To view videos of the children at baseline and after onabotulinumtoxinA treatment please follow the links below
Girl Baseline httpsvimeocom2920639122e2f236b16
Girl Week 8 httpsvimeocom292064448c160a01b48
Boy Baseline httpsvimeocom2920646274df87f9ea7
Boy Week 8 httpsvimeocom2920647954ed44475de
Efficacy and Safety of OnabotulinumtoxinAfor the Treatment of Pediatric Lower Limb Spasticity Primary ResultsHeakyung Kim1 Jill Meilahn2 Chengcheng Liu3 Henry G Chambers4 Emily McCusker5Rozalina Dimitrova5
1Columbia University Medical CenterNew York Presbyterian Hospital New York NY USA 2Marshfield Clinic Marshfield WI USA 3Allergan plc Madison NJ USA 4Rady Childrenrsquos Specialists of San Diego San Diego CA USA 5Allergan plc Irvine CA USA
This study was sponsored by Allergan plc Dublin Ireland Writing and editorial assistance was provided to the authors by Karen Pemberton PhD of Evidence Scientifi c Solutions Inc and funded by Allergan plc All authors met the ICMJE authorship criteria Neither honoraria nor payments were made for authorship Financial arrangements of the authors with companies whose products may be related to the present report are listed below as declared by the authors
HK has received grantresearch support from Allergan plc and Ipsen JM and HGC have no fi nancial disclosures to report CL EM and RD are employees and shareholders of Allergan plc
References1 Shamsoddini A et al Iran J Pediatr 201424(4)345ndash3512 Koman LA et al Lancet 2004363(9421)1619ndash16313 BOTOXreg (onabotulinumtoxinA) for injection for intramuscular
intradetrusor or intradermal use Irvine CA Allergan 20164 Bohannon RW and Smith MB Phys Ther 198767(2)206ndash2075 Guy W ECDEU Assessment Manual Rockville MD US
Department of Health Education and Welfare 19766 Ansari NN et al Brain Inj 201327(5)605ndash6127 Borg J et al J Rehabil Med 201143(1)15ndash22
IN
TRO
DU
CTI
ON
M
ETH
OD
S
EFFICACY AND SAFETY OF ONABOTULINUMTOXINA FOR THE TREATMENT OF PEDIATRIC LOWER LIMB SPASTICITYPRIMARY RESULTSHeakyung Kim1 Jill Meilahn2 Chengcheng Liu3 Henry G Chambers4
Emily McCusker5 Rozalina Dimitrova5
1Columbia University Medical CenterNew York Presbyterian Hospital New York NY USA 2Marshfi eld Clinic Marshfi eld WI USA 3Allergan plc Madison NJ USA 4Rady Childrens Specialists of San Diego San Diego CA USA 5Allergan plc Irvine CA USA
To obtain a PDF of this poster and to view videos of children at baseline and after onabotulinumtoxinA treatmentbull Scan the QR code
OR bull Visit wwwallergancongressposterscom550370Charges may apply No personal information is stored
Presented at TOXINS 2019 the 4th International Congress of the International Neurotoxin Association (INA) January 16ndash19 2019 Copenhagen Denmark
Backgroundbull Spasticity is a common
impairment in children with cerebral palsy impeding function worsening quality of life and causing pain12
bull The safety and effi cacy of onabotulinumtoxinA treatment have been established in adult patients with muscle spasticity3
Objectivebull To evaluate the safety and
effi cacy of onabotulinumtoxinA for lower limb spasticityhypertonia in children with cerebral palsy
IN
TRO
DU
CTI
ON
IN
TRO
DU
CTI
ON
IN
TRO
DU
CTI
ON
M
ETH
OD
S
MET
HO
DS
M
ETH
OD
S
DIS
CLO
SUR
ES
RES
ULT
S Baseline Demographics and Disease Characteristics bull Baseline demographics and disease characteristics were generally balanced
across treatment groups (Table 2)
Table 2 Baseline demographics and disease characteristics
Study Designbull Phase 3 randomized double-blind placebo-controlled study
(Clinicaltrialsgov identifi er NCT01603628) (Table 1 Figure 1)
