Clinical trial NCT00548340: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Insomnia
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-10-23
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Average Change From Baseline - Latency to Persistent Sleep (LPS)
timeFrame: Baseline, Night 1, and Night 8 measurement
Secondary outcomes:
measure: Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)
timeFrame: Baseline, Night 1, and Night 8 measurements for WASO and TST
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Vanda Investigational Site
state: Alabama
city: Hot Springs
country: United States
facility: Vanda Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Vanda Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Vanda Investigational Site
state: California
city: Burbank
country: United States
facility: Vanda Investigational Site
state: California
city: Los Angeles
country: United States
facility: Vanda Investigational Site
state: California
city: San Diego
country: United States
facility: Vanda Investigational Site
state: California
city: Santa Monica
country: United States
facility: Vanda Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Vanda Investigational Site
state: Colorado
city: Hallandale Beach
country: United States
facility: Vanda Investigational Site
state: Florida
city: Miami
country: United States
facility: Vanda Investigational Site
state: Florida
city: Naples
country: United States
facility: Vanda Investigational Site
state: Florida
city: Orlando
country: United States
facility: Vanda Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Vanda Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Vanda Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Vanda Investigational Site
state: Illinois
city: Overland Park
country: United States
facility: Vanda Investigational Site
state: Kansas
city: Crestview Hills
country: United States
facility: Vanda Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Vanda Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Vanda Investigational Site
state: Kentucky
city: Chevy Chase
country: United States
facility: Vanda Investigational Site
state: Maryland
city: Newton
country: United States
facility: Vanda Investigational Site
state: Massachusetts
city: Troy
country: United States
facility: Vanda Investigational Site
state: Michigan
city: Chesterfield
country: United States
facility: Vanda Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Vanda Investigational Site
state: Nevada
city: New York
country: United States
facility: Vanda Investigational Site
state: New York
city: West Seneca
country: United States
facility: Vanda Investigational Site
state: New York
city: Raleigh
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Vanda Investigational Site
state: Oklahoma
city: Columbia
country: United States
facility: Vanda Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Vanda Investigational Site
state: Texas
city: Dallas
country: United States
facility: Vanda Investigational Site
state: Texas
Study officials:
References: