Status:
COMPLETED
Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Allergan
Conditions:
Stroke
Brain Injuries
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief 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.
Detailed Description
Spasticity is one of the most debilitating complications of neurologic conditions, such as stroke, brain injury, spinal cord injury, cerebral palsy, and multiple sclerosis. Although the exact pathophy...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00178646
Start Date
January 1 2002
End Date
March 1 2010
Last Update
January 22 2021
Active Locations (2)
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1
Kessler Institute for Rehabiliation
West Orange, New Jersey, United States, 07052
2
Memorial Hermann Hospital
Houston, Texas, United States, 77030