Treatment Studies
Xyrem - short and long-term trials
Studies to evaluate effectiveness of this drug for pain, sleep, and daytime fatigue.
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 is a liquid that must be taken at bedtime, and then again four hours later.
Recruiting for Phase III Trial: Two 14-week trials are placebo-controlled, blinded and randomized studies to evaluate effectiveness of this drug for treating the core symptoms of fibromyalgia (total participation time is estimated to be no more than 22 weeks to collect additional symptom information before and after the trial). Xyrem is being tested at 105 treatment centers in 31 states. During the first part of Phase III testing, 1,050 patients will be evaluated. One-third of the patients will receive a lower dose of Xyrem, one-third will receive a higher dose of the medication, and one-third will receive a placebo. Then patients who respond favorably or those who took the placebo will be given an opportunity to take Xyrem for nine and one-half months (this is the second part of the Phase III testing and there is no placebo group).
Previous Test Results: During 2004-2005, Xyrem was tested in 20 treatment centers in the United States. This Phase II trial involved 188 FMS 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%. Understand that an average means that some people improved significantly while many others did not.
Study Criteria (key requirements):
- must meet the diagnostic criteria for fibromyalgia syndrome
- male or female, 18 years or older
- cannot have other rheumatic diseases or disorders that produce similar symptoms of fibromyalgia because this would make it impossible for the study investigators to clearly determine if the drug is working for fibromyalgia
- must be able to go off all other medications except acetaminophen (Tylenol)
- must be willing to go through the first part of the placebo-controlled trial (meaning that you have a 33% chance of getting a placebo for 14 weeks) before you become eligible for the second part, which is the nine and one-half month Xyrem study
- must be located within a reasonable driving distance of a treatment center
Study Locations: Want to learn more about the Xyrem trials and treatment center locations? There are two different website listings for the first part of the Xyrem Phase III trial (placebo-controlled). You can click on the following two links to read more:
- A Safety and Efficacy Study of Xyrem in Subjects With Fibromyalgia
- A Safety and Efficacy Study of Xyrem (Sodium Oxybate) to Treat Fibromyalgia
To find out if you are near a treatment center for the nine and one-half month study (no placebo), click here. Note that some of the locations are not yet recruiting for this part of the study (probably because they have not completed the first part).
Related Trial: If you have chronic fatigue syndrome/myalgic encephalopathy (CFS/ME), but do not meet the criteria for fibromyalgia and you live near Newark, New Jersey, you may be interested in the Phase IV trial on Xyrem. Details can be found on the government’s Clinical Trials site by clicking here. This study documents that Xyrem is being evaluated for patients with the related condition of CFS/ME patients as well.
* Pardi D, Black J. CNS Drugs 20(12):993-1018, 2006.
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.
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