Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
Status:
Completed
Trial end date:
2004-04-01
Target enrollment:
Participant gender:
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, 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.