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CompletedNCT01603602Updated Aug 14, 2018Results posted

BOTOX® Treatment in Pediatric Upper Limb Spasticity

A Phase 3 interventional study of botulinum toxin Type A and Normal Saline (Placebo) in Pediatrics, Muscle Spasticity and Cerebral Palsy, sponsored by Allergan. Completed at 45 sites in 9 countries. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2018-08-14.

Sponsored by Allergan · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
235
Allocation
Randomized
Ages
2 Years to 16 Years
Sex
All
01

Study summary

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper limb spasticity.

02

Conditions studied

  • Pediatrics
  • Muscle Spasticity
  • Cerebral Palsy
  • Stroke
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 235 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Minimum weight of 10 kg/22 lb
  • Upper limb spasticity due to cerebral palsy or stroke

Exclusion criteria

Exclusion Criteria:

  • Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease
  • Uncontrolled epilepsy
  • Botulinum Toxin therapy of any serotype for any condition within the last 6 months
  • Previous surgical treatment of the study limb (except tendon lengthening), or planned surgery of the study limb during the study
  • Previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected lower limb during the study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
235 participants (actual)

Study arms

  • Experimental
    BOTOX® 3 U/kg

    Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 units (U) per kilogram (kg) of body weight (3 U/kg) into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).

    Biological: botulinum toxin Type A

  • Experimental
    BOTOX® 6 U/kg

    Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U per kg of body weight (6 U/kg) into specified muscles of the upper limb on Day 1. Participants received weekly OT.

    Biological: botulinum toxin Type A

  • Placebo comparator
    Placebo

    Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.

    Drug: Normal Saline (Placebo)

Interventions

  • Biologicalbotulinum toxin Type A

    Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.

    Also known as: BOTOX®, onabotulinumtoxinA

  • DrugNormal Saline (Placebo)

    Intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1.

06

What researchers measure

Primary outcomes

  1. Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6

    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.

    Time frame: Baseline (Day 1) to Weeks 4 and 6

  2. Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6

    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.

    Time frame: Weeks 4 and 6

Secondary outcomes

  1. Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6

    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.

    Time frame: Baseline (Day 1) to Weeks 4 and 6

  2. Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale

    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.

    Time frame: Week 8 and 12

  3. Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)

    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.

    Time frame: Baseline (Day 1) to Week 6

07

Results

Posted Aug 14, 2018

Participant flow

Participant flow — Overall Study
MilestoneBOTOX® 6 U/kgBOTOX® 3 U/kgPlacebo
Started777880
Completed757879
Not completed201
Withdrew: Adverse event100
Withdrew: Personal reasons101

Outcome measures

PrimaryAverage Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6

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.

Time frame:
Baseline (Day 1) to Weeks 4 and 6
Reported as:
Least squares mean · score on a scale
Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6
score on a scaleBOTOX® 6 U/kgBOTOX® 3 U/kgPlacebo
Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6-1.87 ± 0.102-1.92 ± 0.101-1.21 ± 0.102
Statistical analysis
  • BOTOX® 6 U/kg vs Placebo · Mixed Model Repeated Measures (MMRM) · p = <0.001 (MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.) · Least squares (ls) mean difference: -0.66 · 95% CI -0.938 to -0.379
  • BOTOX® 3 U/kg vs Placebo · MMRM · p = <0.001 (MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.) · Ls mean difference: -0.71 · 95% CI -0.992 to -0.426
PrimaryAverage Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6

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.

Time frame:
Weeks 4 and 6
Reported as:
Least squares mean · score on a scale
Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6
score on a scaleBOTOX® 6 U/kgBOTOX® 3 U/kgPlacebo
Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 61.87 ± 0.1081.88 ± 0.1081.66 ± 0.108
Statistical analysis
  • BOTOX® 6 U/kg vs Placebo · MMRM · p = 0.155 (MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.) · Ls mean difference: 0.21 · 95% CI -0.082 to 0.511
  • BOTOX® 3 U/kg vs Placebo · MMRM · p = 0.147 (MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.) · Ls mean difference: 0.22 · 95% CI -0.079 to 0.523
SecondaryAverage Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6

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.

