Trial Outcomes & Findings for BOTOX® Treatment in Pediatric Upper Limb Spasticity (NCT NCT01603602)
NCT ID: NCT01603602
Last Updated: 2018-08-14
Results Overview
The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the principal muscle group (elbow and wrist) by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis. A negative change from Baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
235 participants
Primary outcome timeframe
Baseline (Day 1) to Weeks 4 and 6
Results posted on
2018-08-14
Participant Flow
Pediatric participants with upper limb spasticity were randomized 1:1:1 to one of three treatment groups: BOTOX® 3 or 6 U/kg (unit per kilogram) or placebo.
Participant milestones
| Measure |
BOTOX® 6 U/kg
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
|
BOTOX® 3 U/kg
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
Placebo
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
|---|---|---|---|
|
Overall Study
STARTED
|
77
|
78
|
80
|
|
Overall Study
COMPLETED
|
75
|
78
|
79
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
BOTOX® 6 U/kg
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
|
BOTOX® 3 U/kg
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
Placebo
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Personal Reasons
|
1
|
0
|
1
|
Baseline Characteristics
mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
Baseline characteristics by cohort
| Measure |
BOTOX® 6 U/kg
n=77 Participants
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
|
BOTOX® 3 U/kg
n=78 Participants
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
Placebo
n=80 Participants
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
7.6 years
STANDARD_DEVIATION 3.66 • n=77 Participants
|
8.3 years
STANDARD_DEVIATION 4.48 • n=78 Participants
|
7.8 years
STANDARD_DEVIATION 4.06 • n=80 Participants
|
7.9 years
STANDARD_DEVIATION 4.07 • n=235 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=77 Participants
|
36 Participants
n=78 Participants
|
32 Participants
n=80 Participants
|
95 Participants
n=235 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=77 Participants
|
42 Participants
n=78 Participants
|
48 Participants
n=80 Participants
|
140 Participants
n=235 Participants
|
|
Race/Ethnicity, Customized
White
|
51 Participants
n=77 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
42 Participants
n=78 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
51 Participants
n=79 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
144 Participants
n=234 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=77 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
3 Participants
n=78 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
3 Participants
n=79 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
9 Participants
n=234 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
|
Race/Ethnicity, Customized
Asian
|
19 Participants
n=77 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
27 Participants
n=78 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
18 Participants
n=79 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
64 Participants
n=234 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=77 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
4 Participants
n=78 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
5 Participants
n=79 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
11 Participants
n=234 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
|
Race/Ethnicity, Customized
Other Unspecified
|
2 Participants
n=77 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
2 Participants
n=78 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
1 Participants
n=79 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
5 Participants
n=234 Participants • mITT population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
|
Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group Change
|
3.3 score on a scale
STANDARD_DEVIATION 0.45 • n=77 Participants • Modifided Intent-to-treat (mITT) population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
3.3 score on a scale
STANDARD_DEVIATION 0.45 • n=78 Participants • Modifided Intent-to-treat (mITT) population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
3.3 score on a scale
STANDARD_DEVIATION 0.44 • n=79 Participants • Modifided Intent-to-treat (mITT) population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
3.3 score on a scale
STANDARD_DEVIATION 0.45 • n=234 Participants • Modifided Intent-to-treat (mITT) population included all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician.
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Weeks 4 and 6Population: Participants from the Modified Intent-to treat (mITT) population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis.
The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the principal muscle group (elbow and wrist) by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
BOTOX® 6 U/kg
n=74 Participants
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
|
BOTOX® 3 U/kg
n=76 Participants
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
Placebo
n=75 Participants
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
|---|---|---|---|
|
Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6
|
-1.87 score on a scale
Standard Error 0.102
|
-1.92 score on a scale
Standard Error 0.101
|
-1.21 score on a scale
Standard Error 0.102
|
PRIMARY outcome
Timeframe: Weeks 4 and 6Population: Participants from the m ITT population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis at the given time-point.
The CGI of overall change (improvement or worsening) was assessed by the physician considering the participant's clinical condition and severity of side effects using a 9-point scale where: -4=very marked worsening to +4=very marked improvement. The scores at Weeks 4 and 6 were averaged. A MMRM model was used for analysis.
Outcome measures
| Measure |
BOTOX® 6 U/kg
n=74 Participants
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
|
BOTOX® 3 U/kg
n=76 Participants
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
Placebo
n=75 Participants
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
|---|---|---|---|
|
Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6
|
1.87 score on a scale
Standard Error 0.108
|
1.88 score on a scale
Standard Error 0.108
|
1.66 score on a scale
Standard Error 0.108
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 4 and 6Population: Participants from the mITT population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis at the given time-point.
The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the finger flexor muscle group by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. An Analysis of Covariance (ANCOVA) model was used for analysis. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
BOTOX® 6 U/kg
n=28 Participants
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
|
BOTOX® 3 U/kg
n=30 Participants
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
Placebo
n=29 Participants
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
|---|---|---|---|
|
Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6
|
-1.41 score on a scale
Standard Error 0.184
|
-1.46 score on a scale
Standard Error 0.169
|
-1.02 score on a scale
Standard Error 0.170
|
SECONDARY outcome
Timeframe: Week 8 and 12Population: Participants from the mITT population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis at the given time-point.
Two functional goals, one active and one passive, were selected by the participant and family in consultation with the physician investigator and/or treating physical therapist relative to the lower limb impairment due to spasticity. The physician assessed the achievement of the goals using a 6-point scale: where -3=worse than start to +2=much more than expected: improvements clearly exceed the defined therapeutic goal. An ANCOVA model was used for analysis.
