Phase 3
N=370
BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
Pediatrics · Muscle Spasticity · Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT01603641 ↗Enrolled (actual)
370
Serious AEs
6.5%
Results posted
Aug 2019
Primary outcome: Primary: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) — 65.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum Toxin Type A (Biological)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) |
65.4 | — |
Summary
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.
Eligibility Criteria
Inclusion Criteria
- Minimum weight of 10 kilograms (kg)/22 pounds (lb)
- Cerebral palsy with dynamic muscle contracture 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 3 months
- History of surgical intervention of the lower study leg within 1 year, or planned surgery of any limb during the study
Data sourced from ClinicalTrials.gov (NCT01603641). 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.