A Double-Blind, Placebo Controlled, Randomized, Cross-Over Polysomnographic Study of MK0928 15 mg in Adult Patients With Primary Insomnia

H. Lundbeck A/S0 sites138 target enrollmentSeptember 2006

ConditionsPrimary Insomnia

DrugsMK0928 / Duration of Treatment : 8 Weeks

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Primary Insomnia
Sponsor: H. Lundbeck A/S
Enrollment: 138
Primary Endpoint: Wake after sleep onset and Latency to persistent sleep
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

March 2007

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

H. Lundbeck A/S

Eligibility 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