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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
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.
UCSF
San Francisco, California, United States
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"
Change from mean score during baseline week to mean score during final week of treatment before tapering period began
Time frame: Baseline to final week of treatment
Fibromyalgia Impact Questionnaire
10-item, self-administered instrument designed to assess impact of fibromyalgia on physical functioning, work, fatigue, stiffness, anxiety and depression
Time frame: 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"
Time frame: Baseline to final week of treatment
Short-Form McGill Pain Questionnaire (SF-MPQ)
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
Time frame: Baseline to final week of treatment
Fibromyalgia tender point score
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
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Time frame: Baseline to final week of treatment
Patient and Clinician Global Impression of Change
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"
Time frame: Final week of treatment
Fibromyalgia tender point score
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
Time frame: Baseline to end of treatment