Phase 3
N=384
BOTOX® Treatment in Pediatric Lower Limb Spasticity
Pediatrics · Muscle Spasticity · Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT01603628 ↗Enrolled (actual)
384
Serious AEs
1.8%
Results posted
Aug 2018
Primary outcome: Primary: Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score With Knee Extended at Weeks 4 and 6 — -1.06; -1.01; -0.80 score on a scale — p=0.010
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- botulinum toxin Type A (Biological); Normal Saline (Placebo) (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score With Knee Extended at Weeks 4 and 6 |
-1.06; -1.01; -0.80 | 0.010 sig |
| PRIMARY Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6 |
1.65; 1.49; 1.36 | 0.023 sig |
| SECONDARY Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale |
0.10; -0.03; -0.31; 0.19; 0.18; -0.26 | 0.005 sig |
| 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) |
-4.44; -5.69; -2.44; -6.11; -6.80; -4.69 | 0.158 |
Summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.
Eligibility Criteria
Inclusion Criteria
- Minimum weight of 10 kg/22 lb
- Cerebral palsy with dynamic muscle contracture /spasticity of the ankle
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
- History of surgical intervention of the lower study leg or planned surgery of any 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 upper limb during the study
Data sourced from ClinicalTrials.gov (NCT01603628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.