Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT00253903
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
Study:
NCT00253903
Study Brief:
Protocol Section:
NCT00253903