Time frame:
Baseline (Day 1) to Weeks 4 and 6
Reported as:
Least squares mean · score on a scale
Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6
score on a scaleBOTOX® 6 U/kgBOTOX® 3 U/kgPlacebo
Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6-1.41 ± 0.184-1.46 ± 0.169-1.02 ± 0.170
Statistical analysis
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.111 (ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: -0.39 · 95% CI -0.861 to 0.091
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.078 (ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: -0.44 · 95% CI -0.933 to 0.051
SecondaryGoal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale

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.

Time frame:
Week 8 and 12
Reported as:
Least squares mean · score on a scale
Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale
score on a scaleBOTOX® 6 U/kgBOTOX® 3 U/kgPlacebo
Week 8, Active Goal0.11 ± 0.1480.12 ± 0.1480.21 ± 0.148
Week 8, Passive Goal0.30 ± 0.1460.23 ± 0.1460.06 ± 0.146
Week 12, Active Goal0.49 ± 0.1430.26 ± 0.1390.52 ± 0.139
Week 12, Passive Goal0.71 ± 0.1430.31 ± 0.1390.11 ± 0.139
Statistical analysis
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.636 (ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.) · Ls mean difference: -0.10 · 95% CI -0.498 to 0.305
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.658 (ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.) · Ls mean difference: -0.09 · 95% CI -0.502 to 0.318
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.243 (ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.) · Ls mean difference: 0.24 · 95% CI -0.162 to 0.635
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.412 (ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.) · Ls mean difference: 0.17 · 95% CI -0.237 to 0.576
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.904 (ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.) · Ls mean difference: -0.02 · 95% CI -0.408 to 0.361
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.200 (ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.) · Ls mean difference: -0.25 · 95% CI -0.641 to 0.135
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.003 (ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.) · Ls mean difference: 0.59 · 95% CI 0.210 to 0.978
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.327 (ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.) · Ls mean difference: 0.19 · 95% CI -0.194 to 0.580
SecondaryChange From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)

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.

Time frame:
Baseline (Day 1) to Week 6
Reported as:
Least squares mean · degrees
Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)
degreesBOTOX® 6 U/kgBOTOX® 3 U/kgPlacebo
Change from Baseline to Week 2, Elbow33.27 ± 5.24629.58 ± 5.26821.17 ± 5.602
Change from Baseline to Week 4, Elbow31.49 ± 4.11628.63 ± 4.16016.78 ± 4.272
Change from Baseline to Week 6, Elbow37.62 ± 4.37228.00 ± 4.26816.65 ± 4.408
Change from Baseline to Week 8, Elbow31.17 ± 4.23823.14 ± 4.18815.92 ± 4.276
Change from Baseline to Week 12, Elbow14.69 ± 3.82814.06 ± 3.77510.19 ± 3.854
Change from Baseline to Week 2, Wrist-15.72 ± 4.096-24.20 ± 3.831-9.60 ± 3.877
Change from Baseline to Week 4, Wrist-22.97 ± 4.965-25.43 ± 4.557-12.33 ± 4.447
Change from Baseline to Week 6, Wrist-24.33 ± 5.036-18.47 ± 4.641-7.22 ± 4.570
Change from Baseline to Week 8, Wrist-20.87 ± 4.621-18.90 ± 4.307-3.16 ± 4.303
Change from Baseline to Week 12, Wrist-16.87 ± 4.927-15.14 ± 4.607-1.62 ± 4.509
Statistical analysis
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.117 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: 12.10 · 95% CI -3.089 to 27.293
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.273 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: 8.41 · 95% CI -6.717 to 23.527
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.015 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: 14.71 · 95% CI 2.958 to 26.458
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.046 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: 11.85 · 95% CI 0.203 to 23.504
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = <0.001 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: 20.97 · 95% CI 8.801 to 33.137
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.064 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: 11.35 · 95% CI -0.662 to 23.362
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.013 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: 15.25 · 95% CI 3.317 to 27.178
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.225 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: 7.22 · 95% CI -4.488 to 18.934
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.409 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: 4.50 · 95% CI -6.239 to 15.236
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.470 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: 3.86 · 95% CI -6.690 to 14.419
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.263 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: -6.13 · 95% CI -16.962 to 4.706
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.012 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: -14.60 · 95% CI -25.846 to -3.360
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.098 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: -10.64 · 95% CI -23.277 to 1.996
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.051 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: -13.10 · 95% CI -26.260 to 0.068
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.010 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: -17.11 · 95% CI -30.031 to -4.189
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.098 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: -11.25 · 95% CI -24.622 to 2.131
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.005 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: -17.71 · 95% CI -29.888 to -5.537
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.015 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: -15.74 · 95% CI -28.293 to -3.194
  • BOTOX® 6 U/kg vs Placebo · ANCOVA · p = 0.020 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: -15.25 · 95% CI -28.010 to -2.492
  • BOTOX® 3 U/kg vs Placebo · ANCOVA · p = 0.046 (ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.) · Ls mean difference: -13.52 · 95% CI -26.797 to -0.243

