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

Phase 2

Completed

• Conditions: Insomnia Disorder
• Interventions: Drug: ACT-541468 10 mg; Drug: ACT-541468 25 mg; Drug: Placebo 1; Drug: ACT-541468 5 mg; Drug: Zolpidem; Drug: Placebo 2

• Registration Number: NCT02839200
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-20
• Study Start: 2016-10-04
• Primary Completion: 2017-04-12
• Study Completion: 2017-06-20
• Disposition First Submitted: 2018-04-26
• Disposition First Submitted QC: 2018-04-26
• Disposition First Posted: 2018-04-27
• Results First Submitted: 2020-03-06
• Results First Submitted QC: 2020-03-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Results First Posted: 2020-04-02
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT-541468 10 mg	ACT-541468 10 mg	Each subject receives one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 25 mg	ACT-541468 25 mg	Each subject receives one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
Placebo	Placebo 1	Each subject receives two placebo capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg	Placebo 1	Each subject receives one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 5 mg	Placebo 1	Each subject receives one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg	Placebo 1	Each subject receives one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 50 mg	ACT-541468 25 mg	Each subject receives two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
Zolpidem	Placebo 2	Each subject receives one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
ACT-541468 5 mg	ACT-541468 5 mg	Each subject receives one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
Zolpidem	Zolpidem	Each subject receives one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2	Baseline and Days 1&2	WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)

Secondary Outcome Measures

Name	Time	Method
Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2	Baseline and Days 1&2	LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG
Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4	Baseline and Week 4	sWASO is the self-reported time spent awake after sleep onset as reported in the sleep diary.
Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4	Baseline and Week 4	sLSO is the self-reported time to fall asleep, as reported in the sleep diary

Trial Locations

Locations (1)

Investigator Site; 🇸🇪 Örebro, Sweden