VEC-162 Study in Adult Patients With Primary Insomnia

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals

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.