Adverse events

Collected over Baseline (Day 1) to end of the study (Week 12). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BOTOX® 6 U/kg0/77 (0%)3/77 (3.9%)15/77 (19.5%)
BOTOX® 3 U/kg0/78 (0%)1/78 (1.3%)12/78 (15.4%)
Placebo0/79 (0%)1/79 (1.3%)17/79 (21.5%)
Most frequent serious events
Most frequent serious events
EventBOTOX® 6 U/kgBOTOX® 3 U/kgPlacebo
StomatitisGastrointestinal disorders1/770/780/79
VomitingGastrointestinal disorders1/770/780/79
PyrexiaGeneral disorders1/770/780/79
Infectious mononucleosisInfections and infestations1/770/780/79
SeizureNervous system disorders1/770/780/79
MeningitisInfections and infestations0/771/780/79
OsteochondrosisMusculoskeletal and connective tissue disorders0/770/781/79
Most frequent other events
Most frequent other events
EventBOTOX® 6 U/kgBOTOX® 3 U/kgPlacebo
Upper respiratory tract infectionInfections and infestations7/774/782/79
Viral upper respiratory tract infectionInfections and infestations6/774/785/79
PyrexiaGeneral disorders2/773/785/79
Pain in extremityMusculoskeletal and connective tissue disorders2/771/784/79
HeadacheNervous system disorders1/772/784/79

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(years)BOTOX® 6 U/kgBOTOX® 3 U/kgPlaceboTotal
Mean7.6 ± 3.668.3 ± 4.487.8 ± 4.067.9 ± 4.07
Sex: Female, Male
Sex: Female, Male(Participants)BOTOX® 6 U/kgBOTOX® 3 U/kgPlaceboTotal
Female27363295
Male504248140
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)BOTOX® 6 U/kgBOTOX® 3 U/kgPlaceboTotal
White514251144
Black3339
Asian19271864
Hispanic24511
Other Unspecified2215
Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group Change
Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group Change(score on a scale)BOTOX® 6 U/kgBOTOX® 3 U/kgPlaceboTotal
Mean3.3 ± 0.453.3 ± 0.453.3 ± 0.443.3 ± 0.45
08

