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

This study has been completed.
Sponsor:
Information provided by:
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00291187
First received: February 3, 2006
Last updated: February 3, 2014
Last verified: February 2014

February 3, 2006
February 3, 2014
February 2006
August 2006   (final data collection date for primary outcome measure)
Time to fall asleep
Same as current
Complete list of historical versions of study NCT00291187 on ClinicalTrials.gov Archive Site
Amount of time spent asleep and awake during the night, sleep quality, safety and tolerability
Same as current
Not Provided
Not Provided
 
VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Insomnia
Drug: VEC-162
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
August 2006
August 2006   (final data collection date for primary outcome measure)

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.
Both
21 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00291187
VP-VEC-162-3101
Not Provided
Not Provided
Vanda Pharmaceuticals
Not Provided
Not Provided
Vanda Pharmaceuticals
February 2014

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