Vestipitant 28-day Tolerance Study

NCT00992160 | Completed Phase 2

• 1 other identifier: 111364
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 13

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.

Conditions

Sleep Disorders

Keywords

Polysomnography (PSG); Adults; Primary Insomnia

Outcome Measures

Primary Outcomes (1)

• Nocturnal polysomngraphy

  6 weeks after start of treatment

Secondary Outcomes (2)

• 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

Study Arms (2)

Active

EXPERIMENTAL

Vestipitant 15mg once daily

Drug: GW597599

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

GW597599 DRUG

GW597599 15mg tablet

Active

Placebo DRUG

Placebo to match GW597599 15mg tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Hamburg, Hamburg, 20246, Germany

Location

GSK Investigational Site

Hamburg, Hamburg, 20253, Germany

Location

GSK Investigational Site

Kassel, Hesse, 34131, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30159, Germany

Location

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19053, Germany

Location

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, Germany

Location

GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10115, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10629, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10787, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 13125, Germany

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Interventions

vestipitant

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: October 9, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (13)