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

NCT02839200 | Completed Phase 2 Results DMC

• 1 other identifier: AC-078A201
• Study Type: interventional
• Target: 360
• Locations: 6 countries
• Sites: 35

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.

Conditions

Insomnia Disorder

Keywords

Insomnia; Polysomnography

Outcome Measures

Primary Outcomes (1)

• Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2

  WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)

  Baseline and Days 1&2

Secondary Outcomes (3)

• Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2

  Baseline and Days 1&2

• Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4

  Baseline and Week 4

• Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4

  Baseline and Week 4

Study Arms (6)

ACT-541468 5 mg

EXPERIMENTAL

Each subject receives one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks

Drug: ACT-541468 5 mg; Drug: Placebo 1

ACT-541468 10 mg

EXPERIMENTAL

Each subject receives one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks

Drug: ACT-541468 10 mg; Drug: Placebo 1

ACT-541468 25 mg

EXPERIMENTAL

Each subject receives one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks

Drug: ACT-541468 25 mg; Drug: Placebo 1

ACT-541468 50 mg

EXPERIMENTAL

Each subject receives two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks

Drug: ACT-541468 25 mg

Zolpidem

ACTIVE COMPARATOR

Each subject receives one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks

Drug: Zolpidem; Drug: Placebo 2

Placebo

PLACEBO COMPARATOR

Each subject receives two placebo capsules, once daily in the evening for 4 weeks

Drug: Placebo 1

Interventions

ACT-541468 5 mg DRUG

Capsule for oral administration containing ACT-541468 at a strength of 5 mg

ACT-541468 5 mg

ACT-541468 10 mg DRUG

Capsule for oral administration containing ACT-541468 at a strength of 10 mg

ACT-541468 10 mg

ACT-541468 25 mg DRUG

Capsule for oral administration containing ACT-541468 at a strength of 25 mg

ACT-541468 25 mg; ACT-541468 50 mg

Zolpidem DRUG

Over-encapsulated zolpidem tablet at a strength of 10 mg

Zolpidem

Placebo 1 DRUG

Placebo capsules matching ACT-541468 capsules

ACT-541468 10 mg; ACT-541468 25 mg; ACT-541468 5 mg; Placebo

Placebo 2 DRUG

Placebo capsules matching over-encapsulated zolpidem

Zolpidem

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent prior to any study-mandated procedure.
• Male or female aged 18-64 years (inclusive).
• Women of childbearing potential must have negative pregnancy tests and use reliable methods of contraception up to 30 days after EOT.
• Body mass index (BMI): 18.5 ≤ BMI (kg/m2) \< 32.0.
• Insomnia disorder according to DSM-5 criteria.
• Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography.
• Insomnia Severity Index score ≥ 15.

You may not qualify if:

• Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.
• Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week.
• Caffeine consumption ≥ 600 mg per day.
• Shift work within 2 weeks prior to the screening visit, or planned shift work during study.
• Travel ≥ 3 time zones within 1 week prior to the screening visit, or planned travel \> or= 3 time zones during study.
• Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator.
• AST and/or ALT \> 2 × ULN and/or direct bilirubin \> 1.5 × ULN (except known history of Gilbert's syndrome).
• Severe renal impairment (known or defined as estimated creatinine clearance \< 30 mL/min).
• History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
• Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (35)

Investigator Site

Santa Monica, California, 90404, United States

Location

Investigator Site

Upland, California, 91786, United States

Location

Investigator Site

Brandon, Florida, 33511, United States

Location

Investigator Site

Clearwater, Florida, 33765, United States

Location

Investigator Site

Coral Gables, Florida, 33134, United States

Location

Investigator Site

DeLand, Florida, 32720, United States

Location

Investigator Site

Hollywood, Florida, 33024, United States

Location

Investigator Site

Miami, Florida, 33143, United States

Location

Investigator Site

Atlanta, Georgia, 30342, United States

Location

Investigator Site

Chicago, Illinois, 60634, United States

Location

Investigator Site

Indianapolis, Indiana, 46250, United States

Location

Investigator Site

Novi, Michigan, 48377, United States

Location

Investigator Site

Las Vegas, Nevada, 89104, United States

Location

Investigator Site

New York, New York, 10019, United States

Location

Investigator Site

Cincinnati, Ohio, 45255, United States

Location

Investigator Site

Berlin, 10115, Germany

Location

Investigator Site

Berlin, 10117, Germany

Location

Investigator Site

Berlin, 12203, Germany

Location

Investigator Site

Dresden, 01069, Germany

Location

Investigator Site

Hamburg, 20251, Germany

Location

Investigator Site

Hamburg, 20253, Germany

Location

Investigator Site

Hanover, 30159, Germany

Location

Investigator Site

Schwerin, 19053, Germany

Location

Investigator Site

Schwerin, 19055, Germany

Location

Investigator Site

Budapest, 1134, Hungary

Location

Investigator Site

Szeged, 6725, Hungary

Location

Investigator Site

Törökbálint, 2045, Hungary

Location

Investigator Site

Beersheba, 84101, Israel

Location

Investigator Site

Haifa, 31096, Israel

Location

Investigator Site

Barcelona, 08017, Spain

Location

Investigator Site

Barcelona, 08035, Spain

Location

Investigator Site

Madrid, 28036, Spain

Location

Investigator Site

Zaragoza, 50015, Spain

Location

Investigator Site

Gothenburg, 413 90, Sweden

Location

Investigator Site

Örebro, 701 85, Sweden

Location

Related Publications (3)

• Dutta S, Singhal S, Shah R, Charan J, Dhingra S, Haque M. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf. 2023 Jul-Dec;22(12):1237-1251. doi: 10.1080/14740338.2023.2243217. Epub 2023 Aug 7.

  PMID: 37526060 DERIVED

• Di Marco T, Scammell TE, Meinel M, Seboek Kinter D, Datta AN, Zammit G, Dauvilliers Y. Number, Duration, and Distribution of Wake Bouts in Patients with Insomnia Disorder: Effect of Daridorexant and Zolpidem. CNS Drugs. 2023 Jul;37(7):639-653. doi: 10.1007/s40263-023-01020-9. Epub 2023 Jul 21.

  PMID: 37477771 DERIVED

• Dauvilliers Y, Zammit G, Fietze I, Mayleben D, Seboek Kinter D, Pain S, Hedner J. Daridorexant, a New Dual Orexin Receptor Antagonist to Treat Insomnia Disorder. Ann Neurol. 2020 Mar;87(3):347-356. doi: 10.1002/ana.25680. Epub 2020 Feb 5.

  PMID: 31953863 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

daridorexant; Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trial Disclosure Desk
• Organization: Idorsia Pharmaceuticals

clinical-trials-disclosure@idorsia.com

+41 588 441977

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 20, 2016
• Study Start: October 4, 2016
• Primary Completion: April 12, 2017
• Study Completion: June 20, 2017
• Last Updated: April 13, 2020
• Results First Posted: April 2, 2020

Record last verified: 2020-04

Locations

ES (4); HU (3); US (15); SE (2); DE (9); IL (2)