Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
Completed
Orphan Medical
Phase 3
2000-12-01
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, 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.
Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
Completed
Jazz Pharmaceuticals
Phase 3
2003-04-01
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled,
parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be
required to make 5 visits over up to 14 weeks to a participating expert physician
practitioner for various sleep and narcolepsy evaluations and diaries will also be collected.
Participants will take assigned medications during the course of the trial. Subjects will
have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject
volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness.
Patients will not incur any personal medical expenses due to participation in this trial. The
sponsor is covering all visit costs not covered by insurance and there are some funds for
patient expenses such as travel.
Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients
Completed
Jazz Pharmaceuticals
Phase 4
2003-11-01
To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the
morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and
outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea
syndrome (OSAS).
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