Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-04 @ 4:14 PM
Study NCT ID:
NCT00253903
Status:
COMPLETED
Last Update Posted:
2010-11-30
First Post:
2005-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year
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 Followed by an Open Treatment Phase Extension With Eplivanserin for a 40-week Period
Status:
COMPLETED
Status Verified Date:
2010-11
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:
EPLILONG
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:
The study is being conducted worldwide.
It consists of 4 segments:
* Segment A: 7-day run-in (screening)
* Segment B: 12-week double blind treatment
* Segment C: 40-week open treatment extension
* Segment D: 2-week run-out period
It consists of 4 segments:
* Segment A: 7-day run-in (screening)
* Segment B: 12-week double blind treatment
* Segment C: 40-week open treatment extension
* Segment D: 2-week run-out period
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EucraCT: 2005-003082-16 | None | None | View |