Trial intelligence / Profile preview

Eplivanserin for Sleep Disorders in Fibromyalgia

NCT00313885Phase 2

Key facts

Status: Completed
Start: Apr 2004
Primary completion: Jun 2005
Countries: 2
Sponsor: Sanofi
Modality: Small Molecules

Drugs: eplivanserin
Conditions: fibromyalgia (FM)sleep disorder

Overview

Phase 2, randomised, double-blind trial of eplivanserin in fibromyalgia (FM) and sleep disorder (3 arms), sponsored by Sanofi. Primary endpoint: Refreshing quality of sleep measured by the patient sleep questionnaire at 8 weeks. Started Apr 2004; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

1 mg eplivanserin
Experimental arm receiving 1 mg daily
5 mg eplivanserin
Experimental arm receiving 5 mg daily
Placebo
Control arm receiving placebo daily

Who it enrols

Patients must meet ACR criteria for fibromyalgia and report unrefreshing sleep at least 3 nights per week. Excludes heavy caffeine users, night shift workers, and frequent nappers.

Endpoints

Primary

Refreshing quality of sleep measured by the patient sleep questionnaire8 weeks

Secondary

Sleep maintenance8 weeks
Sleep duration8 weeks
Sleep induction8 weeks
Sleep quality8 weeks

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