NCT00253968 (GEMS) is a Phase 3 clinical trial of Eplivanserin in Sleep Initiation and Maintenance Disorders, sponsored by Sanofi.

Who is sponsoring NCT00253968?

NCT00253968 is sponsored by Sanofi.

What drugs are being tested in NCT00253968?

Interventions in NCT00253968: Eplivanserin, placebo.

What condition does NCT00253968 study?

NCT00253968 studies Sleep Initiation and Maintenance Disorders, Insomnia.

Is NCT00253968 still recruiting?

NCT00253968 is currently completed. Last updated 2 February 2016.

Last reviewed 2016-02-02 · How we verify

NCT00253968: GEMS

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 on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study

Completed Phase 3 Last updated 2 February 2016

What this trial tests

Phase 3 trial testing Eplivanserin in Sleep Initiation and Maintenance Disorders in 967 participants. Completed in 1 January 2008.

Timeline

1 November 2005

Primary endpoint
1 January 2008

1 January 2008

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	967
Start date	1 November 2005
Primary completion	1 January 2008
Estimated completion	1 January 2008
Sites	12 locations across United States, Argentina, Australia, Canada, Chile, Czechia, France, Germany

Drugs / interventions tested

Eplivanserin — full drug profile →
placebo

Conditions studied

Sleep Initiation and Maintenance Disorders — all drugs for Sleep Initiation and Maintenance Disorders →
Insomnia — all drugs for Insomnia →

Sponsor

Sanofi — full company profile →

Who can join

18 and older, any sex, with Sleep Initiation and Maintenance Disorders or 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 the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire)
Time frame: at week 12

Sponsor's own description

The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

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 Sleep Initiation and Maintenance Disorders

Currently open trials in the same condition.

NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
NCT05000528 — Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia · NA · recruiting
NCT03642028 — Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress · Phase 4 · recruiting
NCT04598672 — Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease · NA · active not 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 NCT00253968 (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: 2 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/NCT00253968.

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