Levetiracetam for Treatment of Pain Associated With Fibromyalgia

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.

Inclusion criteria

• 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 criteria

• 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.