An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)

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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00102154
• Other study ID #: 0928-007
• Secondary ID: 2004_093
• Status: Withdrawn
• Phase: Phase 3
• First received: January 21, 2005
• Last updated: January 13, 2015
• Start date: January 2005

Study information

• Verified date: August 2014
• 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 an investigational drug for insomnia (a sleep disorder).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• 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:
• MK0928, gaboxadol / Duration of Treatment: 10 months

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	4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability
Secondary	Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW)