At a glance
ClinicalIndex Comparison Record- ✓Age >18 years
- ✓Meet American College of Rheumatology criteria for fibromyalgia with widespread pain ≥3 months involving bilateral, above/below waist, axial sites, and ≥11 of 18 tender points on digital palpation
- ✓VAS pain score >4 at baseline (study continuation criterion)
- ✓Willing to discontinue all fibromyalgia medications (opioids, benzodiazepines, anticonvulsants for pain, antidepressants, cyclobenzaprine, tramadol)
- ✕Other rheumatic diseases (rheumatoid arthritis, osteoarthritis, SLE)
- ✕Uncontrolled thyroid disease
- ✕Myocardial infarction within 6 months
- ✕Sleep apnea with Apnea Index >10/hour or Apnea Hypopnea Index >15/hour (unless controlled on CPAP)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem(R) (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia
In Brief
A Phase 2 clinical trial evaluating Xyrem (sodium oxybate) oral solution and Placebo for Fibromyalgia. Completed, enrolled 195 participants across 20 sites.
Detailed Summary
The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia.
Study Details
Timeline
Interventions
Xyrem (sodium oxybate) oral solution 4.5 g per day in divided doses, 2.25 g at bedtime and another 2.5 g two and a half to four hours later for 8 weeks.
Xyrem (sodium oxybate) oral solution 6.0 g per night in divided doses of 3 g at bedtime and 3 g at 2.5 to 4 hours later for 8 weeks.
Placebo one of two doses matching active treatment by volume for 8 weeks.