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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insomnia Drug: 20 mg VEC-162 Drug: 50 mg VEC-162 Drug: 100 mg VEC-162 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 411 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Take orally 30 minutes prior to bedtime.
 Drug: Placebo
Placebo
Experimental: 20 mg VEC-162
20 mg taken orally 30 minutes prior to bedtime.
 Drug: 20 mg VEC-162
20 mg VEC-162
Experimental: 50 mg VEC-162
50 mg taken orally 30 minutes prior to bedtime.
 Drug: 50 mg VEC-162
50 mg VEC-162
Experimental: 100 mg VEC-162
100 mg taken orally 30 minutes prior to bedtime.
 Drug: 100 mg VEC-162
100 mg VEC-162


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291187


Locations
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United States, Alabama
Vanda Investigational Site
Birmingham, Alabama, United States
United States, Arizona
Vanda Investigational Site
Phoenix, Arizona, United States
United States, California
Vanda Investigational Site
San Diego, California, United States
Vanda Investigational Site
San Francisco, California, United States
Vanda Investigational Site
Santa Monica, California, United States
United States, Florida
Vanda Investigational Site
Miami, Florida, United States
Vanda Investigational Site
Naples, Florida, United States
Vanda Investigational Site
Pembroke Pines, Florida, United States
Vanda Investigational Site
St. Petersburg, Florida, United States
United States, Georgia
Vanda Investigational Site
Atlanta, Georgia, United States
United States, Kansas
Vanda Investigational Site
Overland Park, Kansas, United States
United States, Maryland
Vanda Investigational Site
Chevy Chase, Maryland, United States
United States, New York
Vanda Investigational Site
New York, New York, United States
Vanda Investigational Site
Rochester, New York, United States
United States, North Carolina
Vanda Investigational Site
Raleigh, North Carolina, United States
United States, Ohio
Vanda Investigational Site
Cincinnati, Ohio, United States
United States, South Carolina
Vanda Investigational Site
Columbia, South Carolina, United States
United States, Texas
Vanda Investigational Site
Austin, Texas, United States
Vanda Investigational Site
Plano, Texas, United States
Sponsors and Collaborators
Vanda Pharmaceuticals
Investigators
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Study Director: Vanda Pharmaceuticals Vanda Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00291187    
Other Study ID Numbers: VP-VEC-162-3101
First Posted: February 13, 2006    Key Record Dates
Results First Posted: October 15, 2014
Last Update Posted: October 15, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders