# Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia

> **NCT00313885** · PHASE2 · COMPLETED · sponsor: **Sanofi** · enrollment: 205 (actual)

## Conditions studied

- Fibromyalgia
- Sleep
- Chronic Pain

## Interventions

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

## Key facts

- **NCT ID:** NCT00313885
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2004-04
- **Primary completion:** 2005-06
- **Final completion:** 2005-06
- **Target enrollment:** 205 (ACTUAL)
- **Last updated:** 2010-11-30


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00313885

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00313885, "Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia". Retrieved via AI Analytics 2026-06-04 from https://api.ai-analytics.org/clinical/NCT00313885. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
