NCT02839200

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

Multi-center, Double-blind, Randomized, Placebo-controlled, Active-reference, Parallel-group, Polysomnography Dose-response Study to Assess the Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.

Detailed description

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

Conditions

• Insomnia Disorder

Interventions

Type	Name	Description
DRUG	ACT-541468 5 mg	Capsule for oral administration containing ACT-541468 at a strength of 5 mg
DRUG	ACT-541468 10 mg	Capsule for oral administration containing ACT-541468 at a strength of 10 mg
DRUG	ACT-541468 25 mg	Capsule for oral administration containing ACT-541468 at a strength of 25 mg
DRUG	Zolpidem	Over-encapsulated zolpidem tablet at a strength of 10 mg
DRUG	Placebo 1	Placebo capsules matching ACT-541468 capsules
DRUG	Placebo 2	Placebo capsules matching over-encapsulated zolpidem

Timeline

• Start date: 2016-10-04
• Primary completion: 2017-04-12
• Completion: 2017-06-20
• First posted: 2016-07-20
• Last updated: 2020-04-13
• Results posted: 2020-04-02

Locations

35 sites across 6 countries: United States, Germany, Hungary, Israel, Spain, Sweden