VEC-162 Study in Adult Patients With Primary Insomnia

Completed · Phase 3 · Has a placebo group

Conditions studied: Primary Insomnia

In brief

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.

Key facts

Study ID

NCT00548340

Run by

Vanda Pharmaceuticals

People needed

322

Starts

2007-11-01

Expected to finish

2008-06-01

Last updated by the study team

2014-10-15

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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