Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared against placebo in order to determine if there's a difference.

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

Details

• Lead Sponsor: H. Lundbeck A/S

Criteria

Inclusion Criteria:

• Diagnosis of Primary Insomnia

• Patient is willing to stay overnight at a sleep laboratory for a total of 7 nights

• Patient is willing to avoid alcohol on PSG visits

• Patient will avoid napping during the course of the study

• Patient's bedtime is between 9pm and 1am

Exclusion Criteria:

• History of substance abuse, bipolar disorder or psychotic disorder

• Difficulty sleeping due to other medical condition

• History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome

• History of neoplastic malignancy within the last 5 years

• Positive alcohol breath test during the screening visits