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

Tracking Information
First Received Date ^ICMJE	February 3, 2006
Last Updated Date	February 26, 2008
Start Date ^ICMJE	February 2006
Primary Completion Date	August 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 9, 2006)	Time to fall asleep
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00291187 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 9, 2006)	Amount of time spent asleep and awake during the night, sleep quality, safety and tolerability
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Insomnia
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	400
Completion Date	August 2006
Primary Completion Date	August 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	21 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	NCT00291187
Responsible Party
Study ID Numbers ^ICMJE	VP-VEC-162-3101
Study Sponsor ^ICMJE	Vanda Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
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