A Study to Evaluate the Effects of GW679769 on Sleep and Cognitive Function in Subjects With Primary Insomnia

Completed · Phase 2 · Has a placebo group

Conditions studied: Sleep Initiation and Maintenance Disorders

In brief

A study to investigate the effects of GW679769 on sleep and cognition. Potential subjects participate in a clinical screening visit and a two-night PSG recording session in the sleep laboratory. Eligible subjects then participate in three separate two-night PSG sessions in which they are randomized to receive placebo or one of two doses of GW679769 60 minutes prior to bedtime, one treatment for each session in a balanced order. Each treatment session is separated by a two-week drug-free period and occur on the same day of the week. A safety follow-up visit occurs 2 weeks after the last treatment session.

Key facts

Study ID

NCT00650871

Run by

GlaxoSmithKline

People needed

48

Starts

2004-07-30

Expected to finish

2005-08-30

Last updated by the study team

2017-08-08

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Healthy male and female subjects with primary insomnia with normal EG may be eligible for inclusion.

You may not qualify if…

• clinically significant physical or psychiatric illness or abnormal sleep patterns.

Where it is running

• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Durham, North Carolina, United States
• GSK Investigational Site — Winston-Salem, North Carolina, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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