Conditions: Fibromyalgia
Keywords: Fibromyalgia Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 195
Healthy volunteers: no

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.

Arms:
arm 1: Sodium oxybate 6.0 g per day. arm 2: Placebo (one of two doses matching active treatment by volume). arm 3: Sodium oxybate 4.5 g per day.

Interventions: intervention 1: Xyrem (sodium oxybate) oral solution intervention 2: Xyrem (sodium oxybate) oral solution intervention 3: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: Placebo one of two doses matching active treatment by volume for 8 weeks.

Protocol document: