Clinical trial NCT00291187: VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 and Matching Placebo in Healthy Male and Female Subjects With Induced Transient Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-02-13
Enrollment: 411
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects with no medical, psychiatric or current sleep disorders.
* Subject must sign a written consent form.

Exclusion Criteria:

* Recent history of night shift work or jet lag.
* Prior experience sleeping in a sleep lab environment.
* History of sleep disorders.

Primary outcomes:
measure: Average Improvement of Latency to Persistent Sleep (LPS)
timeFrame: Night 1
Secondary outcomes:
measure: Average Improvement of Wake After Sleep Onset (WASO)
timeFrame: Night 1
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Vanda Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Vanda Investigational Site
state: Arizona
city: San Diego
country: United States
facility: Vanda Investigational Site
state: California
city: San Francisco
country: United States
facility: Vanda Investigational Site
state: California
city: Santa Monica
country: United States
facility: Vanda Investigational Site
state: California
city: Miami
country: United States
facility: Vanda Investigational Site
state: Florida
city: Naples
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: Overland Park
country: United States
facility: Vanda Investigational Site
state: Kansas
city: Chevy Chase
country: United States
facility: Vanda Investigational Site
state: Maryland
city: New York
country: United States
facility: Vanda Investigational Site
state: New York
city: Rochester
country: United States
facility: Vanda Investigational Site
state: New York
city: Raleigh
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Columbia
country: United States
facility: Vanda Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Vanda Investigational Site
state: Texas
city: Plano
country: United States
facility: Vanda Investigational Site
state: Texas
Study officials:
affiliation: Vanda Pharmaceuticals
name: Vanda Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Rajaratnam SM, Polymeropoulos MH, Fisher DM, Roth T, Scott C, Birznieks G, Klerman EB. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. Lancet. 2009 Feb 7;373(9662):482-91. doi: 10.1016/S0140-6736(08)61812-7. Epub 2008 Dec 4.