Trials / Completed
CompletedNCT00049803
Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (planned)
- Sponsor
- Orphan Medical · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sodium oxybate |
Timeline
- Start date
- 2000-12-01
- Completion
- 2004-04-01
- First posted
- 2002-11-15
- Last updated
- 2005-06-24
Locations
45 sites across 3 countries: United States, Canada, Switzerland
Source: ClinicalTrials.gov record NCT00049803. Inclusion in this directory is not an endorsement.