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

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: NCT00490945
Recruitment Status : Completed
First Posted : June 25, 2007
Results First Posted : August 26, 2014
Last Update Posted : August 26, 2014
Sponsor:
Information provided by:
Vanda Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 22, 2007
First Posted Date  ICMJE June 25, 2007
Results First Submitted Date  ICMJE February 28, 2014
Results First Posted Date  ICMJE August 26, 2014
Last Update Posted Date August 26, 2014
Study Start Date  ICMJE July 2004
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2014)
  • Circadian Phase Shift [ Time Frame: Night 3 and Night 4 ]
    Exposure response to VEC-162 on induction of circadian phase shift as measured by Dim Light Melatonin Onset (DLMO) was defined as the time change between Night 3 and Night 4 when melatonin production reached 25% of the maximum melatonin concentration. Samples below LOQ of the melatonin assay were assigned 5 pg/ml.
  • Mean Sleep Efficiency [ Time Frame: Night 4 and Night 2 ]
    Exposure response was measured by comparing the change in sleep efficiencies of VEC-162 and placebo treated subjects upon a sleep schedule phase advance. Sleep efficiency (total time asleep divided by the time allowed as an opportunity for sleep in a period multiplied by 100%, where time allowed for sleep was 8 hours or 480 minutes) was measured objectively by overnight polysomnographic recordings. Sleep efficiency was also compared in parts of the night by dividing the full night into thirds.
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2007)
Exposure response to VEC-162 on induction of circadian phase shift and sleep efficiency parameters
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2014)
  • Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS) [ Time Frame: Night 2 and Night 4 ]
    Wake After Sleep Onset is defined as the total time that is scored as awake in a PSG occurring between sleep onset and lights-on prompt. Latency to Persistent Sleep is defined as the number of epochs (one 30-second interval of the sleep episode) from the beginning of the recording (lights-out) to the start of persistent sleep (first 20 consecutive non-wake state) divided by 2.
  • VEC-162 AUC [ Time Frame: Night 4 ]
  • VEC-162 Cmax [ Time Frame: Night 4 ]
  • VEC-162 Tmax [ Time Frame: Night 4 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2007)
  • Amount of time spent asleep, number of awake at night, and sleep quality
  • Safety and tolerability of VEC-162
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Circadian Rhythm Sleep Disorders
Intervention  ICMJE Drug: VEC-162
Study Arms  ICMJE Not Provided
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: June 22, 2007)
45
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2005
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 NCT00490945
Other Study ID Numbers  ICMJE VP-VEC-162-2101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vanda Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marlene Dressman, PhD Vanda Pharmaceuticals Inc
PRS Account Vanda Pharmaceuticals
Verification Date August 2014

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