Assessmentsbull Primary outcome measure
Change from baseline in Modifi ed Ashworth Scale (MAS)4
ankle score at weeks 4 and 6 (average change from baseline)bull Secondary outcome measures
Clinical Global Impression of Change (CGI)5
Change in Modifi ed Tardieu Scale6
Goal Attainment Score7
bull Other measures Edinburgh Visual Gait Score
bull Safety and tolerability of treatments were also assessed
Table 1 General overview of lower limb pediatric study
12 Weeks9631 2 4 5 7 8 10 11
Primary endpointAverage of
weeks 4 and 6
Randomization and treatment
Screening MAS ge2 of ankleOnabotulinumtoxinA 8 Ukg + PT
OnabotulinumtoxinA 4 Ukg + PT
Placebo + PT
MAS = Modifi ed Ashworth Scale PT = physical therapy
Figure 1 Study design
OnabotulinumtoxinA in conjunction with standardized physical therapy
was safe and effective in treating lower limb spasticity in pediatric patients
with cerebral palsy
Statistically signifi cant improvement in the primary and secondary outcomes was observed with
onabotulinumtoxinA over standardized physical therapy alone
The safety profi le of onabotulinumtoxinA was
similar to that with placebo and no new safety signals
were identifi ed
Patientsindication Spasticity in ankle
Medically stable monoplegic or hemiplegic children
Aged 2ndashlt17 years with spasticity due to cerebral palsy
Duration Double-blind 12-week trial
InterventionsOnabotulinumtoxinA 4 UkgOnabotulinumtoxinA 8 Ukg + Standardized physical therapyPlacebo
Muscle injection required
GastrocnemiusSoleusTibialis posterior
GastrocnemiusCalfmuscles
Soleus
Achilles tendon
OnabotA 8 Ukg(n=127)
OnabotA 4 Ukg(n=125)
Placebo (n=129)
Total (N=381)
Mean (SD) age y 67 (39) 64 (36) 67 (39) 66 (38)le6 n () 74 (583) 73 (584) 74 (574) 221 (580)gt6 n () 53 (417) 52 (416) 55 (426) 160 (420)
Male n () 70 (551) 67 (536) 69 (535) 206 (541)Race n ()
White 76 (598) 76 (608) 79 (612) 231 (606)Asian 42 (331) 35 (280) 37 (287) 114 (299)Other 9 (71) 14 (112) 13 (101) 36 (94)
Hemiplegia n ()a 110 (866) 109 (872) 110 (853) 329 (864)Mean (SD) MAS ankle derived score knee extendedb
35 (052) 35 (053) 35 (050)
GMFCS ndash E and R n ()Level 1 69 (539) 65 (516) 65 (508) 199 (518)Level 2 54 (422) 51 (405) 56 (438) 163 (422)Levels 3 and 4 5 (39) 10 (80) 7 (55) 22 (57)
aAll others had monoplegia bMAS scale was converted from a 0ndash4 to 1ndash5 scaleGMFCS ndash E and R = Gross Motor Function Classifi cation System ndash Expanded and Revised MAS = Modifi ed Ashworth Scale OnabotA = OnabotulinumtoxinA SD = standard deviation
Effi cacy Outcomesbull OnabotulinumtoxinA 8 Ukg and 4 Ukg reduced (improved) average MAS-ankle
scores at weeks 4 and 6 compared with baseline Compared with the placebo group the change in MAS-ankle scores from
baseline were signifi cantly improved for both onabotulinumtoxinA treatment groups (Figure 2)
bull OnabotulinumtoxinA 8 Ukg and 4 Ukg increased (improved) average CGI scores at weeks 4 and 6
The increase with the 8-Ukg dose was statistically signifi cant (Figure 3)
Figure 2 OnabotulinumtoxinA reduces spasticity over the standard of care physical therapy
Figure 3 OnabotulinumtoxinA improves CGI over the standard of care physical therapy
Statistically signifi cant vs placeboMAS = Modifi ed Ashworth Scale OnabotA = onabotulinumtoxinA
Statistically signifi cant vs placeboCGI = Clinical Global Impression of Change OnabotA = onabotulinumtoxinA
Impr
ovem
ent
-10
-08
-06
-04
-02
-14
-12
0
MA
S k
nee
exte
nded
m
ean
chan
ge fr
om b
asel
ine
OnabotA8 Ukg
OnabotA4 Ukg Placebo
P=010
P=033
Impr
ovem
ent
04
06
08
12
10
14
16
0
02
18
Mea
n C
GI
