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Completed

NCT Number: NCT00992160

Vestipitant 28-day Tolerance Study

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

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Key information

Conditions

Sleep Disorders Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Hamburg, Free and Hanseatic City of Hamburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GW597599

Drug

GW597599 15mg tablet

Placebo

Drug

Placebo to match GW597599 15mg tablet

Primary outcomes

  1. Nocturnal polysomngraphy

    Time frame: 6 weeks after start of treatment

Secondary outcomes

  1. Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index

    Time frame: 4 weeks after start of treatment

  2. 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)

    Time frame: 4 weeks after start of treatment

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 9, 2009
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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