Xyrem Clinical Trial Information
View some of the current sites recruiting for clinical trials of Xyrem® (sodium oxybate) oral solution.

NARCOLEPSY CLINICAL TRIAL ANNOUNCEMENT

1. Title:
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem® (sodium oxybate) with Placebo for the Treatment of Narcolepsy

2. Purpose of the study:
The purpose of this medical research study is to evaluate the safety and effectiveness of an investigational drug for controlling the symptoms of narcolepsy. Narcolepsy is a chronic neurologic disorder characterized by severe sleepiness, and in most cases, giving way or twitching of muscles when laughing hard, excited, agitated, or surprised. In addition, narcoleptic individuals may sometimes be unable to move their limbs, trunk, neck and face when they awaken and they may experience dream-like images or other hallucinations when they are in the transition between wakefulness and sleep. Participants will be asked to evaluate changes in their symptoms of narcolepsy.

3. Protocol summary:
The initial portion of the protocol involves discontinuing any medications for cataplexy that the patient may be taking. Subsequently the patient is prescribed a dose of oral solution of study drug or placebo over a 10 ­ 11 week period. During the trial, your narcolepsy symptoms will be evaluated. Participants are allowed to continue using stimulant medications at constant doses during the study. A total of 1 to 3 daytime visits in addition to 4 overnight visits to the sleep center will be required to complete the study.

4. Basic eligibility criteria:
Potential candidates for the trial will have a history of and current symptoms of excessive daytime sleepiness, a history of cataplexy, or a diagnosis of narcolepsy. Patients will not be considered for the trial if they have been diagnosed with severe sleep apnea or restless-leg syndrome, are taking anticonvulsants, have significant or unstable physical or psychiatric condition, or work evenings/nights.

5. How to contact a site for further information:
Additional Investigators can be identified by contacting Orphan Medical, Inc. pservices@orphan.com or 1-888-8ORPHAN (1-888-867-7426).

Investigators and coordinators can be identified by telephone or by e-mail: