Trial · NCT01603628

BOTOX® Treatment in Pediatric Lower Limb Spasticity

NCT01603628, 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 Lower Limb Spasticity. Trials, record NCT01603628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01603628

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Trial

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

Title: BOTOX® Treatment in Pediatric Lower Limb Spasticity
NCT number: NCT01603628
Status: Completed
Phases: Phase 3
Enrollment: 384 participants, actual
Lead sponsor: Allergan
Conditions: Pediatrics, Muscle Spasticity, Cerebral Palsy
Interventions: botulinum toxin Type A, Normal Saline (Placebo)
First posted: 2012-05-22
Last updated: 2018-08-14
Other registries' IDs: eudract:2012-000042-35
Results first posted: 2018-08-14

Source ClinicalTrials.gov

Registered outcomes4

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) Ankle Score With Knee Extended 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 Mixed Model Repeated Measures (MMRM) model was used for analysis.
Secondary	Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale	Weeks 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 Analysis of Covariance (ANCOVA) model was used for analysis.
Secondary	Change From Baseline in Severity of Spasticity of the Ankle With Knee Extended and Knee Flexed (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)	Baseline (Day 1) to Weeks 2, 4, 6, 8 and 12	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 fast velocity passive stretch determining the dynamic component of the muscle contracture for the joint. 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 R2 and R1 range of motion and respective change from baseline to each posttreatment office visit on the MTS was derived. An Analysis of Covariance (ANCOVA) model was used for analysis.

Source ClinicalTrials.gov

Outcomes4

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) Ankle Score With Knee Extended 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 ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended 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 mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale	Weeks 8 and 12	Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended 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 Ankle With Knee Extended and Knee Flexed (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)	Baseline (Day 1) to Weeks 2, 4, 6, 8 and 12	Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis at the given time-point.	degrees	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group33

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) Ankle Score With Knee Extended at Weeks 4 and 6	BOTOX® 8 U/kg		-1.06	Standard Error 0.071	score on a scale
Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score With Knee Extended at Weeks 4 and 6	BOTOX® 4 U/kg		-1.01	Standard Error 0.072	score on a scale
Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score With Knee Extended at Weeks 4 and 6	Placebo		-0.80	Standard Error 0.071	score on a scale
Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6	BOTOX® 8 U/kg		1.65	Standard Error 0.090	score on a scale
Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6	BOTOX® 4 U/kg		1.49	Standard Error 0.091	score on a scale
Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6	Placebo		1.36	Standard Error 0.089	score on a scale
Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale	BOTOX® 8 U/kg	Week 8, Active Goal	0.10	Standard Error 0.108	score on a scale
Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale	BOTOX® 4 U/kg	Week 8, Active Goal	-0.03	Standard Error 0.108	score on a scale
Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale	Placebo	Week 8, Active Goal	-0.31	Standard Error 0.105	score on a scale
Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale	BOTOX® 8 U/kg	Week 8, Passive Goal	0.19	Standard Error 0.115	score on a scale

1 to 10 of 33Source ClinicalTrials.gov

See all 33 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	BOTOX® 8 U/kg	128
Overall Study	STARTED	BOTOX® 4 U/kg	126
Overall Study	STARTED	Placebo	130
Overall Study	Safety Population: Received Treatment	BOTOX® 8 U/kg	128
Overall Study	Safety Population: Received Treatment	BOTOX® 4 U/kg	126
Overall Study	Safety Population: Received Treatment	Placebo	128
Overall Study	COMPLETED	BOTOX® 8 U/kg	125
Overall Study	COMPLETED	BOTOX® 4 U/kg	123
Overall Study	COMPLETED	Placebo	128
Overall Study	NOT COMPLETED	BOTOX® 8 U/kg	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events27

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	Pyrexia	General disorders	BOTOX® 8 U/kg	5	128
other	Pyrexia	General disorders	BOTOX® 4 U/kg	8	126
other	Pyrexia	General disorders	Placebo	7	128
other	Viral upper respiratory tract infection	Infections and infestations	BOTOX® 8 U/kg	12	128
other	Viral upper respiratory tract infection	Infections and infestations	BOTOX® 4 U/kg	14	126
other	Viral upper respiratory tract infection	Infections and infestations	Placebo	22	128
other	Upper respiratory tract infection	Infections and infestations	BOTOX® 8 U/kg	8	128
other	Upper respiratory tract infection	Infections and infestations	BOTOX® 4 U/kg	10	126
other	Upper respiratory tract infection	Infections and infestations	Placebo	9	128
serious	Extrasystoles	Cardiac disorders	BOTOX® 8 U/kg	0	128

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BOTOX® 8 U/kg	0	128
Total, all-cause mortality	BOTOX® 4 U/kg	0	126
Total, all-cause mortality	Placebo	0	128
Total, other adverse events	BOTOX® 8 U/kg	24	128
Total, other adverse events	BOTOX® 4 U/kg	26	126
Total, other adverse events	Placebo	35	128
Total, serious adverse events	BOTOX® 8 U/kg	0	128
Total, serious adverse events	BOTOX® 4 U/kg	3	126
Total, serious adverse events	Placebo	4	128

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/NCT01603628

GET https://conductscience.org/api/trials/v1/NCT01603628/results?page=2

API reference For AI assistants