# Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year

> **NCT00253903** · PHASE3 · COMPLETED · sponsor: **Sanofi** · enrollment: 1155 (actual)

## Conditions studied

- Sleep Initiation and Maintenance Disorders
- Insomnia

## Interventions

- **DRUG:** eplivanserin (SR46349)
- **DRUG:** placebo

## Key facts

- **NCT ID:** NCT00253903
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2005-11
- **Primary completion:** 2007-11
- **Final completion:** 2008-09
- **Target enrollment:** 1155 (ACTUAL)
- **Last updated:** 2010-11-30


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00253903

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00253903, "Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year". Retrieved via AI Analytics 2026-07-08 from https://api.ai-analytics.org/clinical/NCT00253903. Licensed CC0.

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