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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Drug: Placebo; Drug: GW679769

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650871

GW679769/903

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.