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

Lundbeck

Status and phase

Terminated

Phase 3

Conditions

Primary Insomnia

Treatments

Drug: MK0928 / Duration of Treatment : 8 Weeks

Study type

Interventional

Funder types

Industry

Identifiers

NCT00420810

0928-049

2006_514

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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