OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper 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:

• Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago

Exclusion Criteria:

• Spasticity in the non-study upper limb that requires treatment

• Presence of fixed contractures in of the study muscles in elbow or shoulder

• Profound atrophy of muscles to be injected

• Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months

• Injection of corticosteroids or anesthetics, use of casting or dynamic splinting or constraint-induced movement therapy (CIMT) for the study limb within 3 months

• Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month

• Condition other than stroke contributing to upper limb spasticity

• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis