May 2: Belgian investigators at University Hospital, Ghent, have announced they’re preparing to enroll about 65 patients with chronic fatigue syndrome (ME/CFS) but without fibromyalgia in a placebo controlled, randomized, double blind, cross-over efficacy trial of the experimental drug sodium oxybate (Xyrem). They apparently expect to launch in June.
Sodium oxybate is a short-acting central nervous system depressant that has gained publicity for its abuse as “the date-rape drug.” It is FDA approved to prevent episodes of cataplexy (sudden episodes of muscle weakness) or narcolepsy (sudden uncontrollable episodes of sleep during day). Currently a costly drug, physicians have tried it off-label for treatment of ME/CFS sleep & fatigue, and it has shown some promise in trials for treatment of fibromyalgia insomnia, fatigue and pain; but so far with questionable promise of FDA approval for the fibromyalgia diagnosis.
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The primary outcome measure in the Belgian trial will be effect on fatigue in ME/CFS. Secondary measures, sleepiness, sleep quality, general health, and pain. The researchers suggest the findings may support a better understanding of “the enigmatic relationship between sleep and fatigue.”
According to principal investigator An Mariman, MD, both the subjects receiving sodium oxybate and the group receiving placebo (fake medication) will be treated in their home with varying amounts of medication each night over a period of weeks.
For details and inclusion/exclusion criteria, see the study’s ClinicalTrials.gov description – http://clinicaltrials.gov/ct2/show/NCT01584934.
For questions, e-mail principal investigator An Mariman, MD: An.Mariman@ugent.be