Vestipitant 28-day Tolerance Study

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00992160

Enrollment

161

Registered

2009-10-09

Start date

2009-05-31

Completion date

2009-09-30

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorders

Keywords

Polysomnography (PSG), Adults, Primary Insomnia

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.

Interventions

DRUGGW597599

GW597599 15mg tablet

DRUGPlacebo

Placebo to match GW597599 15mg tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Nocturnal polysomngraphy	6 weeks after start of treatment

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026