Conditions: Fibromyalgia
Keywords: FMS Fibro pain Body pain tenderness stiffness muscular pain joint pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 573
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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-two (22) 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 a two week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication up to 4 grams per day of acetaminophen (paracetemol) will be allowed.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: placebo intervention 2: Xyrem®
Intervention descriptions: intervention 1: Oral Solution intervention 2: two doses

Protocol document: