Elderly Primary Insomnia Polysomnographic Study (0928-002)(TERMINATED)

Primary Insomnia Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Elderly Patients With Primary Insomnia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00094666
• Other study ID #: 0928-002
• Secondary ID: MK0928-0022004_0
• Status: Terminated
• Phase: Phase 3
• First received: October 21, 2004
• Last updated: January 13, 2015
• Start date: November 2004
• Est. completion date: March 2007

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 the study is to test the safety and effectiveness of an Investigational Drug on insomnia in the elderly.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 465
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Elderly patients with a diagnosis of primary insomnia and in good physical and mental health

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• MK0928, gaboxadol / Duration of Treatment - 6 weeks

• Comparator: placebo / Duration of Treatment - 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

References & Publications (1)

Lankford DA, Corser BC, Zheng YP, Li Z, Snavely DB, Lines CR, Deacon S. Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies. Sleep. 2008 Oct;31(10):1359-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of time spent awake and time to fall asleep at night after two days
Secondary	Amount of time spent awake and time to fall asleep at night after 30 days
Secondary	Amount of deep sleep after two days