Clinical trial NCT00992160: Vestipitant 28-day Tolerance Study
Official title: A 28-Day, Polysomnographic and Subjective Assessment of Vestipitant (15mg/Day) for the Treatment of Primary Insomnia in Adult Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Disorders
Keywords: Polysomnography (PSG)
Adults
Primary Insomnia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Nocturnal polysomngraphy
timeFrame: 6 weeks after start of treatment
Secondary outcomes:
measure: Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index
timeFrame: 4 weeks after start of treatment
measure: 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)
timeFrame: 4 weeks after start of treatment
Other outcomes:
Locations:
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Schwerin
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Schwerin
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: