Vestipitant 28-day Tolerance Study

Phase 2

Completed

• Conditions: Sleep Disorders
• Interventions: Drug: GW597599; Drug: Placebo

• Registration Number: NCT00992160
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-07-16
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	GW597599	Vestipitant 15mg once daily
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Nocturnal polysomngraphy	6 weeks after start of treatment

Secondary Outcome Measures

Name	Time	Method
Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index	4 weeks after start of treatment
Motor and cognitive functioning assessed by neurological tests (Romberg and Hee-to-toe) and Cognitive tests (Digit Symbol Substitution test and verbal Learning Memory test)	4 weeks after start of treatment

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Hamburg, Germany