VEC-162 Study in Adult Patients With Primary Insomnia
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
1 other identifier
interventional
322
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2007
Shorter than P25 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2007
CompletedFirst Posted
Study publicly available on registry
October 23, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
October 15, 2014
CompletedOctober 15, 2014
October 1, 2014
3 months
October 19, 2007
February 28, 2014
October 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Night 1, and Night 8 measurement
Secondary Outcomes (1)
Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)
Baseline, Night 1, and Night 8 measurements for WASO and TST
Study Arms (3)
VEC-162 20 mg
EXPERIMENTALVEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks
VEC-162 50 mg
EXPERIMENTALVEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks
Placebo
PLACEBO COMPARATORPlacebo capsules PO daily five weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Vanda Investigational Site
Birmingham, Alabama, United States
Vanda Investigational Site
Hot Springs, Arkansas, United States
Vanda Investigational Site
Little Rock, Arkansas, United States
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
Vanda Investigational Site
Colorado Springs, Colorado, United States
Vanda Investigational Site
Hallandale, 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
Atlanta, Georgia, United States
Vanda Investigational Site
Chicago, Illinois, United States
Vanda Investigational Site
Overland Park, Kansas, United States
Vanda Investigational Site
Crestview Hills, Kentucky, United States
Vanda Investigational Site
Lexington, Kentucky, United States
Vanda Investigational Site
Louisville, Kentucky, United States
Vanda Investigational Site
Chevy Chase, Maryland, United States
Vanda Investigational Site
Newton, Massachusetts, United States
Vanda Investigational Site
Troy, Michigan, United States
Vanda Investigational Site
Chesterfield, Missouri, United States
Vanda Investigational Site
Las Vegas, Nevada, United States
Vanda Investigational Site
New York, New York, United States
Vanda Investigational Site
West Seneca, New York, United States
Vanda Investigational Site
Raleigh, North Carolina, United States
Vanda Investigational Site
Beachwood, Ohio, United States
Vanda Investigational Site
Cincinnati, Ohio, United States
Vanda Investigational Site
Oklahoma City, Oklahoma, United States
Vanda Investigational Site
Columbia, South Carolina, United States
Vanda Investigational Site
Austin, Texas, United States
Vanda Investigational Site
Dallas, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marlene Dressman, Ph.D.
- Organization
- Vanda Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2007
First Posted
October 23, 2007
Study Start
November 1, 2007
Primary Completion
February 1, 2008
Study Completion
June 1, 2008
Last Updated
October 15, 2014
Results First Posted
October 15, 2014
Record last verified: 2014-10