OnabotA8 Ukg
OnabotA4 Ukg
Placebo
P=023 P=229
bull Both doses of onabotulinumtoxinA demonstrated signifi cant reduction in muscle tone (MAS scores) from baseline throughout the course of the study compared with placebo (Figure 4A)
bull A greater treatment response (CGI as determined by the physician) was observed at weeks 2 4 and 6 with onabotulinumtoxinA compared with placebo (Figure 4B)
Figure 4 OnabotulinumtoxinA demonstrates sustained improvement in (A) MAS and (B) CGI
-08
-04
-02
-06
-12
-14
-10
0
MA
S ch
ange
from
bas
elin
e
0 2 8 10 12WeekA
64
OnabotA 8 UkgOnabotA 4 UkgPlacebo
Impr
ovem
ent
OnabotA 8 UkgOnabotA 4 UkgPlacebo
08
16
18
14
12
10
04
02
0
06
20
Mea
n C
GI s
core
0 2 108 12Week 64
Impr
ovem
ent
B
Safety and Tolerabilitybull The incidence of adverse events with onabotulinumtoxinA was
similar to that with placebo (Table 3)bull No new safety signals were identifi ed
Table 3 Safety and tolerability
AEs n ()OnabotA 8 Ukg
(n=128)OnabotA 4 Ukg
(n=126)All OnabotA
(n=254)Placebo (n=128)
Treatment-emergent AEs 56 (438) 54 (429) 110 (433) 63 (492)
SAEs 0 3 (24)a 3 (12) 4 (31)b
Treatment-related AEs 4 (31) 3 (24) 7 (28) 2 (16)
Treatment-related SAEs 0 0 0 0
Discontinued owing to AE 0 0 0 0
Deaths 0 0 0 0aSAEs included cardiac disorders (extrasystole and tachycardia) seizure and tonsillar hypertrophy bSAEs included gastroenteritis seizure (n=2) and radicular painAE = adverse event OnabotA = OnabotulinumtoxinA SAE = serious adverse event
bull With the knee extended both doses of onabotulinumtoxinA signifi cantly improved the dynamic component of spasticity (Figure 6)
Both doses of onabotulinumtoxinA improved fast motion angle (R1) and slow motion angle (R2) measures
bull Similar results were observed when the knee was fl exedbull In a subset of patients who completed the assessment
onabotulinumtoxinA 8 Ukg demonstrated statistically signifi cant improvement in Edinburgh Visual Gait Total Score at week 8 (Figure 7)
bull The photographs in Figure 8 show representative examples of the improvement in gait seen with onabotulintoxinA
Figure 6 OnabotulinumtoxinA reduces dynamic tone (MTS)
Figure 5 OnabotulinumtoxinA improves active and passivefunctional goal attainment
Statistically signifi cant vs placeboMTS = Modifi ed Tardieu Scale OnabotA = onabotulinumtoxinA R2-R1 = difference between slow motion angle (R2) and fast motion angle (R1)
Statistically signifi cant vs placeboOnabotA = onabotulinumtoxinA
-02
0
04
02
-06
-04
06
8Active Passive
12 8 12 Week
Exce
eds
expe
ctat
ion
Meetsexpectation
Less
than
expe
ctat
ion
P=005P=047
P=001
P=004
P=01
OnabotA 8 UkgOnabotA 4 UkgPlacebo
Goa
l atta
inm
ent
-9
-8
-5
-6
-7
-3
-4
-2
-1
0
MTS
ank
le s
core
chan
ge fr
om b
asel
ine
in R
2-R
1
2 4 6 8 12Week
Impr
ovem
ent
P=02
P=02
P=006
OnabotA 8 UkgOnabotA 4 UkgPlacebo
Figure 7 OnabotulinumtoxinA improves gait more than physical therapy alone
Figure 8 Photos representative of the improvements seen ingait following treatment with OnabotulinumtoxinA
Statistically signifi cant vs placeboOnabotA = onabotulinumtoxinA
MAS = Modifi ed Ashworth Scale OnabotA = onabotulinumtoxinA
-40
-25
-30
-35
-15
-20
-10
-05
0
Edin
burg
h vi
sual
gai
t tot
al s
core
chan
ge fr
om b
asel
ine
8 12Week
Impr
ovem
ent
P=018
OnabotA 8 Ukg (n=26)OnabotA 4 Ukg (n=20)Placebo (n=17)
A 2-year-old male MASbaseline=3 MASweek 8=1OnabotA 8 Ukg
Week 8BaselinePlease scan QR code below to view videos of these children
B 2-year-old female MASbaseline=3 MASweek 8=2OnabotA 4 Ukg
Week 8BaselinePlease scan QR code below to view videos of these children
bull OnabotulinumtoxinA 8 Ukg and 4 Ukg both demonstrated greater active (eg walking speed endurance balance improved gait) and passive (eg pain tolerance of orthotic devices reduction in care needs) goal achievements than placebo (Figure 5)
Statistically signifi cant vs placeboCGI = Clinical Global Impression of Change MAS = Modifi ed Ashworth Scale OnabotA = onabotulinumtoxinA
SUM
MA
RY
P337
This study was sponsored by Allergan plc Dublin Ireland Writing and editorial assistance was provided to the authors by Karen Pemberton PhD of Evidence Scientifi c Solutions Inc and funded by Allergan plc All authors met the ICMJE authorship criteria Neither honoraria nor payments were made for authorship Financial arrangements of the authors with companies whose products may be related to the present report are listed below as declared by the authors
HK has received grantresearch support from Allergan plc and Ipsen JM and HGC have no fi nancial disclosures to report CL EM and RD are employees and shareholders of Allergan plc
References1 Shamsoddini A et al Iran J Pediatr 201424(4)345ndash3512 Koman LA et al Lancet 2004363(9421)1619ndash16313 BOTOXreg (onabotulinumtoxinA) for injection for intramuscular
intradetrusor or intradermal use Irvine CA Allergan 20164 Bohannon RW and Smith MB Phys Ther 198767(2)206ndash2075 Guy W ECDEU Assessment Manual Rockville MD US
Department of Health Education and Welfare 19766 Ansari NN et al Brain Inj 201327(5)605ndash6127 Borg J et al J Rehabil Med 201143(1)15ndash22
IN
TRO
DU
CTI
ON
M
ETH
OD
S
EFFICACY AND SAFETY OF ONABOTULINUMTOXINA FOR THE TREATMENT OF PEDIATRIC LOWER LIMB SPASTICITYPRIMARY RESULTSHeakyung Kim1 Jill Meilahn2 Chengcheng Liu3 Henry G Chambers4
Emily McCusker5 Rozalina Dimitrova5
1Columbia University Medical CenterNew York Presbyterian Hospital New York NY USA 2Marshfi eld Clinic Marshfi eld WI USA 3Allergan plc Madison NJ USA 4Rady Childrens Specialists of San Diego San Diego CA USA 5Allergan plc Irvine CA USA
To obtain a PDF of this poster and to view videos of children at baseline and after onabotulinumtoxinA treatmentbull Scan the QR code
OR bull Visit wwwallergancongressposterscom550370Charges may apply No personal information is stored
Presented at TOXINS 2019 the 4th International Congress of the International Neurotoxin Association (INA) January 16ndash19 2019 Copenhagen Denmark
Backgroundbull Spasticity is a common
impairment in children with cerebral palsy impeding function worsening quality of life and causing pain12
bull The safety and effi cacy of onabotulinumtoxinA treatment have been established in adult patients with muscle spasticity3
Objectivebull To evaluate the safety and
effi cacy of onabotulinumtoxinA for lower limb spasticityhypertonia in children with cerebral palsy
IN
TRO
DU
CTI
ON
IN
TRO
DU
CTI
ON
IN
TRO
DU
CTI
ON
M
ETH
OD
S
MET
HO
DS
M
ETH
OD
S
DIS
CLO
SUR
ES
RES
ULT
S Baseline Demographics and Disease Characteristics bull Baseline demographics and disease characteristics were generally balanced
across treatment groups (Table 2)
Table 2 Baseline demographics and disease characteristics
Study Designbull Phase 3 randomized double-blind placebo-controlled study
(Clinicaltrialsgov identifi er NCT01603628) (Table 1 Figure 1)
Assessmentsbull Primary outcome measure
Change from baseline in Modifi ed Ashworth Scale (MAS)4
ankle score at weeks 4 and 6 (average change from baseline)bull Secondary outcome measures
Clinical Global Impression of Change (CGI)5
Change in Modifi ed Tardieu Scale6
Goal Attainment Score7
bull Other measures Edinburgh Visual Gait Score