Outcome measures
| Measure |
BOTOX® 6 U/kg
n=77 Participants
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
|
BOTOX® 3 U/kg
n=78 Participants
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
Placebo
n=80 Participants
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
|---|---|---|---|
|
Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale
Week 12, Passive Goal
|
0.71 score on a scale
Standard Error 0.143
|
0.31 score on a scale
Standard Error 0.139
|
0.11 score on a scale
Standard Error 0.139
|
|
Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale
Week 8, Active Goal
|
0.11 score on a scale
Standard Error 0.148
|
0.12 score on a scale
Standard Error 0.148
|
0.21 score on a scale
Standard Error 0.148
|
|
Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale
Week 8, Passive Goal
|
0.30 score on a scale
Standard Error 0.146
|
0.23 score on a scale
Standard Error 0.146
|
0.06 score on a scale
Standard Error 0.146
|
|
Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale
Week 12, Active Goal
|
0.49 score on a scale
Standard Error 0.143
|
0.26 score on a scale
Standard Error 0.139
|
0.52 score on a scale
Standard Error 0.139
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 6Population: Participants from the mITT population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis at the given time-point.
The MTS measured the difference between slow and fast range of motion (R2-R1) and respective change from baseline to each posttreatment office visit. The MTS of the ankle was used to determine the passive range of movement at different movement velocities, V1 (as slow as possible) and V3 (as fast as possible) with the relative difference between a slow and a fast velocity passive stretch determining the dynamic component of the muscle contracture for the joint. At each visit, the investigator measured 2 joint angles by goniometer: the R1 angle which is the angle of catch after a fast velocity (V3) stretch and the R2 angle defined as the passive joint range of movement following a slow velocity (V1) stretch. The R2 - R1 value indicated the level of the dynamic component of spasticity in the joint. The difference between slow (R2) and fast (R1) range of motion and respective change from baseline to each posttreatment office visit on the MTS was derived.
Outcome measures
| Measure |
BOTOX® 6 U/kg
n=77 Participants
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
|
BOTOX® 3 U/kg
n=78 Participants
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
Placebo
n=80 Participants
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
|---|---|---|---|
|
Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)
Change from Baseline to Week 2, Elbow
|
33.27 degrees
Standard Error 5.246
|
29.58 degrees
Standard Error 5.268
|
21.17 degrees
Standard Error 5.602
|
|
Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)
Change from Baseline to Week 4, Elbow
|
31.49 degrees
Standard Error 4.116
|
28.63 degrees
Standard Error 4.160
|
16.78 degrees
Standard Error 4.272
|
|
Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)
Change from Baseline to Week 6, Elbow
|
37.62 degrees
Standard Error 4.372
|
28.00 degrees
Standard Error 4.268
|
16.65 degrees
Standard Error 4.408
|
|
Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)
Change from Baseline to Week 8, Elbow
|
31.17 degrees
Standard Error 4.238
|
23.14 degrees
Standard Error 4.188
|
15.92 degrees
Standard Error 4.276
|
|
Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)
Change from Baseline to Week 12, Elbow
|
14.69 degrees
Standard Error 3.828
|
14.06 degrees
Standard Error 3.775
|
10.19 degrees
Standard Error 3.854
|
|
Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)
Change from Baseline to Week 2, Wrist
|
-15.72 degrees
Standard Error 4.096
|
-24.20 degrees
Standard Error 3.831
|
-9.60 degrees
Standard Error 3.877
|
|
Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)
Change from Baseline to Week 4, Wrist
|
-22.97 degrees
Standard Error 4.965
|
-25.43 degrees
Standard Error 4.557
|
-12.33 degrees
Standard Error 4.447
|
|
Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)
Change from Baseline to Week 6, Wrist
|
-24.33 degrees
Standard Error 5.036
|
-18.47 degrees
Standard Error 4.641
|
-7.22 degrees
Standard Error 4.570
|
|
Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)
Change from Baseline to Week 8, Wrist
|
-20.87 degrees
Standard Error 4.621
|
-18.90 degrees
Standard Error 4.307
|
-3.16 degrees
Standard Error 4.303
|
|
Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)
Change from Baseline to Week 12, Wrist
|
-16.87 degrees
Standard Error 4.927
|
-15.14 degrees
Standard Error 4.607
|
-1.62 degrees
Standard Error 4.509
|
Adverse Events
BOTOX® 6 U/kg
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
BOTOX® 3 U/kg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BOTOX® 6 U/kg
n=77 participants at risk
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
|
BOTOX® 3 U/kg
n=78 participants at risk
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
Placebo
n=79 participants at risk
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
|---|---|---|---|
|
Gastrointestinal disorders
Stomatitis
|
1.3%
1/77 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/78 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/77 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/78 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
General disorders
Pyrexia
|
1.3%
1/77 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/78 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Infectious mononucleosis
|
1.3%
1/77 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/78 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Meningitis
|
0.00%
0/77 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.3%
1/78 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/77 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/78 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.3%
1/79 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Seizure
|
1.3%
1/77 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/78 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/79 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Other adverse events
| Measure |
BOTOX® 6 U/kg
n=77 participants at risk
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
|
BOTOX® 3 U/kg
n=78 participants at risk
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U/kg into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
Placebo
n=79 participants at risk
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
7/77 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.1%
4/78 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.5%
2/79 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.8%
6/77 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.1%
4/78 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
6.3%
5/79 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
General disorders
Pyrexia
|
2.6%
2/77 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.8%
3/78 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
6.3%
5/79 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
2/77 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.3%
1/78 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.1%
4/79 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Headache
|
1.3%
1/77 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.6%
2/78 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
5.1%
4/79 • Baseline (Day 1) to end of the study (Week 12)
The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER