Vestipitant 28-day Tolerance Study

Sleep Disorders Clinical Trial

Official title:

A 28-Day, Polysomnographic and Subjective Assessment of Vestipitant (15mg/Day) for the Treatment of Primary Insomnia in Adult Outpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992160
• Other study ID #: 111364
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2009
• Last updated: October 26, 2016
• Start date: May 2009
• Est. completion date: September 2009

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Drug:
• GW597599
GW597599 15mg tablet
• Placebo
Placebo to match GW597599 15mg tablet

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Kassel	Hessen
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nocturnal polysomngraphy		6 weeks after start of treatment
Secondary	Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index		4 weeks after start of treatment
Secondary	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

External Links

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