Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049803
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2002-11-13
Brief Title:
Safety and Efficacy of Xyrem Oral Solution Sodium Oxybate Compared With Placebo in Narcoleptic Patients
Sponsor:
Orphan Medical
Organization:
Orphan Medical
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2004-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None