VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
October 8, 2014 updated by: Vanda Pharmaceuticals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
411
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
- Vanda Investigational Site
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Arizona
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Phoenix, Arizona, United States
- Vanda Investigational Site
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California
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San Diego, California, United States
- Vanda Investigational Site
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San Francisco, California, United States
- Vanda Investigational Site
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Santa Monica, California, United States
- Vanda Investigational Site
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Florida
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Miami, Florida, United States
- Vanda Investigational Site
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Naples, Florida, United States
- Vanda Investigational Site
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Pembroke Pines, Florida, United States
- Vanda Investigational Site
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St. Petersburg, Florida, United States
- Vanda Investigational Site
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Georgia
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Atlanta, Georgia, United States
- Vanda Investigational Site
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Kansas
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Overland Park, Kansas, United States
- Vanda Investigational Site
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Maryland
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Chevy Chase, Maryland, United States
- Vanda Investigational Site
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New York
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New York, New York, United States
- Vanda Investigational Site
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Rochester, New York, United States
- Vanda Investigational Site
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North Carolina
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Raleigh, North Carolina, United States
- Vanda Investigational Site
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Ohio
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Cincinnati, Ohio, United States
- Vanda Investigational Site
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South Carolina
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Columbia, South Carolina, United States
- Vanda Investigational Site
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Texas
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Austin, Texas, United States
- Vanda Investigational Site
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Plano, Texas, United States
- Vanda Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Placebo
Take orally 30 minutes prior to bedtime.
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Placebo
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Experimental: 20 mg VEC-162
20 mg taken orally 30 minutes prior to bedtime.
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20 mg VEC-162
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Experimental: 50 mg VEC-162
50 mg taken orally 30 minutes prior to bedtime.
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50 mg VEC-162
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Experimental: 100 mg VEC-162
100 mg taken orally 30 minutes prior to bedtime.
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100 mg VEC-162
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Average Improvement of Latency to Persistent Sleep (LPS)
Time Frame: Night 1
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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.
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Night 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Night 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
February 3, 2006
First Submitted That Met QC Criteria
February 9, 2006
First Posted (Estimate)
February 13, 2006
Study Record Updates
Last Update Posted (Estimate)
October 15, 2014
Last Update Submitted That Met QC Criteria
October 8, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VP-VEC-162-3101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.