective:
To determine if there is a slowing of clinical decline in PD patients defined by a combination of cognitive, physical, and quality of life measures.
NET-PD LS-1NET-PD LS-1 1,720 subjects from approximately 52 US and Canadian
sites will be equally randomized to the study arms..
Main Inclusion CriteriaMain Inclusion Criteria Subject is willing and able to give informed consent and
commit to long-term follow-up PD within 5 years of diagnosis Treated/responsive to dopaminergic therapy (dopamine
agonists or levodopa) for at least 90 days, but not more than 2 years
Enrollment was closed as of May 2011.There are 27 active patients at our site.
A MULTICENTER, DOUBLE-BLIND, PLACEBO A MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PHASE II STUDY OF PIOGLITAZONE IN CONTROLLED, PHASE II STUDY OF PIOGLITAZONE IN
EARLY PARKINSON’S DISEASE (PD).EARLY PARKINSON’S DISEASE (PD).(FS-ZONE)(FS-ZONE)
PI:PI: James Boyd, MD Supported By: Supported By: NIH, National Institute of Neurological
Disorders and Stroke (NINDS)
Objective:Objective:To assess the impact of pioglitazone on the progression of PD in
order to determine whether it is futile to proceed with further study of this agent. The secondary objectives of the study are to collect additional efficacy and safety/tolerability data to be used in planning a subsequent Phase III trial of pioglitazone in early, treated PD.
NET-PD FS-ZONENET-PD FS-ZONE
Approximately 216 subjects from approximately 43 sites in the US will be enrolled in this study to assess the impact of two doses of pioglitazone on the clinical decline of PD.
Main Inclusion CriteriaMain Inclusion CriteriaSubject is willing and able to give informed consent and commit to 44 weeks of follow-upSubjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8 weeks but no more than 8 months
CONTACT INFORMATIONCONTACT INFORMATION
Robert Hamill, MD - Site PI
(802) [email protected]
Study Coordinator:
(802) [email protected]
EPILEPSY CLINICAL TRIALSEPILEPSY CLINICAL TRIALSCLOSED TO FURTHER ENROLLMENTCLOSED TO FURTHER ENROLLMENT
An Open-Label Extension Phase of the Double-blind, Placebo-controlled, Dose-escalation, Parallel-group Study of E2007 (perampanel) as an Adjunctive Therapy in Patients with Refractory Partial Seizures
An open-label, multinational, multicenter, follow-up study to evaluate the long-term safety and efficacy of brivaracetam, used at a flexible dose up to a maximum of 150 mg/day, in subjects aged 16 years or older suffering from epilepsy. .
THE MS CENTERTHE MS CENTEROF NORTHERN NEW ENGLAND AT OF NORTHERN NEW ENGLAND AT
UVM/FLETCHER ALLENUVM/FLETCHER ALLEN
Angela Applebee, MD – DirectorAngela Applebee, MD – DirectorAndrew Solomon, MDAndrew Solomon, MDSandra McGrath, RN FNPSandra McGrath, RN FNPPatty Krusinski, CCRC, Study CoordinatorPatty Krusinski, CCRC, Study CoordinatorAnneMarie Savage, RN, Research NurseAnneMarie Savage, RN, Research NurseJane Low, MPA, Study Coordinator Jane Low, MPA, Study Coordinator
ONGOING CLINICAL TRIALS IN MSONGOING CLINICAL TRIALS IN MSCLOSED TO FURTHER ENROLLMENTCLOSED TO FURTHER ENROLLMENT
Novartis 2306Novartis 2306
A double-blind, randomized, multicenter, placebo-controlled, parallel-group study evaluating safety and efficacy of 0.5mg FTY720 (fingolimod) in patients with PPMS
Novartis 2309Novartis 2309 A DB, PC RCT to examine safety and efficacy of 2 doses of
FTY720 (fingolimod) capsules in RRMS over 24 months..
Biogen Idec – Daclizumab Study in Relapsing-Remitting MS Biogen Idec – Daclizumab Study in Relapsing-Remitting MS
To determine the efficacy and safety of daclizumab high yield process (DAC HYP) versus Avonex® (Interferon β-1a) in patients with relapsing-remitting MS.
ADDITIONAL CLINICAL TRIALS IN MSADDITIONAL CLINICAL TRIALS IN MSCLOSED TO FURTHER ENROLLMENT CLOSED TO FURTHER ENROLLMENT (Continued)(Continued)
Extension Study AC-058B202Extension Study AC-058B202
Extension study to AC-058B201 to study long-term safety, tolerability and efficacy of 3 doses of ACT-128800 in RRMS
EFC6260 EFC6260 –– Sanofi-Aventis Sanofi-AventisInternational, multi-center, randomized, double-blind, placebo-
controlled, parallel-group study to evaluate efficacy and safety of teriflunomide in patients with a first clinical episode suggestive of MS.
ONGOING CLINICAL TRIALS IN MSONGOING CLINICAL TRIALS IN MSOPEN TO ENROLLMENTOPEN TO ENROLLMENT
Stratify Stratify –– 2 Biogen 2 BiogenJCV Anitbody program in patients with RRMS receiving or considering treatment with Tysabri
Genentech/Roche Ocrelizumab study in Relapsing MS Genentech/Roche Ocrelizumab study in Relapsing MS A multicenter, randomized trial to evaluate the safety and efficacy of ocrelizumab in comparision to interferon beta-1a (Rebif®) in patients with relapsing MS
Opexa Therapeutics, Inc. In Secondary Progressive MSOpexa Therapeutics, Inc. In Secondary Progressive MS A multicenter, double-blind trial to evaluate the safety and effectiveness of an investigational T-cell product when compared to placebo in patients with secondary progressive MS
STROKE/NEUROCRITICAL CARESTROKE/NEUROCRITICAL CAREIRISIRIS
(Insulin Resistance Intervention after Stroke)
PI: Mark Gorman, MDPI: Mark Gorman, MD
NINDS-funded multicenter randomized clinical secondary prevention trial
Looks at reduction of recurrent stroke, MI and death in insulin resistant stroke/TIA patients
Intervention is pioglitazone 45 mg (insulin sensitizer/PPAR- agonist) vs. placebo
Follow-up 3-5 years
IRIS STUDY IRIS STUDY Contact InformationContact Information
Study Coordinator:
802-656-8993
Principal Investigator:
ABBOTT PARKINSON’S STUDYABBOTT PARKINSON’S STUDY
PI: James Boyd, MDPI: James Boyd, MD
Study of levodopa/carbidopa intestinal gel vs. oral levodopa/carbidopa
For pts with advanced Parkinson’s, who experience motor fluctuations and 3 or more hours of “off” time daily, despite optimized levodopa treatment. Closed to enrollment in July 2011.
Pts who have had DBS or other surgery for Parkinson’s are not eligible
ABBOTT PARKINSON’S STUDYABBOTT PARKINSON’S STUDY (Continued)(Continued)
Levodopa/carbidopa intestinal gel is an approved therapy in Europe known as Duodopa. Under testing in U.S. for FDA approval.
Medication delivered through a PEG with jejunal extension tube, by continuous infusion pump pts wear 16 hrs per day.
Intended to stabilize dopamine levels and minimize motor fluctuations.
ABBOTT PARKINSON’S STUDY ABBOTT PARKINSON’S STUDY Contact InformationContact Information
Study Coordinator:
802-656-3878
Principal Investigator:
