Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.

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

Details

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

Criteria

Inclusion Criteria:

• Upper and lower limb spasticity of the same body side due to cerebral causes

• Time since event leading to spasticity in the target body side greater than 12 weeks

• Need for 800 units Botulinum toxin type A

Exclusion Criteria:

• Body weight below 50kg

• Fixed contractures of the target joint

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

• Infection at the injection site