BOTOX® Treatment in Pediatric Upper Limb Spasticity: Open-label Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pediatrics
- Sponsor
- Allergan
- Enrollment
- 220
- Locations
- 48
- Primary Endpoint
- Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric upper limb spasticity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Minimum weight of 10 Kilograms (kg) / 22 Pounds (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 3 months
- •History of surgical intervention of the upper limb within 1 year, or planned surgery of any limb during the study
Outcomes
Primary Outcomes
Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE)
Time Frame: From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period. Safety population included all treated participants.