NCT00313885 is a Phase 2 clinical trial of eplivanserin (SR46349) in Fibromyalgia, sponsored by Sanofi.

Who is sponsoring NCT00313885?

NCT00313885 is sponsored by Sanofi.

What drugs are being tested in NCT00313885?

Interventions in NCT00313885: eplivanserin (SR46349), placebo.

What condition does NCT00313885 study?

NCT00313885 studies Fibromyalgia, Sleep, Chronic Pain.

Is NCT00313885 still recruiting?

NCT00313885 is currently completed. Last updated 29 November 2010.

Last reviewed 2010-11-29 · How we verify

NCT00313885

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of SR46349B (1 and 5mg/Day) Administered During 8 Weeks in Patients With Sleep Disorders in Fibromyalgia: Multi-center, Randomized, Double-blind, Placebo-controlled Study.

Completed Phase 2 Last updated 29 November 2010

What this trial tests

Phase 2 trial testing eplivanserin (SR46349) in Fibromyalgia in 205 participants. Completed in 1 June 2005.

Timeline

1 April 2004

Primary endpoint
1 June 2005

1 June 2005

Quick facts

Lead sponsor	Sanofi
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	205
Start date	1 April 2004
Primary completion	1 June 2005
Estimated completion	1 June 2005
Sites	12 locations across United States, Canada

Drugs / interventions tested

eplivanserin (SR46349) — full drug profile →
placebo

Conditions studied

Fibromyalgia — all drugs for Fibromyalgia →
Sleep — all drugs for Sleep →
Chronic Pain — all drugs for Chronic Pain →

Sponsor

Sanofi — full company profile →

Who can join

Adults 18 to 64, any sex, with Fibromyalgia or Sleep. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

refreshing quality of sleep measured by the patient sleep questionnaire
Time frame: 8 weeks

Sponsor's own description

Fibromyalgics frequently report sleep disturbances, in particular poor and unrefreshing sleep. Additionally, studies have reported that sleep problems, pain and mood disturbances are associated in patients with fibromyalgia. By improving the quality of sleep, complaints of poor and unrefreshing sleep, fatigue, pain, which are among the main components of this chronic pain disorder may be improved.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Fibromyalgia

Currently open trials in the same condition.

NCT02285868 — ATI Evidence-based Guide Investigating Clinical Services · active not recruiting
NCT07245303 — Neural Mechanisms of Light Driven Analgesia · NA · recruiting
NCT05901259 — The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes · recruiting
NCT07358754 — The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor · recruiting
NCT07465991 — The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia · NA · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00313885 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 29 November 2010

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00313885.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing