The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.
The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-one (21) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined, followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by one (1) week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication acetaminophen (up to 4 grams per day) will be allowed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
548
Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).
Percentage of pain VAS responders. Subjects with a \>= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.
Time frame: Baseline to Week 14
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Rheumatology Associates of N. AL, PC
Huntsville, Alabama, United States
Xenoscience, Inc. dba 21st Century Neurology
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Providence Clinical Research
Burbank, California, United States
Northern California Research
Carmichael, California, United States
Pasadena Rehabilitation Institute
Pasadena, California, United States
Arroyo Medical Group
Pismo Beach, California, United States
Sacramento Research Medical Group
Sacramento, California, United States
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