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

• Status: Completed
• Trial end date: 2015-05-01
• 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 leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.

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

Details

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

Criteria

Inclusion Criteria:

• Age from 18-80 yrs

• Lower 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 lower limb

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

• Infection at the injection site