Phase 3
N=235
BOTOX® Treatment in Pediatric Upper Limb Spasticity
Pediatrics · Muscle Spasticity · Cerebral Palsy · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01603602 ↗Enrolled (actual)
235
Serious AEs
2.1%
Results posted
Aug 2018
Primary outcome: Primary: Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6 — -1.87; -1.92; -1.21 score on a scale — p=<0.001
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) Score of the Principal Muscle Group at Weeks 4 and 6 |
-1.87; -1.92; -1.21 | <0.001 sig |
| PRIMARY Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6 |
1.87; 1.88; 1.66 | 0.155 |
| SECONDARY Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6 |
-1.41; -1.46; -1.02 | 0.111 |
| SECONDARY Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale |
0.11; 0.12; 0.21; 0.30; 0.23; 0.06 | 0.636 |
| SECONDARY Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS) |
33.27; 29.58; 21.17; 31.49; 28.63; 16.78 | 0.117 |
Summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper limb spasticity.
Eligibility Criteria
Inclusion Criteria
- Minimum weight of 10 kg/22 lb
- Upper limb spasticity due to cerebral palsy or stroke
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
Data sourced from ClinicalTrials.gov (NCT01603602). 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.