NCT00784875 (SLUMBER) is a Phase 2 clinical trial of LY2624803 in Primary Insomnia, sponsored by Eli Lilly and Company.

Who is sponsoring NCT00784875?

NCT00784875 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT00784875?

Interventions in NCT00784875: LY2624803, LY2624803, Placebo, zolpidem.

What condition does NCT00784875 study?

NCT00784875 studies Primary Insomnia, Secondary Insomnia.

Is NCT00784875 still recruiting?

NCT00784875 is currently completed. Last updated 30 January 2012.

Are results published for NCT00784875?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2012-01-30 · How we verify

NCT00784875: SLUMBER

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

A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study of the Safety and Efficacy of LY2624803 in Outpatients With Insomnia

Completed Phase 2 Results posted Last updated 30 January 2012

What this trial tests

Phase 2 trial testing LY2624803 in Primary Insomnia in 643 participants. Completed in 1 February 2010.

Timeline

1 October 2008

Primary endpoint
1 February 2010

1 February 2010

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	643
Start date	1 October 2008
Primary completion	1 February 2010
Estimated completion	1 February 2010
Sites	49 locations across United States

Drugs / interventions tested

LY2624803 — full drug profile →
LY2624803 — full drug profile →
Placebo
zolpidem (zolpidem) — full drug profile →

Conditions studied

Primary Insomnia — all drugs for Primary Insomnia →
Secondary Insomnia — all drugs for Secondary Insomnia →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 85, any sex, with Primary Insomnia or Secondary 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 in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint
Time frame: Baseline, 2 weeks
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covarian

Sponsor's own description

The purpose of this study is to compare an investigational drug (LY2624803) with placebo and with zolpidem in the treatment of outpatients with chronic 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 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 Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

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 NCT00784875 (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 Eli Lilly and Company
Last refreshed: 30 January 2012

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/NCT00784875.

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