Levetiracetam for Treatment of Pain Associated With Fibromyalgia
This study has been completed.
Sponsor:
University of California, San Francisco
Collaborator:
UCB, Inc.
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00254657
First received: November 15, 2005
Last updated: May 10, 2013
Last verified: May 2013
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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 Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Trial of Levetiracetam for Treatment of Pain Associated With Fibromyalgia |
Resource links provided by NLM:
MedlinePlus related topics:
Fibromyalgia
Drug Information available for:
Levetiracetam
U.S. FDA Resources
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- 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") [ Time Frame: Baseline to final week of treatment ]
Secondary Outcome Measures:
- 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" [ Time Frame: Baseline to final week of treatment ] [ Designated as safety issue: No ]Change from mean score during baseline week to mean score during final week of treatment before tapering period began
- Fibromyalgia Impact Questionnaire [ Time Frame: Baseline to final week of treatment ]10-item, self-administered instrument designed to assess impact of fibromyalgia on physical functioning, work, fatigue, stiffness, anxiety and depression
- Fibromyalgia Pain Now as measured using handheld 0-100 mm pain VAS (0 mm = "No pain" and 100 mm = "Worst pain imaginable" [ Time Frame: Baseline to final week of treatment ]
- Short-Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Baseline to final week of treatment ]Part 1: Fibromyalgia pain severity over past 7 days rate on 0-100 mm VAS; Part 2: Present pain intensity - 6 item category rating of pain "right now"; Part 3: Fifteen pain descriptors rated over past 7 days using 4 point intensity score (0= none to 3 = severe) and summed into sensory score and affective score
- Fibromyalgia tender point score [ Time Frame: Baseline to final week of treatment ]Number of days with headache in past 2 weeks reported (0=no headache; 1=1-2 days; 2=3-5 days; 3=6-9 days; 4=10-13 days; 5=headache all 14 days) and average headache severity rated on 0-10 NRS
- Patient and Clinician Global Impression of Change [ Time Frame: Final week of treatment ]Impression of change rated independently by subject and clinician on 1-7 category scale (1="very much improved", 2="much improved", 3="improved", 4="no change", 5="worse", 6="much worse", 7="very much worse"
- Fibromyalgia tender point score [ Time Frame: Baseline to end of treatment ]Manual Tender Point Survey with each site rated on 0-10 scale (0="no pain" and 10="worst pain imaginable"); "Fibromyalgia intensity score" represents mean sensitivity of 18 standardized tender point sites and "Control intensity score" represents mean sensitivity of 3 control sites
| Enrollment: | 66 |
| Study Start Date: | March 2004 |
| Study Completion Date: | April 2005 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo | Drug: Placebo |
| Experimental: Levetiracetam |
Drug: Levetiracetam
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.
Other Name: Keppra
|
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:
- 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.
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, Inc.
Investigators
| Principal Investigator: | Michael C Rowbotham, MD | University of California, San Francisco |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00254657 History of Changes |
| Other Study ID Numbers: | H5612-23162 |
| Study First Received: | November 15, 2005 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
Fibromyalgia Fibro Keppra Levetiracetam |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Etiracetam Piracetam |
Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013