Trial · NCT01603602

BOTOX® Treatment in Pediatric Upper Limb Spasticity

NCT01603602, Phase 3, Completed, Allergan; results first posted 2018-08-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BOTOX® Treatment in Pediatric Upper Limb Spasticity. Trials, record NCT01603602. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01603602

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: BOTOX® Treatment in Pediatric Upper Limb Spasticity
NCT number: NCT01603602
Status: Completed
Phases: Phase 3
Enrollment: 235 participants, actual
Lead sponsor: Allergan
Conditions: Pediatrics, Muscle Spasticity, Cerebral Palsy, Stroke
Interventions: botulinum toxin Type A, Normal Saline (Placebo)
First posted: 2012-05-22
Last updated: 2018-08-14
Other registries' IDs: eudract:2012-000062-38
Results first posted: 2018-08-14

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6	Baseline (Day 1) to 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.
Primary	Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6	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.
Secondary	Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6	Baseline (Day 1) to 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.
Secondary	Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale	Week 8 and 12	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.
Secondary	Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)	Baseline (Day 1) to Week 6	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6	Baseline (Day 1) to Weeks 4 and 6	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.	score on a scale	LEAST_SQUARES_MEAN
PRIMARY	Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6	Weeks 4 and 6	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.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6	Baseline (Day 1) to Weeks 4 and 6	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.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale	Week 8 and 12	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.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)	Baseline (Day 1) to Week 6	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.	degrees	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group51

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6	BOTOX® 6 U/kg		-1.87	Standard Error 0.102	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	BOTOX® 3 U/kg		-1.92	Standard Error 0.101	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	Placebo		-1.21	Standard Error 0.102	score on a scale
Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6	BOTOX® 6 U/kg		1.87	Standard Error 0.108	score on a scale
Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6	BOTOX® 3 U/kg		1.88	Standard Error 0.108	score on a scale
Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6	Placebo		1.66	Standard Error 0.108	score on a scale
Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6	BOTOX® 6 U/kg		-1.41	Standard Error 0.184	score on a scale
Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6	BOTOX® 3 U/kg		-1.46	Standard Error 0.169	score on a scale
Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6	Placebo		-1.02	Standard Error 0.170	score on a scale
Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale	BOTOX® 6 U/kg	Week 8, Active Goal	0.11	Standard Error 0.148	score on a scale

1 to 10 of 51Source ClinicalTrials.gov

See all 51 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	BOTOX® 6 U/kg	77
Overall Study	STARTED	BOTOX® 3 U/kg	78
Overall Study	STARTED	Placebo	80
Overall Study	COMPLETED	BOTOX® 6 U/kg	75
Overall Study	COMPLETED	BOTOX® 3 U/kg	78
Overall Study	COMPLETED	Placebo	79
Overall Study	NOT COMPLETED	BOTOX® 6 U/kg	2
Overall Study	NOT COMPLETED	BOTOX® 3 U/kg	0
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events36

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Upper respiratory tract infection	Infections and infestations	BOTOX® 6 U/kg	7	77
other	Upper respiratory tract infection	Infections and infestations	BOTOX® 3 U/kg	4	78
other	Upper respiratory tract infection	Infections and infestations	Placebo	2	79
other	Viral upper respiratory tract infection	Infections and infestations	BOTOX® 6 U/kg	6	77
other	Viral upper respiratory tract infection	Infections and infestations	BOTOX® 3 U/kg	4	78
other	Viral upper respiratory tract infection	Infections and infestations	Placebo	5	79
other	Pyrexia	General disorders	BOTOX® 6 U/kg	2	77
other	Pyrexia	General disorders	BOTOX® 3 U/kg	3	78
other	Pyrexia	General disorders	Placebo	5	79
other	Pain in extremity	Musculoskeletal and connective tissue disorders	BOTOX® 6 U/kg	2	77

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BOTOX® 6 U/kg	0	77
Total, all-cause mortality	BOTOX® 3 U/kg	0	78
Total, all-cause mortality	Placebo	0	79
Total, other adverse events	BOTOX® 6 U/kg	15	77
Total, other adverse events	BOTOX® 3 U/kg	12	78
Total, other adverse events	Placebo	17	79
Total, serious adverse events	BOTOX® 6 U/kg	3	77
Total, serious adverse events	BOTOX® 3 U/kg	1	78
Total, serious adverse events	Placebo	1	79

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01603602

GET https://conductscience.org/api/trials/v1/NCT01603602/results?page=2

API reference For AI assistants