BOTOX® Treatment in Pediatric Lower Limb Spasticity

• Status: Completed
• Trial end date: 2017-06-28
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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