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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00291187
First received: February 3, 2006
Last updated: October 8, 2014
Last verified: October 2014

February 3, 2006
October 8, 2014
February 2006
August 2006   (final data collection date for primary outcome measure)
Average Improvement of Latency to Persistent Sleep (LPS) [ Time Frame: Night 1 ] [ Designated as safety issue: No ]
The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.
Time to fall asleep
Complete list of historical versions of study NCT00291187 on ClinicalTrials.gov Archive Site
Average Improvement of Wake After Sleep Onset (WASO) [ Time Frame: Night 1 ] [ Designated as safety issue: No ]
The average improvement of wake after sleep onset (time spent awake between onset of sleep and lights on, determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.
Amount of time spent asleep and awake during the night, sleep quality, safety and tolerability
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 (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Insomnia
  • Drug: 20 mg VEC-162
    20 mg VEC-162
  • Drug: 50 mg VEC-162
    50 mg VEC-162
  • Drug: 100 mg VEC-162
    100 mg VEC-162
  • Drug: Placebo
    Placebo
  • Placebo Comparator: Placebo
    Take orally 30 minutes prior to bedtime.
    Intervention: Drug: Placebo
  • Experimental: 20 mg VEC-162
    20 mg taken orally 30 minutes prior to bedtime.
    Intervention: Drug: 20 mg VEC-162
  • Experimental: 50 mg VEC-162
    50 mg taken orally 30 minutes prior to bedtime.
    Intervention: Drug: 50 mg VEC-162
  • Experimental: 100 mg VEC-162
    100 mg taken orally 30 minutes prior to bedtime.
    Intervention: Drug: 100 mg VEC-162
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
411
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
No
Vanda Pharmaceuticals
Vanda Pharmaceuticals
Not Provided
Study Director: Vanda Pharmaceuticals Vanda Pharmaceuticals
Vanda Pharmaceuticals
October 2014

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