Vestipitant 28-day Tolerance Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00992160
First received: July 16, 2009
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Sleep Disorders
Primary Insomnia
Drug: GW597599
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 28-Day, Polysomnographic and Subjective Assessment of Vestipitant (15mg/Day) for the Treatment of Primary Insomnia in Adult Outpatients

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Nocturnal polysomngraphy [ Time Frame: 6 weeks after start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index [ Time Frame: 4 weeks after start of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: May 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Vestipitant 15mg once daily
Drug: GW597599
GW597599 15mg tablet
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo to match GW597599 15mg tablet

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992160

Locations
Germany
GSK Investigational Site
Kassel, Hessen, Germany, 34131
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 10629
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Hamburg, Germany, 20246
GSK Investigational Site
Hamburg, Germany, 20253
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00992160     History of Changes
Other Study ID Numbers: 111364
Study First Received: July 16, 2009
Last Updated: March 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Polysomnography (PSG)
Adults
Primary Insomnia

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders
Parasomnias
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014