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Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder

2016-07-21 02:23:21 | BioPortfolio

Summary

The primary objective of this study is to assess the effect of ACT-541468 on a measure of sleep maintenance (Wake after Sleep Onset or WASO) by polysomnography in subjects with insomnia disorder.

Description

This study consists of the following phases: screening phase; double-blind treatment phase; safety follow-up phase. Safety is monitored throughout the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Insomnia Disorder

Intervention

ACT-541468 5 mg, ACT-541468 10 mg, ACT-541468 25 mg, Zolpidem, Placebo 1, Placebo 2

Location

Investigator Site
Santa Monica
California
United States
90404

Status

Not yet recruiting

Source

Actelion

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-07-21T02:23:21-0400

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Relevant Topic

Sleep Disorders
Sleep disorders disrupt sleep during the night, or cause sleepiness during the day, caused by physiological or psychological factors. The common ones include snoring and sleep apnea, insomnia, parasomnias, sleep paralysis, restless legs syndrome, circa...


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