VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia - Full Text View

Sponsor:	Vanda Pharmaceuticals
Information provided by:	Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00291187

Purpose

The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.

Condition	Intervention	Phase
Insomnia	Drug: VEC-162	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 and Matching Placebo in Healthy Male and Female Subjects With Induced Transient Insomnia

Further study details as provided by Vanda Pharmaceuticals:

Primary Outcome Measures:

Time to fall asleep

Secondary Outcome Measures:

Amount of time spent asleep and awake during the night, sleep quality, safety and tolerability

Estimated Enrollment:	400
Study Start Date:	February 2006
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy subjects with no medical, psychiatric or current sleep disorders.
Subject must sign a written consent form.

Exclusion Criteria:

Recent history of night shift work or jet lag.
Prior experience sleeping in a sleep lab environment.
History of sleep disorders.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291187

Locations

United States, Alabama
Vanda Investigational Site
Birmingham, Alabama, United States
United States, Arizona
Vanda Investigational Site
Phoenix, Arizona, United States
United States, California
Vanda Investigational Site
San Diego, California, United States
Vanda Investigational Site
San Francisco, California, United States
Vanda Investigational Site
Santa Monica, California, United States
United States, Florida
Vanda Investigational Site
Miami, Florida, United States
Vanda Investigational Site
Naples, Florida, United States
Vanda Investigational Site
Pembroke Pines, Florida, United States
Vanda Investigational Site
St. Petersburg, Florida, United States
United States, Georgia
Vanda Investigational Site
Atlanta, Georgia, United States
United States, Kansas
Vanda Investigational Site
Overland Park, Kansas, United States
United States, Maryland
Vanda Investigational Site
Chevy Chase, Maryland, United States
United States, New York
Vanda Investigational Site
New York, New York, United States
Vanda Investigational Site
Rochester, New York, United States
United States, North Carolina
Vanda Investigational Site
Raleigh, North Carolina, United States
United States, Ohio
Vanda Investigational Site
Cincinnati, Ohio, United States
United States, South Carolina
Vanda Investigational Site
Columbia, South Carolina, United States
United States, Texas
Vanda Investigational Site
Austin, Texas, United States
Vanda Investigational Site
Plano, Texas, United States

Sponsors and Collaborators

Vanda Pharmaceuticals

More Information

No publications provided by Vanda Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rajaratnam SM, Polymeropoulos MH, Fisher DM, Roth T, Scott C, Birznieks G, Klerman EB. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. Lancet. 2009 Feb 7;373(9662):482-91. Epub 2008 Dec 4.

ClinicalTrials.gov Identifier:	NCT00291187 History of Changes
Other Study ID Numbers:	VP-VEC-162-3101
Study First Received:	February 3, 2006
Last Updated:	February 26, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias

Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012