VEC-162 Study in Adult Patients With Primary Insomnia

October 8, 2014 updated by: Vanda Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

322

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Vanda Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, United States
        • Vanda Investigational Site
      • Little Rock, Arkansas, United States
        • Vanda Investigational Site
    • California
      • Anaheim, California, United States
        • Vanda Investigational Site
      • Burbank, California, United States
        • Vanda Investigational Site
      • Los Angeles, California, United States
        • Vanda Investigational Site
      • San Diego, California, United States
        • Vanda Investigational Site
      • Santa Monica, California, United States
        • Vanda Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • Vanda Investigational Site
    • Florida
      • Hallandale Beach, Florida, United States
        • Vanda Investigational Site
      • Miami, Florida, United States
        • Vanda Investigational Site
      • Naples, Florida, United States
        • Vanda Investigational Site
      • Orlando, Florida, United States
        • Vanda Investigational Site
      • Pembroke Pines, Florida, United States
        • Vanda Investigational Site
      • St. Petersburg, Florida, United States
        • Vanda Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • Vanda Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • Vanda Investigational Site
    • Kansas
      • Overland Park, Kansas, United States
        • Vanda Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States
        • Vanda Investigational Site
      • Lexington, Kentucky, United States
        • Vanda Investigational Site
      • Louisville, Kentucky, United States
        • Vanda Investigational Site
    • Maryland
      • Chevy Chase, Maryland, United States
        • Vanda Investigational Site
    • Massachusetts
      • Newton, Massachusetts, United States
        • Vanda Investigational Site
    • Michigan
      • Troy, Michigan, United States
        • Vanda Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States
        • Vanda Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Vanda Investigational Site
    • New York
      • New York, New York, United States
        • Vanda Investigational Site
      • West Seneca, New York, United States
        • Vanda Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States
        • Vanda Investigational Site
    • Ohio
      • Beachwood, Ohio, United States
        • Vanda Investigational Site
      • Cincinnati, Ohio, United States
        • Vanda Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Vanda Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States
        • Vanda Investigational Site
    • Texas
      • Austin, Texas, United States
        • Vanda Investigational Site
      • Dallas, Texas, United States
        • Vanda Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VEC-162 20 mg
VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks
Drug: VEC-162 20 mg
20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
Experimental: VEC-162 50 mg
VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks
Drug: VEC-162 50 mg
50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
Placebo Comparator: Placebo
Placebo capsules PO daily five weeks
Drug: Placebo
Placebo capsules, PO daily for five weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Change From Baseline - Latency to Persistent Sleep (LPS)
Time Frame: Baseline, Night 1, and Night 8 measurement
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.
Baseline, Night 1, and Night 8 measurement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)
Time Frame: Baseline, Night 1, and Night 8 measurements for WASO and 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.
Baseline, Night 1, and Night 8 measurements for WASO and TST

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

October 19, 2007

First Submitted That Met QC Criteria

October 19, 2007

First Posted (Estimate)

October 23, 2007

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 8, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VEC-162-3104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Insomnia

Clinical Trials on VEC-162 20 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe