At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 548 enrolled
Drug / intervention
Xyrem® +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
In Brief
A Phase 3 clinical trial evaluating Xyrem® and Placebo for Fibromyalgia. Completed, enrolled 548 participants across 70 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
First PostedSep 2006
Primary CompletionSep 2008
Study CompletionDec 2008
TodayJul 2026
First PostedSep 1, 2006
Enrollment StartAug 1, 2006
Primary CompletionSep 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.8 years ago
Interventions
Xyrem®drug
two doses
Placebodrug
Oral Solution