VEC-162 Study in Adult Patients With Primary Insomnia

Primary Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548340
• Other study ID #: VP-VEC-162-3104
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2007
• Last updated: October 8, 2014
• Start date: November 2007
• Est. completion date: June 2008

Study information

• Verified date: October 2014
• Source: Vanda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: June 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• VEC-162 20 mg
20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
• Placebo
Placebo capsules, PO daily for five weeks
• VEC-162 50 mg
50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Baseline, Night 1, and Night 8 measurements for WASO and TST	Yes