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Levetiracetam for Treatment of Pain Associated With Fibromyalgia
This study has been completed.
First Received: November 15, 2005   Last Updated: February 8, 2008   History of Changes
Sponsors and Collaborators: University of California, San Francisco
UCB
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00254657
  Purpose

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
Fibromyalgia
Drug: Levetiracetam

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Levetiracetam
U.S. FDA Resources
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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • The change in average daily pain score from the baseline week to the final week of treatment before taper begins, as recorded in subjects' daily pain diaries and measured on an 11-point Likert scale having as endpoints 0 ("no pain") and 10 ("worst

Secondary Outcome Measures:
  • Secondary parameters include the sleep rating, which will also be rated on an 11-point Likert scale, the Short Form McGill Pain Questionnaire (SF-MPQ), the Fibromyalgia Impact Questionnaire, the Headache Questionnaire, the Subjects' Global Impression of

Estimated Enrollment: 80
Study Start Date: March 2004
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female 18 years of age or older.
  2. Subjects must meet the 1990 American College of Rheumatology Criteria for the diagnosis of Fibromyalgia Syndrome.
  3. 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.
  4. Subjects must complete at least 4 diaries during the 7 days prior to randomization.
  5. 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.
  6. Ability to understand and follow the instructions of the investigator, including completion of the study diaries as described in the protocol.
  7. Ability to provide informed written consent.

Exclusion Criteria:

  1. Subjects who have demonstrated a hypersensitivity to levetiracetam or who have been previously treated with it.
  2. Subjects with severe liver or kidney insufficiency (AST, ALT, BUN, Creatinine more than twice the upper limit of the reference range).
  3. Abnormal Westergen erythrocyte sedimentation rate (e.g. ESR >40 mm/min)
  4. Abnormal antinuclear antibody (ANA≥1:160), or rheumatoid factor (RF>80 IU/ml)
  5. Subjects with significant hematological disease, such as clotting disorders.
  6. Subjects who have undergone trigger point injections or other needle-based therapies in the two weeks prior to dosing.
  7. Subjects having other severe pain that may confound assessment of the pain due to the fibromyalgia.
  8. 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.
  9. Subjects who have a history of illicit drug or alcohol abuse within the last year.
  10. Pregnant or lactating women.
  11. Subjects who are considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators
  12. 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.
  13. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254657

Locations
United States, California
UCSF
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
UCB
Investigators
Principal Investigator: Michael C Rowbotham, MD University of California, San Francisco
  More Information

No publications provided

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

Keywords provided by University of California, San Francisco:
Fibromyalgia
Fibro
Keppra
Levetiracetam

Study placed in the following topic categories:
Nootropic Agents
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Fibromyalgia
Piracetam
Etiracetam
Pain
Rheumatic Diseases
Neuroprotective Agents
Anticonvulsants

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009