Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 210
• Participant gender: Both

Summary

The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport used in the treatment of upper limb spasticity (altered skeletal muscle performance) in children with cerebral palsy (CP).

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

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA
• Last Updated: 2016-09-30

Criteria

Inclusion Criteria:

• Upper limb spasticity due to cerebral palsy

• Body weight 10 kg or over

• MAS score of 2 or more in affected elbow or wrist flexors

Exclusion Criteria:

• Fixed myocontracture

• Previous phenol or alcohol injection within 1 year

• Severe athetoid or dystonic movements

• Previous or planned surgery in elbow or wrist flexors

• Neuromuscular disorders

• Rhizotomy within 6 months

• Intrathecal baclofen within 30 days