Status:
COMPLETED
Levetiracetam for Treatment of Pain Associated With Fibromyalgia
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
UCB Pharma
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 FD...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Male or female 18 years of age or older.
- Subjects must meet the 1990 American College of Rheumatology Criteria for the diagnosis of Fibromyalgia Syndrome.
- Subjects at screening must have an average score of at least 40mm on the Visual Analog Scale (VAS) of the SF-McGill Pain Questionnaire; and at baseline must have an average score of at least 4/10 over the last 7 days on the Daily Pain Rating Scale.
- Subjects must complete at least 4 diaries during the 7 days prior to randomization.
- Subjects must discontinue use of steroids, muscle relaxants, anticonvulsants, sodium channel blockers, topical analgesics, and needle-based therapies, including trigger point injections and acupuncture, at least 1 week prior to starting study medication and agree to stay off such therapies throughout the study. Continuation of nonsteroidal anti-inflammatories, antidepressants and opiates are allowed, provided they have reached a stable dose prior to study entry and maintain a stable dose throughout the study.
- Ability to understand and follow the instructions of the investigator, including completion of the study diaries as described in the protocol.
- Ability to provide informed written consent.
Exclusion
- Subjects who have demonstrated a hypersensitivity to levetiracetam or who have been previously treated with it.
- Subjects with severe liver or kidney insufficiency (AST, ALT, BUN, Creatinine more than twice the upper limit of the reference range).
- Abnormal Westergen erythrocyte sedimentation rate (e.g. ESR \>40 mm/min)
- Abnormal antinuclear antibody (ANA≥1:160), or rheumatoid factor (RF\>80 IU/ml)
- Subjects with significant hematological disease, such as clotting disorders.
- Subjects who have undergone trigger point injections or other needle-based therapies in the two weeks prior to dosing.
- Subjects having other severe pain that may confound assessment of the pain due to the fibromyalgia.
- Subjects taking or having taken any other experimental drugs, drugs not approved in the United States, or participating in or having participated in other clinical studies in the 2 months prior to this clinical trial.
- Subjects who have a history of illicit drug or alcohol abuse within the last year.
- Pregnant or lactating women.
- Subjects who are considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators
- Subjects who have serious or unstable medical or psychological conditions that in the opinion of the investigator(s), would compromise the subject's participation in the study.
- Subjects involved in any unsettled litigation such as automobile accident, civil lawsuit, or worker's compensation pertaining to their fibromyalgia, current involvement in out-of-court settlements for litigation pertinent to their fibromyalgia, or are currently receiving monetary compensation as a result of any of the above.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00254657
Start Date
March 1 2004
End Date
April 1 2005
Last Update
May 13 2013
Active Locations (1)
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1
UCSF
San Francisco, California, United States, 94115