NCT00805350 (ECLIPSE) is a Phase 3 clinical trial of Eplivanserin in Primary Insomnia, sponsored by Sanofi.

Who is sponsoring NCT00805350?

NCT00805350 is sponsored by Sanofi.

What drugs are being tested in NCT00805350?

Interventions in NCT00805350: Eplivanserin, Placebo.

What condition does NCT00805350 study?

NCT00805350 studies Primary Insomnia.

Is NCT00805350 still recruiting?

NCT00805350 is currently completed. Last updated 5 February 2016.

Last reviewed 2016-02-05 · How we verify

NCT00805350: ECLIPSE

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

Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties: a 6-week, Randomized, Double-blind, Placebo-controlled, Polysomnography Study.

Completed Phase 3 Last updated 5 February 2016

What this trial tests

Phase 3 trial testing Eplivanserin in Primary Insomnia in 637 participants. Completed in 1 June 2009.

Timeline

1 December 2008

Primary endpoint
1 June 2009

1 June 2009

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	637
Start date	1 December 2008
Primary completion	1 June 2009
Estimated completion	1 June 2009
Sites	7 locations across United States, Austria, Canada, France, Germany, Hungary, Poland

Drugs / interventions tested

Eplivanserin — full drug profile →
Placebo

Conditions studied

Primary Insomnia — all drugs for Primary Insomnia →

Sponsor

Sanofi — full company profile →

Who can join

18 and older, any sex, with Primary Insomnia. 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.

Change from baseline of mean PSG-WASO on N41/N42
Time frame: 6 weeks
Change from baseline of mean PSG-NAW on N41/N42
Time frame: 6 weeks

Sponsor's own description

Primary objective: \- To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients, as measured by Polysomnography Wake Time After Sleep Onset (PSG-WASO) and Polysomnography Number of Awakenings (PSG-NAW). Secondary objectives: * To evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of treatment on other sleep parameters measured by PSG recordings (Total Sleep Time - PSG-TST, Sleep Efficiency - PSG-SE, Latency to Persistent Sleep - PSG-LPS) and reported by patients (Wake Time After Sleep Onset - pr-WASO, Number of Awakenings - pr-NAW, Total Sleep Time - pr-TST, Quality of Sleep - QoS and Refreshing Quality of Sleep - RqoS). * To evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to placebo. * To evaluate the effect of eplivanserin 5mg/day on daytime functioning using the Sleep Impact Scale (SIS), as compared with placebo after 6 weeks of treatment. * To evaluate patient's impression of treatment effects using the Patient's Global Impression questionnaire. * To evaluate the potential for next-day residual effects (using patient's morning questionnaire and psychometric tests) with eplivanserin 5mg/day as compared to placebo. * To evaluate the potential for rebound insomnia following abrupt discontinuation of eplivanserin 5mg/day in comparison with placebo. * To evaluate the effect of eplivanserin, compared to placebo, on the quality of life of patients with primary insomnia using the SF-36 Health Survey. * To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo.

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 Primary Insomnia

Currently open trials in the same condition.

NCT06996171 — Comparative Efficacy of Magnesium Supplement and Melatonin Congener in Young Adults With Primary Insomnia · NA · recruiting
NCT06782815 — Acupoint Selection Based on Meridian Theory in Primary Insomnia of Liver Depression and Spleen Deficiency Type · NA · recruiting
NCT05830877 — The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia · 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 NCT00805350 (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: 5 February 2016

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/NCT00805350.

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