Overview

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

Status:
Completed

Trial end date:
2005-08-30

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

GlaxoSmithKline

Treatments:

Casopitant

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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