Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Drug: Placebo
- Registration Number
- NCT00087555
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief 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.
- Detailed Description
Fibromyalgia affects millions of Americans, yet there are no FDA approved drugs to treat this debilitating condition. Besides causing pain, it also disrupts normal sleep patterns in many of its victims. Pain and lack of sleep reinforce each other, making patients progressively more miserable. Xyrem is a potent hypnotic that induces and consolidates sleep. In a few small studies Xyrem has been reported to offer relief to some fibromyalgia patients. This trial is designed to test this hypothesis. Patients who enroll in this study will stop taking any prescription medications for fibromyalgia (over-the-counter pain relievers will be permitted). They will then take either Xyrem alone or placebo alone. Patients will be followed for eight weeks to evaluate any relief of the pain or functional impairment of fibromyalgia from their study treatment. Sleep characteristics will also be assessed subjectively and by polysomnographic recordings at baseline and twice during the treatment phase.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Xyrem (sodium oxybate) oral solution Sodium oxybate 4.5 g per day. 2 Xyrem (sodium oxybate) oral solution Sodium oxybate 6.0 g per day. 3 Placebo Placebo (one of two doses matching active treatment by volume).
- Primary Outcome Measures
Name Time Method The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C). Baseline to week 8 The percentage of participants who met all 3 of the following criteria:
Reduction of \>=20% from baseline to week 8 in both PVAS \& FIQ total score and PGI-C response of "very much better" or "much better". Analysis was based on LOCF (Last Observation Carried Forward) data. The PVAS ranges from 0 (no pain) to 100 (worst imaginable pain). The FIQ ranges from 0 (best function) to 100 (worst function). PGI-C is a 7 point likert scale measuring change in the participant's fibromyalgia symptoms that ranges from "very much worse" to "very much better"
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Wallace Rheumatic Study Center
🇺🇸Los Angeles, California, United States
Radiant Research, Inc.
🇺🇸West Palm Beach, Florida, United States
C.A.R.E. Center
🇺🇸Raleigh, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Central Kentucky Research Associates, Inc.
🇺🇸Lexington, Kentucky, United States
Alvin Daughtridge Arthritis Center
🇺🇸Lenoir, North Carolina, United States
Cleveland Sleep Center
🇺🇸Middlebrook Heights, Ohio, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Abigail Rebecca Neiman, MD
🇺🇸Katy, Texas, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Stress Medicine Clinic -- HealthSouth Rehabilitation Hospital
🇺🇸Sandy, Utah, United States
Pacific Rheumatology Research, Inc.
🇺🇸Renton, Washington, United States
Seattle Rheumatology Associates
🇺🇸Seattle, Washington, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Osteoporosis Medical Center
🇺🇸Beverly Hills, California, United States
Richard N. Podell, MD
🇺🇸Springfield, New Jersey, United States
Radiant Research
🇺🇸Scottsdale, Arizona, United States