Levetiracetam for Treatment of Pain Associated With Fibromyalgia

NCT00254657 | Completed

• 1 other identifier: H5612-23162
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Fibro; Keppra; Levetiracetam

Outcome Measures

Primary Outcomes (1)

• 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")

  Baseline to final week of treatment

Secondary Outcomes (7)

• 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"

  Baseline to final week of treatment

• Fibromyalgia Impact Questionnaire

  Baseline to final week of treatment

• Fibromyalgia Pain Now as measured using handheld 0-100 mm pain VAS (0 mm = "No pain" and 100 mm = "Worst pain imaginable"

  Baseline to final week of treatment

• Short-Form McGill Pain Questionnaire (SF-MPQ)

  Baseline to final week of treatment

• Fibromyalgia tender point score

  Baseline to final week of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Levetiracetam

EXPERIMENTAL

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

Started with one 500 mg tablet/day and titrated upward as tolerated over 6 weeks by 500 mg/week to a maximum dose of 3000 mg/day.

Also known as: Keppra

Levetiracetam

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• UCB Pharma: collaborator

Study Sites (1)

UCSF

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michael C Rowbotham, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 16, 2005
• Study Start: March 1, 2004
• Primary Completion: March 1, 2005
• Study Completion: April 1, 2005
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

US (1)