bull Safety and tolerability of treatments were also assessed
Table 1 General overview of lower limb pediatric study
12 Weeks9631 2 4 5 7 8 10 11
Primary endpointAverage of
weeks 4 and 6
Randomization and treatment
Screening MAS ge2 of ankleOnabotulinumtoxinA 8 Ukg + PT
OnabotulinumtoxinA 4 Ukg + PT
Placebo + PT
MAS = Modifi ed Ashworth Scale PT = physical therapy
Figure 1 Study design
OnabotulinumtoxinA in conjunction with standardized physical therapy
was safe and effective in treating lower limb spasticity in pediatric patients
with cerebral palsy
Statistically signifi cant improvement in the primary and secondary outcomes was observed with
onabotulinumtoxinA over standardized physical therapy alone
The safety profi le of onabotulinumtoxinA was
similar to that with placebo and no new safety signals
were identifi ed
Patientsindication Spasticity in ankle
Medically stable monoplegic or hemiplegic children
Aged 2ndashlt17 years with spasticity due to cerebral palsy
Duration Double-blind 12-week trial
InterventionsOnabotulinumtoxinA 4 UkgOnabotulinumtoxinA 8 Ukg + Standardized physical therapyPlacebo
Muscle injection required
GastrocnemiusSoleusTibialis posterior
GastrocnemiusCalfmuscles
Soleus
Achilles tendon
OnabotA 8 Ukg(n=127)
OnabotA 4 Ukg(n=125)
Placebo (n=129)
Total (N=381)
Mean (SD) age y 67 (39) 64 (36) 67 (39) 66 (38)le6 n () 74 (583) 73 (584) 74 (574) 221 (580)gt6 n () 53 (417) 52 (416) 55 (426) 160 (420)
Male n () 70 (551) 67 (536) 69 (535) 206 (541)Race n ()
White 76 (598) 76 (608) 79 (612) 231 (606)Asian 42 (331) 35 (280) 37 (287) 114 (299)Other 9 (71) 14 (112) 13 (101) 36 (94)
Hemiplegia n ()a 110 (866) 109 (872) 110 (853) 329 (864)Mean (SD) MAS ankle derived score knee extendedb
35 (052) 35 (053) 35 (050)
GMFCS ndash E and R n ()Level 1 69 (539) 65 (516) 65 (508) 199 (518)Level 2 54 (422) 51 (405) 56 (438) 163 (422)Levels 3 and 4 5 (39) 10 (80) 7 (55) 22 (57)
aAll others had monoplegia bMAS scale was converted from a 0ndash4 to 1ndash5 scaleGMFCS ndash E and R = Gross Motor Function Classifi cation System ndash Expanded and Revised MAS = Modifi ed Ashworth Scale OnabotA = OnabotulinumtoxinA SD = standard deviation
Effi cacy Outcomesbull OnabotulinumtoxinA 8 Ukg and 4 Ukg reduced (improved) average MAS-ankle
scores at weeks 4 and 6 compared with baseline Compared with the placebo group the change in MAS-ankle scores from
baseline were signifi cantly improved for both onabotulinumtoxinA treatment groups (Figure 2)
bull OnabotulinumtoxinA 8 Ukg and 4 Ukg increased (improved) average CGI scores at weeks 4 and 6
The increase with the 8-Ukg dose was statistically signifi cant (Figure 3)
Figure 2 OnabotulinumtoxinA reduces spasticity over the standard of care physical therapy
Figure 3 OnabotulinumtoxinA improves CGI over the standard of care physical therapy
Statistically signifi cant vs placeboMAS = Modifi ed Ashworth Scale OnabotA = onabotulinumtoxinA
Statistically signifi cant vs placeboCGI = Clinical Global Impression of Change OnabotA = onabotulinumtoxinA
Impr
ovem
ent
-10
-08
-06
-04
-02
-14
-12
0
MA
S k
nee
exte
nded
m
ean
chan
ge fr
om b
asel
ine
OnabotA8 Ukg
OnabotA4 Ukg Placebo
P=010
P=033
Impr
ovem
ent
04
06
08
12
10
14
16
0
02
18
Mea
n C
GI
OnabotA8 Ukg
OnabotA4 Ukg
Placebo
P=023 P=229
bull Both doses of onabotulinumtoxinA demonstrated signifi cant reduction in muscle tone (MAS scores) from baseline throughout the course of the study compared with placebo (Figure 4A)
bull A greater treatment response (CGI as determined by the physician) was observed at weeks 2 4 and 6 with onabotulinumtoxinA compared with placebo (Figure 4B)
