Vestipitant 28-day Tolerance Study

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Sleep Disorders

Treatments: Drug: Placebo; Drug: GW597599

Study type: Interventional

Funder types: Industry

Identifiers

NCT00992160

111364

Details and patient eligibility

About

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

Enrollment: 161 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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161 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Vestipitant 15mg once daily

Treatment:

Drug: GW597599

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo