Skip to main content
OpenTrials
Completed

NCT Number: NCT00291187

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanda Investigational Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

20 mg VEC-162

Drug

20 mg VEC-162

50 mg VEC-162

Drug

50 mg VEC-162

100 mg VEC-162

Drug

100 mg VEC-162

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Feb 13, 2006
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.