BOTOX® Treatment in Pediatric Upper Limb Spasticity


Phase 3 Results N/A

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