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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291187
• Other study ID #: VP-VEC-162-3101
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2006
• Last updated: October 8, 2014
• Start date: February 2006
• Est. completion date: August 2006

Study information

• Verified date: October 2014
• Source: Vanda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• 20 mg VEC-162
20 mg VEC-162
• 50 mg VEC-162
50 mg VEC-162
• 100 mg VEC-162
100 mg VEC-162
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Vanda Investigational Site	Atlanta	Georgia
United States	Vanda Investigational Site	Austin	Texas
United States	Vanda Investigational Site	Birmingham	Alabama
United States	Vanda Investigational Site	Chevy Chase	Maryland
United States	Vanda Investigational Site	Cincinnati	Ohio
United States	Vanda Investigational Site	Columbia	South Carolina
United States	Vanda Investigational Site	Miami	Florida
United States	Vanda Investigational Site	Naples	Florida
United States	Vanda Investigational Site	New York	New York
United States	Vanda Investigational Site	Overland Park	Kansas
United States	Vanda Investigational Site	Pembroke Pines	Florida
United States	Vanda Investigational Site	Phoenix	Arizona
United States	Vanda Investigational Site	Plano	Texas
United States	Vanda Investigational Site	Raleigh	North Carolina
United States	Vanda Investigational Site	Rochester	New York
United States	Vanda Investigational Site	San Diego	California
United States	Vanda Investigational Site	San Francisco	California
United States	Vanda Investigational Site	Santa Monica	California
United States	Vanda Investigational Site	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Improvement of Latency to Persistent Sleep (LPS)	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.	Night 1	No
Secondary	Average Improvement of Wake After Sleep Onset (WASO)	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.	Night 1	No