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

Tracking Information

First Received Date ^ICMJE

June 22, 2007

Last Updated Date

February 26, 2008

Start Date ^ICMJE

July 2004

Primary Completion Date

March 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00490945 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Effects of VEC-162 on Circadian Rhythm in Healthy Subjects

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Circadian Rhythm Sleep Disorders

Intervention ^ICMJE

Drug: VEC-162

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2005

Primary Completion Date

March 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00490945

Responsible Party

Study ID Numbers ^ICMJE

VP-VEC-162-2101

Study Sponsor ^ICMJE

Vanda Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Marlene Dressman, PhD

Vanda Pharmaceuticals Inc

Information Provided By

Vanda Pharmaceuticals

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP