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Trial record 3 of 3 for:    Safety and Efficacy of Tasimelteon

VEC-162 Study in Adult Patients With Primary Insomnia

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ClinicalTrials.gov Identifier: NCT00548340
Recruitment Status : Completed
First Posted : October 23, 2007
Results First Posted : October 15, 2014
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Primary Insomnia Drug: VEC-162 20 mg Drug: Placebo Drug: VEC-162 50 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : June 2008

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548340


Locations
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United States, Alabama
Vanda Investigational Site
Birmingham, Alabama, United States
United States, Arkansas
Vanda Investigational Site
Hot Springs, Arkansas, United States
Vanda Investigational Site
Little Rock, Arkansas, United States
United States, California
Vanda Investigational Site
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
United States, Colorado
Vanda Investigational Site
Colorado Springs, Colorado, United States
United States, Florida
Vanda Investigational Site
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
United States, Georgia
Vanda Investigational Site
Atlanta, Georgia, United States
United States, Illinois
Vanda Investigational Site
Chicago, Illinois, United States
United States, Kansas
Vanda Investigational Site
Overland Park, Kansas, United States
United States, Kentucky
Vanda Investigational Site
Crestview Hills, Kentucky, United States
Vanda Investigational Site
Lexington, Kentucky, United States
Vanda Investigational Site
Louisville, Kentucky, United States
United States, Maryland
Vanda Investigational Site
Chevy Chase, Maryland, United States
United States, Massachusetts
Vanda Investigational Site
Newton, Massachusetts, United States
United States, Michigan
Vanda Investigational Site
Troy, Michigan, United States
United States, Missouri
Vanda Investigational Site
Chesterfield, Missouri, United States
United States, Nevada
Vanda Investigational Site
Las Vegas, Nevada, United States
United States, New York
Vanda Investigational Site
New York, New York, United States
Vanda Investigational Site
West Seneca, New York, United States
United States, North Carolina
Vanda Investigational Site
Raleigh, North Carolina, United States
United States, Ohio
Vanda Investigational Site
Beachwood, Ohio, United States
Vanda Investigational Site
Cincinnati, Ohio, United States
United States, Oklahoma
Vanda Investigational Site
Oklahoma City, Oklahoma, United States
United States, South Carolina
Vanda Investigational Site
Columbia, South Carolina, United States
United States, Texas
Vanda Investigational Site
Austin, Texas, United States
Vanda Investigational Site
Dallas, Texas, United States
Sponsors and Collaborators
Vanda Pharmaceuticals
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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00548340    
Other Study ID Numbers: VP-VEC-162-3104
First Posted: October 23, 2007    Key Record Dates
Results First Posted: October 15, 2014
Last Update Posted: October 15, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders