VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
This study has been completed.
Sponsor:
Vanda Pharmaceuticals
Information provided by:
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00291187
First received: February 3, 2006
Last updated: February 26, 2008
Last verified: February 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Insomnia |
Drug: VEC-162 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Further study details as provided by Vanda Pharmaceuticals:
Primary Outcome Measures:
- Time to fall asleep
Secondary Outcome Measures:
- Amount of time spent asleep and awake during the night, sleep quality, safety and tolerability
| Estimated Enrollment: | 400 |
| Study Start Date: | February 2006 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 21 Years to 50 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291187
Locations
| 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
More Information
No publications provided by Vanda Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00291187 History of Changes |
| Other Study ID Numbers: | VP-VEC-162-3101 |
| Study First Received: | February 3, 2006 |
| Last Updated: | February 26, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013