Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers

This study has been completed.

First Received: June 22, 2007 Last Updated: February 26, 2008 History of Changes

Sponsor:	Vanda Pharmaceuticals
Information provided by:	Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00490945

Purpose

The purpose of this study is to assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters.

Condition	Intervention	Phase
Circadian Rhythm Sleep Disorders	Drug: VEC-162	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Effects of VEC-162 on Circadian Rhythm in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders

U.S. FDA Resources

Further study details as provided by Vanda Pharmaceuticals:

Primary Outcome Measures:

Exposure response to VEC-162 on induction of circadian phase shift and sleep efficiency parameters

Secondary Outcome Measures:

Amount of time spent asleep, number of awake at night, and sleep quality
Safety and tolerability of VEC-162

Enrollment:	45
Study Start Date:	July 2004
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

No medical, psychiatric, or sleep disorders
Ability to provide written informed consent

Exclusion Criteria:

Lifetime history of night shift work
Evidence of any sleep disorder
Psychiatric or neurological disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490945

Locations

United States, Massachusetts
Vanda Investigational Site
Boston, Massachusetts, United States
United States, Michigan
Vanda Investigational Site
Detroit, Michigan, United States

Sponsors and Collaborators

Vanda Pharmaceuticals

Investigators

Study Director:

Marlene Dressman, PhD

Vanda Pharmaceuticals Inc

More Information

No publications provided by Vanda Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	VP-VEC-162-2101
Study First Received:	June 22, 2007
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00490945 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Signs and Symptoms
Sleep Disorders, Circadian Rhythm
Mental Disorders
Nervous System Diseases
Disorders of Environmental Origin

Dyssomnias
Neurologic Manifestations
Sleep Disorders
Occupational Diseases
Chronobiology Disorders

ClinicalTrials.gov processed this record on November 27, 2009