Levetiracetam for Treatment of Pain Associated With Fibromyalgia
Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibromyalgia
Intervention: Levetiracetam (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s): Michael C Rowbotham, MD, Principal Investigator, Affiliation: University of California, San Francisco
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 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.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Levetiracetam for Treatment of Pain Associated With Fibromyalgia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Weekly mean of average daily pain score as recorded in subjects' daily pain diaries and measured on an 11-point Likert scale with endpoints 0 ("no pain") and 10 ("worst pain")
Secondary outcome: Sleep Interference over the past 24 hours as recorded in daily sleep diary on 11-point Likert scale (0 = "pain does not interfere with sleep" to 10 = "pain completely interferes with sleep"Fibromyalgia Impact Questionnaire Fibromyalgia Pain Now as measured using handheld 0-100 mm pain VAS (0 mm = "No pain" and 100 mm = "Worst pain imaginable" Short-Form McGill Pain Questionnaire (SF-MPQ) Fibromyalgia tender point score Patient and Clinician Global Impression of Change Fibromyalgia tender point score
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
UCSF, San Francisco, California 94115, United States
Additional Information
Starting date: March 2004
Last updated: May 10, 2013
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