Conditions: Fibromyalgia
Keywords: FMS Fibro pain Body pain tenderness joint pain stiffness muscular pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 548
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-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.

Arms:
arm 1: None arm 2: None

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

Protocol document: