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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00291187
First received: February 3, 2006
Last updated: October 8, 2014
Last verified: October 2014
  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: 20 mg VEC-162
Drug: 50 mg VEC-162
Drug: 100 mg VEC-162
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Vanda Pharmaceuticals:

Primary Outcome Measures:
  • Average Improvement of Latency to Persistent Sleep (LPS) [ Time Frame: Night 1 ] [ Designated as safety issue: No ]
    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:
  • Average Improvement of Wake After Sleep Onset (WASO) [ Time Frame: Night 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 411
Study Start Date: February 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: Vanda Pharmaceuticals Vanda Pharmaceuticals
  More Information

No publications provided by Vanda Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00291187     History of Changes
Other Study ID Numbers: VP-VEC-162-3101
Study First Received: February 3, 2006
Results First Received: February 28, 2014
Last Updated: October 8, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014