Botox vs. Baclofen for Upper Limb Spasticity
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|ClinicalTrials.gov Identifier: NCT00280280|
Recruitment Status : Terminated (low patient accrual)
First Posted : January 20, 2006
Last Update Posted : January 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Spasticity||Drug: intramuscular Botox versus oral baclofen||Phase 1|
Spasticity results from any injury to the central nervous system, including brain or spinal cord. Illnesses or injuries that typically cause spasticity include cerebral palsy, stroke, multiple sclerosis and traumatic brain or spinal cord injury. Common treatments for spasticity include physical and occupational therapy as well as oral medications such as baclofen, injected medications such as botulinum neurotoxin, intrathecal medications and surgical procedures. The approach to the treatment of spasticity is comprehensive in nature and these therapies have been widely applied to a broad population of patients including children, adults and older adults.
This is a single-center, randomized, prospective, parallel, double-blind study. Study duration is approximately 16 weeks.At Visit 2 (Baseline Visit), all eligible study subjects will be randomized to one of two treatment groups: intramuscular Botox plus oral placebo, or intramuscular placebo plus oral baclofen.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Double-blind Comparison of Botox Versus Baclofen for the Treatment of Subjects With Upper Limb Spasticity - Pilot Study|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
This study will explore the safety and effectiveness of Botox versus baclofen in treatment subjects with upper-limb spasticity due to neurological damage or a stable neurological disorder. Subjects will be randomized to one of two treatment groups: intramuscular Botox plus oral placebo or intramuscular placebo plus oral baclofen.
Drug: intramuscular Botox versus oral baclofen
Each vial of Botox contains 100 units of Clostridium botulinum toxin type A, 0.5 mg albumin (human) and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. Botox placebo is sterile normal saline (without preservatives) for injection. Baclofen is supplied as 10 mg tablets for oral administration. Inactive ingredients include colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone, wheat starch. Baclofen placebo tablets are composed of microcrystalline cellulose binder (99%), magnesium stearate 0.5%, and silica gel 0.5% and appear similar to commercial Baclofen tablets.
- Disability Assessment Scale (DAS) [ Time Frame: 4 months ]
- Modified Ashworth Tone [ Time Frame: 4 months ]
- Subject Questionnaires [ Time Frame: 4 months ]
- Contralateral Finger Tap Test [ Time Frame: 4 months ]
- Contralateral Grip Strength [ Time Frame: 4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280280
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232-2551|
|Principal Investigator:||P. David Charles, MD||Vanderbilt University Department of Neurology|