Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-29 @ 4:59 PM
Study NCT ID:
NCT00253968
Status:
COMPLETED
Last Update Posted:
2016-03-01
First Post:
2005-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study
Status:
COMPLETED
Status Verified Date:
2016-02
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:
GEMS
Brief Summary:
The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.
Detailed Description:
12 weeks for each patient (double-blind period) + 1 week of run-in (placebo), and 2 weeks of run-out (placebo)
Total Duration of observation: 15 weeks for each patient
Total Duration of observation: 15 weeks for each patient
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2005-003080-23 | EUDRACT_NUMBER | None | View |