At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 560 enrolled
Drug / intervention
Xyrem®drug
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 Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
In Brief
A Phase 3 clinical trial evaluating Xyrem® for Fibromyalgia. Completed, enrolled 560 participants across 91 sites in 7 countries.
Detailed Summary
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesFrance, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedJan 2007
Primary CompletionJan 2010
TodayJul 2026
First PostedJan 18, 2007
Enrollment StartDec 1, 2006
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 19.5 years ago
Interventions
Xyrem®drug
flexible dosing