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Sponsors and Collaborators: |
University of California, San Francisco UCB |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00254657 |
The purpose of this study is to assess the safety and effectiveness of levetiracetam in reducing the pain of fibromyalgia when compared to placebo.
Levetiracetam, an anti-seizure drug, is currently FDA-approved and marketed for use in patients with seizures. Levetiracetam may relieve pain by reducing abnormal activity in the nervous system. A placebo is an inactive substance.
Condition | Intervention |
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Fibromyalgia |
Drug: Levetiracetam |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Trial of Levetiracetam for Treatment of Pain Associated With Fibromyalgia |
Estimated Enrollment: | 80 |
Study Start Date: | March 2004 |
The UCSF Pain Clinical Research Center (PCRC) will be conducting this investigator-initiated 9-week, randomized, double-blind, placebo-controlled, parallel group study of Levetiracetam. There will be a total of 6 study visits. Visit 1 is a screening visit to assess subject eligibility, followed by a one-week period of baseline daily pain and sleep assessments. Visit 2 (one week after Visit 1) subjects will be randomized in a 3/2-randomization scheme and administered study medication. Subjects randomized to the treatment group will start Levetiracetam at 1 tablet of 500/mg/day, and will titrate by 500mg each week to a maximum dose of 3000 mg/day. Visits 3, 4, 5, and 6 (occurring 2, 4, 6 and 8 weeks after started study drug) include safety and efficacy assessments. Study drug taper is initiated at Visit 6.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSF | |
San Francisco, California, United States, 94115 |
Principal Investigator: | Michael C Rowbotham, MD | University of California, San Francisco |
Study ID Numbers: | H5612-23162 |
Study First Received: | November 15, 2005 |
Last Updated: | February 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00254657 History of Changes |
Health Authority: | United States: Institutional Review Board |
Fibromyalgia Fibro Keppra Levetiracetam |
Nootropic Agents Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Fibromyalgia |
Piracetam Etiracetam Pain Rheumatic Diseases Neuroprotective Agents Anticonvulsants |
Nootropic Agents Fibromyalgia Myofascial Pain Syndromes Physiological Effects of Drugs Nervous System Diseases Rheumatic Diseases Protective Agents Neuroprotective Agents Pharmacologic Actions |
Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Therapeutic Uses Piracetam Etiracetam Central Nervous System Agents Anticonvulsants |