Study locations

45 sites
  • AMS Neurology
    Pasadena, California 91106, United States
  • Harrison Clinical Management
    Pomona, California 91766, United States
  • Children's Hospital Colorado Dept. of PM&R
    Aurora, Colorado 80045, United States
  • Associated Neurologists of Southern CT, P.C.
    Fairfield, Connecticut 06824, United States
  • NW FL Clinical Research Group, LLC
    Gulf Breeze, Florida 32561, United States
  • Axcess Medical Research, LLC
    Loxahatchee Groves, Florida 33470, United States
  • Pediatric Neurology, PA
    Orlando, Florida 32891, United States
  • Children's Healthcare of Atlanta Children's Rehabilitation Associates
    Atlanta, Georgia 30342, United States
  • Gillette Children's Specialty Healthcare
    Saint Paul, Minnesota 55101, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Clinical Research Center of New Jersey
    Voorhees, New Jersey 08043, United States
  • NYU Hospital for Joint Diseases
    New York, New York 10003, United States
  • Columbia University Medical Center Dept. of Rehab. & Regenerative Medicine
    New York, New York 10032, United States
  • OnSite Clinical Solutions, LLC
    Charlotte, North Carolina 28203, United States
  • PMG Research if Charlotte, LLC
    Charlotte, North Carolina 28203, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Baylor College of Medicine Texas Children's Hospital
    Houston, Texas 77030, United States
  • Road Runner Research
    San Antonio, Texas 78258, United States
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
  • Marshfield Clinic
    Marshfield, Wisconsin 54449, United States
  • Holland Bloorview Kids Rehab
    Toronto, Ontario M4G 1R8, Canada
  • Debrecen University Clinical Center, Orthopedic Clinic
    Debrecen, 4032, Hungary
  • Daegu Fatima Hospital
    Daegu, 41199, Korea, Republic of
  • National Health Insurance Service Ilsan Hospital
    Goyang-si, 10444, Korea, Republic of
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
  • Severance Hospital, Yonsei University Health System
    Seoul, 03722, Korea, Republic of
  • Asan Medical Center
    Seoul, 05505, Korea, Republic of
  • Samsung Medical Center
    Seoul, 06351, Korea, Republic of
  • De La Salle University Medical Center
    Dasmarinas, Cavite 4114, Philippines
  • Philippine Children's Medical Center
    Bagong Pag-asa, Quezon City 1104, Philippines
  • Uni Centrum Kliniczne
    Gdansk, 80-219, Poland
  • Specjal. Gabinet Neurologiczny
    Krakow, 30-359, Poland
  • Centrum Medyczne "POMOC"
    Lodz, 93-271, Poland
  • INTERMED, Lublin
    Lublin, 20-058, Poland
  • CRH ŻAGIEL MED, Lublin
    Lublin, 20-601, Poland
  • Neuro - Dzieci I Mlodziezy Aga
    Warsaw, 02-315, Poland
  • NZOZ Mazowieckie Centrum
    Warsaw, 05-462, Poland
  • Childrens Republic Hospital
    Kazan, 420138, Russian Federation
  • Smolensk Regional Hospital- Regional Budget State Healthcare institution
    Smolensk, 214018, Russian Federation
  • Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region
    Tyumen, 625039, Russian Federation
  • Siriraj Hospital, Mahidol University
    Bangkok, 10700, Thailand
  • Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
    Chiang Mai, 50200, Thailand
  • Srinagarind Hospital, Khon Kaen University
    Khon Kaen, 40002, Thailand
  • Ankara Diskapi Yildrim Beyazit
    Ankara, 6110, Turkey
  • Kocaeli Üniversitesi
    Kocaeli, 41380, Turkey
09

References and documents

Study documents

  • Study protocol · Jul 22, 2016
  • Statistical analysis plan · Sep 11, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01603602
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
May 22, 2012
Start date
Jul 12, 2012
Primary completion
Jun 29, 2017
Completion
Jul 6, 2017
Results posted
Aug 14, 2018
Last update
Aug 14, 2018

Study contacts

Rozalina Dimitrova
study director · Allergan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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