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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00280280 |
The purposes of this pilot study are to evaluate the safety and efficacy of Botox® compared to the safety and efficacy of oral baclofen in reducing muscle tone-related disability resulting from neurological damage or a stable neurological disorder and to evaluate drug-therapy tolerance.
Condition | Intervention | Phase |
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Spasticity |
Drug: intramuscular Botox versus oral baclofen |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind Comparison of Botox Versus Baclofen for the Treatment of Subjects With Upper Limb Spasticity - Pilot Study |
Estimated Enrollment: | 30 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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.
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232-2551 |
Principal Investigator: | P. David Charles, MD | Vanderbilt University Department of Neurology |
Responsible Party: | Vanderbilt University ( David Charles ) |
Study ID Numbers: | 050935 |
Study First Received: | January 18, 2006 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00280280 History of Changes |
Health Authority: | United States: Institutional Review Board |
spasticity Botox baclofen |
Neurotransmitter Agents Baclofen Signs and Symptoms Muscle Spasticity Muscular Diseases Botulinum Toxins Musculoskeletal Diseases |
Muscle Hypertonia Muscle Relaxants, Central GABA Agonists Povidone Neurologic Manifestations Peripheral Nervous System Agents Botulinum Toxin Type A |
Neuromuscular Manifestations Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Baclofen Physiological Effects of Drugs Neuromuscular Agents Pharmacologic Actions Signs and Symptoms Muscle Spasticity Muscular Diseases |
Musculoskeletal Diseases Muscle Hypertonia GABA Agonists Therapeutic Uses Muscle Relaxants, Central GABA Agents Neurologic Manifestations Peripheral Nervous System Agents Botulinum Toxin Type A Central Nervous System Agents |