Figure 4 OnabotulinumtoxinA demonstrates sustained improvement in (A) MAS and (B) CGI
-08
-04
-02
-06
-12
-14
-10
0
MA
S ch
ange
from
bas
elin
e
0 2 8 10 12WeekA
64
OnabotA 8 UkgOnabotA 4 UkgPlacebo
Impr
ovem
ent
OnabotA 8 UkgOnabotA 4 UkgPlacebo
08
16
18
14
12
10
04
02
0
06
20
Mea
n C
GI s
core
0 2 108 12Week 64
Impr
ovem
ent
B
Safety and Tolerabilitybull The incidence of adverse events with onabotulinumtoxinA was
similar to that with placebo (Table 3)bull No new safety signals were identifi ed
Table 3 Safety and tolerability
AEs n ()OnabotA 8 Ukg
(n=128)OnabotA 4 Ukg
(n=126)All OnabotA
(n=254)Placebo (n=128)
Treatment-emergent AEs 56 (438) 54 (429) 110 (433) 63 (492)
SAEs 0 3 (24)a 3 (12) 4 (31)b
Treatment-related AEs 4 (31) 3 (24) 7 (28) 2 (16)
Treatment-related SAEs 0 0 0 0
Discontinued owing to AE 0 0 0 0
Deaths 0 0 0 0aSAEs included cardiac disorders (extrasystole and tachycardia) seizure and tonsillar hypertrophy bSAEs included gastroenteritis seizure (n=2) and radicular painAE = adverse event OnabotA = OnabotulinumtoxinA SAE = serious adverse event
bull With the knee extended both doses of onabotulinumtoxinA signifi cantly improved the dynamic component of spasticity (Figure 6)
Both doses of onabotulinumtoxinA improved fast motion angle (R1) and slow motion angle (R2) measures
bull Similar results were observed when the knee was fl exedbull In a subset of patients who completed the assessment
onabotulinumtoxinA 8 Ukg demonstrated statistically signifi cant improvement in Edinburgh Visual Gait Total Score at week 8 (Figure 7)
bull The photographs in Figure 8 show representative examples of the improvement in gait seen with onabotulintoxinA
Figure 6 OnabotulinumtoxinA reduces dynamic tone (MTS)
Figure 5 OnabotulinumtoxinA improves active and passivefunctional goal attainment
Statistically signifi cant vs placeboMTS = Modifi ed Tardieu Scale OnabotA = onabotulinumtoxinA R2-R1 = difference between slow motion angle (R2) and fast motion angle (R1)
Statistically signifi cant vs placeboOnabotA = onabotulinumtoxinA
-02
0
04
02
-06
-04
06
8Active Passive
12 8 12 Week
Exce
eds
expe
ctat
ion
Meetsexpectation
Less
than
expe
ctat
ion
P=005P=047
P=001
P=004
P=01
OnabotA 8 UkgOnabotA 4 UkgPlacebo
Goa
l atta
inm
ent
-9
-8
-5
-6
-7
-3
-4
-2
-1
0
MTS
ank
le s
core
chan
ge fr
om b
asel
ine
in R
2-R
1
2 4 6 8 12Week
Impr
ovem
ent
P=02
P=02
P=006
OnabotA 8 UkgOnabotA 4 UkgPlacebo
Figure 7 OnabotulinumtoxinA improves gait more than physical therapy alone
Figure 8 Photos representative of the improvements seen ingait following treatment with OnabotulinumtoxinA
Statistically signifi cant vs placeboOnabotA = onabotulinumtoxinA
MAS = Modifi ed Ashworth Scale OnabotA = onabotulinumtoxinA
-40
-25
-30
-35
-15
-20
-10
-05
0
Edin
burg
h vi
sual
gai
t tot
al s
core
chan
ge fr
om b
asel
ine
8 12Week
Impr
ovem
ent
P=018
OnabotA 8 Ukg (n=26)OnabotA 4 Ukg (n=20)Placebo (n=17)
A 2-year-old male MASbaseline=3 MASweek 8=1OnabotA 8 Ukg
Week 8BaselinePlease scan QR code below to view videos of these children
B 2-year-old female MASbaseline=3 MASweek 8=2OnabotA 4 Ukg
Week 8BaselinePlease scan QR code below to view videos of these children
bull OnabotulinumtoxinA 8 Ukg and 4 Ukg both demonstrated greater active (eg walking speed endurance balance improved gait) and passive (eg pain tolerance of orthotic devices reduction in care needs) goal achievements than placebo (Figure 5)
Statistically signifi cant vs placeboCGI = Clinical Global Impression of Change MAS = Modifi ed Ashworth Scale OnabotA = onabotulinumtoxinA
SUM
MA
RY
P337