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

Primary Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00420810
• Other study ID #: 0928-049
• Secondary ID: 2006_514
• Status: Terminated
• Phase: Phase 3
• First received: January 5, 2007
• Last updated: January 13, 2015
• Start date: September 2006

Study information

• Verified date: January 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 138
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• MK0928 / Duration of Treatment : 8 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wake after sleep onset and Latency to persistent sleep
Secondary	Subjective total sleep time and subjective time to sleep onset