Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253968
Status:
COMPLETED
Last Update Posted:
2016-03-01
First Post:
2005-11-14
Brief Title:
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Efficacy and Safety of Eplivanserin 5mgDay 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:
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-003080-23 | EUDRACT_NUMBER | None | None |