Who is sponsoring NCT00380003?

NCT00380003 is sponsored by Evotec Neurosciences GmbH.

What drugs are being tested in NCT00380003?

Interventions in NCT00380003: EVT 201.

What condition does NCT00380003 study?

NCT00380003 studies Sleep Initiation and Maintenance Disorders.

Is NCT00380003 still recruiting?

NCT00380003 is currently completed. Last updated 29 January 2008.

Last reviewed 2008-01-29 · How we verify

NCT00380003

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

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Crossover Study to Assess the Efficacy of Two Doses of EVT 201 in the Treatment of Primary Insomnia in Adult Patients

Completed Phase 2 Last updated 29 January 2008

What this trial tests

Phase 2 trial testing EVT 201 in Sleep Initiation and Maintenance Disorders in 66 participants. Completed in 1 April 2007.

Timeline

1 September 2006

1 April 2007

Quick facts

Lead sponsor	Evotec Neurosciences GmbH
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	66
Start date	1 September 2006
Estimated completion	1 April 2007
Sites	5 locations across United States

Drugs / interventions tested

EVT 201 — full drug profile →

Conditions studied

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

Sponsor

Evotec Neurosciences GmbH — full company profile →

Who can join

Adults 21 to 64, any sex, with Sleep Initiation and Maintenance Disorders. 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.

Total Sleep Time
Wake after sleep onset

Sponsor's own description

The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating people diagnosed with primary insomnia ( difficulty sleeping with no other significant contributing factor, such as depression).

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

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 NCT00380003 (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 Evotec Neurosciences GmbH
Last refreshed: 29 January 2008

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/NCT00380003.

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