Treatment Studies
Xyrem - Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia
Study Drug: Xyrem (sodium oxybate)
Sponsor: Jazz Pharmaceuticals, the maker of Xryem
FDA Status: This medication is approved for the treatment of narcolepsy, a sleep disorder that produces excessive daytime sleepiness. It is classified by the DEA as a schedule III drug.
Basic Info: Xyrem is suspected to work by increasing deep level sleep, raising pain-fighting neurotransmitters and opioids in the central nervous system, and increasing growth hormone, but this information is based on data in people with narcolepsy. The drug being studied comes in liquid and tablet forms.
Recruiting for Phase III Trial: This safety and tolerability study is comparing sodium oxybate given as an oral solution to a single-blinded combination of oral tablets plus oral solution in fibromyalgia patients over four weeks. Xyrem is currently being tested at 25 locations in 14 states. Patients will be asked to take one of four experimental doses of sodium oxybate: 4.5 grams per night taken in two equally divided doses; 4.5 grams taken as a combination of liquid and 6 tablets in two equally divided doses per night; 6 grams per night taken in two equally divided doses; or 6 grams taken as a combination of liquid and 8 tablets in two equally divided doses per night
Previous Test Results: During 2004-2005, Xyrem was tested in 20 treatment centers in the United States. This Phase II trial involved 188 FM patients and evaluated three different doses to determine which one worked best. More importantly, the FDA required that the drug not only improve sleep and reduce fatigue in FMS, but it also had to significantly improve pain ... and it did by an average of 35 percent. Understand that an average means that some people improved significantly while many others did not. During the first part of Phase III testing, 1,050 patients were evaluated in 2008-09.
Study Criteria (key requirements):
- must meet the diagnostic criteria for fibromyalgia syndrome
- male or female, 18 years or older
- may be using only non-sedating over-the-counter (OTC) medication
- must be located within a reasonable driving distance of a treatment center
- must not have with sleep apnea
- has not been involved in a previous Xyrem (sodium oxybate) trial
Study Locations: You can click on the following link to read more:
The Fibromyalgia Network is not in any way associated with any clinical trials, pharmaceutical companies, device manufacturers, or government agencies. As a self-help organization, we accept no sponsorship, advertisements, or government funds. The information on these pages is provided as a public service.
Back to Treatment Studies
