search
Back to results

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

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
20 mg VEC-162
50 mg VEC-162
100 mg VEC-162
Placebo
Sponsored by
Vanda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site
  • Vanda Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

20 mg VEC-162

50 mg VEC-162

100 mg VEC-162

Arm Description

Take orally 30 minutes prior to bedtime.

20 mg taken orally 30 minutes prior to bedtime.

50 mg taken orally 30 minutes prior to bedtime.

100 mg taken orally 30 minutes prior to bedtime.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 3, 2006
Last Updated
October 8, 2014
Sponsor
Vanda Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00291187
Brief Title
VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
411 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Take orally 30 minutes prior to bedtime.
Arm Title
20 mg VEC-162
Arm Type
Experimental
Arm Description
20 mg taken orally 30 minutes prior to bedtime.
Arm Title
50 mg VEC-162
Arm Type
Experimental
Arm Description
50 mg taken orally 30 minutes prior to bedtime.
Arm Title
100 mg VEC-162
Arm Type
Experimental
Arm Description
100 mg taken orally 30 minutes prior to bedtime.
Intervention Type
Drug
Intervention Name(s)
20 mg VEC-162
Intervention Description
20 mg VEC-162
Intervention Type
Drug
Intervention Name(s)
50 mg VEC-162
Intervention Description
50 mg VEC-162
Intervention Type
Drug
Intervention Name(s)
100 mg VEC-162
Intervention Description
100 mg VEC-162
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Average Improvement of Latency to Persistent Sleep (LPS)
Description
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.
Time Frame
Night 1
Secondary Outcome Measure Information:
Title
Average Improvement of Wake After Sleep Onset (WASO)
Description
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.
Time Frame
Night 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Organizational Affiliation
Vanda Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Vanda Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Vanda Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Vanda Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Vanda Investigational Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Vanda Investigational Site
City
Santa Monica
State/Province
California
Country
United States
Facility Name
Vanda Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Vanda Investigational Site
City
Naples
State/Province
Florida
Country
United States
Facility Name
Vanda Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Vanda Investigational Site
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
Vanda Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Vanda Investigational Site
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Vanda Investigational Site
City
Chevy Chase
State/Province
Maryland
Country
United States
Facility Name
Vanda Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Vanda Investigational Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Vanda Investigational Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Vanda Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Vanda Investigational Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Vanda Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Vanda Investigational Site
City
Plano
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19054552
Citation
Rajaratnam SM, Polymeropoulos MH, Fisher DM, Roth T, Scott C, Birznieks G, Klerman EB. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. Lancet. 2009 Feb 7;373(9662):482-91. doi: 10.1016/S0140-6736(08)61812-7. Epub 2008 Dec 4. Erratum In: Lancet. 2009 Apr 11;373(9671):1252.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs