Vestipitant 28-day Tolerance Study

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant 15mg/day for treatment of Primary Insomnia in adults outpatients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Vestipitant

Criteria

Inclusion Criteria:

• Male and female aged 18-64 years inclusively with Diagnosis of Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders -Text Revision (DSM-IV-TR) criteria 307.42

• PSG variables collected during 2consecutive PSG screening nights falling as follows:

TST between 240-420 mins inclusive (both nights) - LPS (Latency to Persistent Sleep):

mean not less than 20mins, each night not less than 15 mins - WASO (Wake After Sleep Onset): mean not less than 60mins, each night not less than 45mins

• Women: non child bearing potential or if child bearing potential agree on Contraceptive Methods listed in Protocol

Exclusion Criteria:

• clinically significant Psychiatric and neurological disorders (sleep disorders other than Primary Insomnia, history of alcohol orother substance abuse or dependnce);

• nightshift or rotating shift-work;

• Lifestyle habits in agreement with Protocol requirement: caffeine - alcohol intake and smoke

• healthy according to GSK criteria - laboratory and ECG limits set in the Protocol