Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066170
Status:
COMPLETED
Last Update Posted:
2011-12-29
First Post:
2003-08-04
Brief Title:
Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
Sponsor:
Jazz Pharmaceuticals
Organization:
Jazz Pharmaceuticals
Study Overview
Official Title:
Randomized Double-Blind Double-Dummy Placebo-Controlled Parallel-Group Multi-Center Trial Comparing the Effects of Orally Administered Xyrem Sodium Oxybate and Modafinil With Placebo in Treatment of Daytime Sleepiness in Narcolepsy
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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