Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.

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

Details

• Lead Sponsor: Merz Pharmaceuticals GmbH
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Upper limb spasticity

• Time since stroke greater than 3 months

• Need for 400 U Botulinum toxin type A

Exclusion Criteria:

• Body weight below 50kg

• Fixed contractures of the upper limb

• Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin Type A

• Infection at the injection site