Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia (0928-006)(COMPLETED)

Insomnia Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102167
• Other study ID #: 0928-006
• Secondary ID: MK0928-0062004_0
• Status: Completed
• Phase: Phase 3
• First received: January 21, 2005
• Last updated: January 13, 2015
• Start date: February 2005
• Est. completion date: December 2005

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

A study to evaluate the safety and effectiveness of Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia for insomnia (a sleep disorder).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 663
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Healthy adults who are between the ages of 18 and 64

Exclusion Criteria:

• Adults who are diagnosed with insomnia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• gaboxadol
Duration of Treatment -1 day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

References & Publications (1)

Walsh JK, Mayleben D, Guico-Pabia C, Vandormael K, Martinez R, Deacon S. Efficacy of the selective extrasynaptic GABA A agonist, gaboxadol, in a model of transient insomnia: a randomized, controlled clinical trial. Sleep Med. 2008 May;9(4):393-402. Epub 2007 Aug 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of time spent awake and time to fall asleep during one night		one night	No
Secondary	Amount of deep sleep during one night.		one night	No
Secondary	Patient-reported sleep quality and awakenings during 1 night.		one night	No