search
Back to results

VEC-162 Study in Adult Patients With Primary Insomnia

Primary Purpose

Primary Insomnia

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

About this trial

This is an interventional treatment trial for Primary Insomnia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females with a diagnosis of primary insomnia as defined in DSM-IV.
  • Habitual bedtime between 9:00 pm and 1:00 am.
  • No history or evidence of restless leg syndrome or periodic limb movement disorder or sleep apnea.
  • Patients must sign a written consent form.

Exclusion Criteria:

  • History of drug or alcohol abuse as defined in DSM-IV.
  • History of psychiatric disorders, including Major Depressive Disorder, Generalized Anxiety Disorder and delirium.
  • History of chronic obstructive pulmonary disease (COPD), seizures, sleep apnea, narcolepsy, circadian-rhythm sleep disorder, parasomnia or any sleep disorder other than chronic insomnia.
  • Recent history of shift work or jet lag.

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
  • 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 Type

Experimental

Experimental

Placebo Comparator

Arm Label

VEC-162 20 mg

VEC-162 50 mg

Placebo

Arm Description

VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks

VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks

Placebo capsules PO daily five weeks

Outcomes

Primary Outcome Measures

Average Change From Baseline - Latency to Persistent Sleep (LPS)
Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8.

Secondary Outcome Measures

Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)
Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 1 and 8. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 1 and 8.

Full Information

First Posted
October 19, 2007
Last Updated
October 8, 2014
Sponsor
Vanda Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00548340
Brief Title
VEC-162 Study in Adult Patients With Primary Insomnia
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 (20 mg/Day and 50 mg/Day) in the Treatment of Primary Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
322 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VEC-162 20 mg
Arm Type
Experimental
Arm Description
VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks
Arm Title
VEC-162 50 mg
Arm Type
Experimental
Arm Description
VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules PO daily five weeks
Intervention Type
Drug
Intervention Name(s)
VEC-162 20 mg
Intervention Description
20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules, PO daily for five weeks
Intervention Type
Drug
Intervention Name(s)
VEC-162 50 mg
Intervention Description
50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
Primary Outcome Measure Information:
Title
Average Change From Baseline - Latency to Persistent Sleep (LPS)
Description
Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8.
Time Frame
Baseline, Night 1, and Night 8 measurement
Secondary Outcome Measure Information:
Title
Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)
Description
Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 1 and 8. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 1 and 8.
Time Frame
Baseline, Night 1, and Night 8 measurements for WASO and TST

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females with a diagnosis of primary insomnia as defined in DSM-IV. Habitual bedtime between 9:00 pm and 1:00 am. No history or evidence of restless leg syndrome or periodic limb movement disorder or sleep apnea. Patients must sign a written consent form. Exclusion Criteria: History of drug or alcohol abuse as defined in DSM-IV. History of psychiatric disorders, including Major Depressive Disorder, Generalized Anxiety Disorder and delirium. History of chronic obstructive pulmonary disease (COPD), seizures, sleep apnea, narcolepsy, circadian-rhythm sleep disorder, parasomnia or any sleep disorder other than chronic insomnia. Recent history of shift work or jet lag.
Facility Information:
Facility Name
Vanda Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Vanda Investigational Site
City
Hot Springs
State/Province
Arkansas
Country
United States
Facility Name
Vanda Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Vanda Investigational Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Vanda Investigational Site
City
Burbank
State/Province
California
Country
United States
Facility Name
Vanda Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Vanda Investigational Site
City
San Diego
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
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Vanda Investigational Site
City
Hallandale Beach
State/Province
Florida
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
Orlando
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
Chicago
State/Province
Illinois
Country
United States
Facility Name
Vanda Investigational Site
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Vanda Investigational Site
City
Crestview Hills
State/Province
Kentucky
Country
United States
Facility Name
Vanda Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Vanda Investigational Site
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Vanda Investigational Site
City
Chevy Chase
State/Province
Maryland
Country
United States
Facility Name
Vanda Investigational Site
City
Newton
State/Province
Massachusetts
Country
United States
Facility Name
Vanda Investigational Site
City
Troy
State/Province
Michigan
Country
United States
Facility Name
Vanda Investigational Site
City
Chesterfield
State/Province
Missouri
Country
United States
Facility Name
Vanda Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Vanda Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Vanda Investigational Site
City
West Seneca
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
Beachwood
State/Province
Ohio
Country
United States
Facility Name
Vanda Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Vanda Investigational Site
City
Oklahoma City
State/Province
Oklahoma
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
Dallas
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

VEC-162 Study in Adult Patients With Primary Insomnia

We'll reach out to this number within 24 hrs