Levetiracetam for Treatment of Pain Associated With Fibromyalgia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Trial of Levetiracetam for Treatment of Pain Associated With Fibromyalgia|
- 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 ]
- 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
|Study Start Date:||March 2004|
|Study Completion Date:||April 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||Drug: Placebo|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254657
|United States, California|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Michael C Rowbotham, MD||University of California, San Francisco|