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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00291187
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : October 15, 2014
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 3, 2006
First Posted Date  ICMJE February 13, 2006
Results First Submitted Date  ICMJE February 28, 2014
Results First Posted Date  ICMJE October 15, 2014
Last Update Posted Date October 15, 2014
Study Start Date  ICMJE February 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2014)
Average Improvement of Latency to Persistent Sleep (LPS) [ Time Frame: Night 1 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2006)
Time to fall asleep
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2014)
Average Improvement of Wake After Sleep Onset (WASO) [ Time Frame: Night 1 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2006)
Amount of time spent asleep and awake during the night, sleep quality, safety and tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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. doi: 10.1016/S0140-6736(08)61812-7. Epub 2008 Dec 4. Erratum in: Lancet. 2009 Apr 11;373(9671):1252.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2014)
411
Original Enrollment  ICMJE
 (submitted: February 9, 2006)
400
Actual Study Completion Date  ICMJE August 2006
Actual 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00291187
Other Study ID Numbers  ICMJE VP-VEC-162-3101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vanda Pharmaceuticals
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Vanda Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Vanda Pharmaceuticals Vanda Pharmaceuticals
PRS Account Vanda Pharmaceuticals
Verification Date October 2014

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