A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: placebo
* Drug: Xyrem®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia. Exclusion Criteria: Subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms. Any other condition that will cause a risk to subjects if they participate in the trial is also a reason for exclusion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: placebo<br>* Oral Solution<br>|
| Experimental: 2<br> | Drug: Xyrem®<br>* two doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Week 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FMS, Fibro, pain, Body pain, tenderness, stiffness, muscular pain, joint pain