Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating muscle tightness and spasms in the feet and ankles of people with stroke.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria -

• Spasticity resulting from ABI (stroke, including vascular malformations, traumatic brain injury)

• Ashworth Score (resting) of at least 2 of the primary ankle plantarflexor (gastrocnemius)

• Onset of primary illness at least six months prior to study inclusion

• At least 12 years of age

Exclusion Criteria -

• Hypersensitivity or allergy to botulinum toxin

• History of myasthenia gravis or other neuromuscular disease

• Current use of aminoglycosides

• Botulinum toxin or phenol injection to study limb within six months prior to recruitment

• Current use of other spasmolytic drug, such as diazepam, baclofen, dantrolene, tizanidine

• Presence of contracture or significant muscle atrophy

• Pregnancy