Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
NCT ID: NCT02839200
Last Updated: 2020-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
360 participants
INTERVENTIONAL
2016-10-04
2017-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ACT-541468 5 mg
Each subject receives one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg
Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1
Placebo capsules matching ACT-541468 capsules
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 10 mg
Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1
Placebo capsules matching ACT-541468 capsules
ACT-541468 25 mg
Each subject receives one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg
Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1
Placebo capsules matching ACT-541468 capsules
ACT-541468 50 mg
Each subject receives two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg
Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Zolpidem
Each subject receives one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem
Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2
Placebo capsules matching over-encapsulated zolpidem
Placebo
Each subject receives two placebo capsules, once daily in the evening for 4 weeks
Placebo 1
Placebo capsules matching ACT-541468 capsules
Interventions
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ACT-541468 5 mg
Capsule for oral administration containing ACT-541468 at a strength of 5 mg
ACT-541468 10 mg
Capsule for oral administration containing ACT-541468 at a strength of 10 mg
ACT-541468 25 mg
Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Zolpidem
Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 1
Placebo capsules matching ACT-541468 capsules
Placebo 2
Placebo capsules matching over-encapsulated zolpidem
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
64 Years
ALL
No
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals Ltd.
Locations
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Investigator Site
Santa Monica, California, United States
Investigator Site
Upland, California, United States
Investigator Site
Brandon, Florida, United States
Investigator Site
Clearwater, Florida, United States
Investigator Site
Coral Gables, Florida, United States
Investigator Site
DeLand, Florida, United States
Investigator Site
Hollywood, Florida, United States
Investigator Site
Miami, Florida, United States
Investigator Site
Atlanta, Georgia, United States
Investigator Site
Chicago, Illinois, United States
Investigator Site
Indianapolis, Indiana, United States
Investigator Site
Novi, Michigan, United States
Investigator Site
Las Vegas, Nevada, United States
Investigator Site
New York, New York, United States
Investigator Site
Cincinnati, Ohio, United States
Investigator Site
Berlin, , Germany
Investigator Site
Berlin, , Germany
Investigator Site
Berlin, , Germany
Investigator Site
Dresden, , Germany
Investigator Site
Hamburg, , Germany
Investigator Site
Hamburg, , Germany
Investigator Site
Hanover, , Germany
Investigator Site
Schwerin, , Germany
Investigator Site
Schwerin, , Germany
Investigator Site
Budapest, , Hungary
Investigator Site
Szeged, , Hungary
Investigator Site
Törökbálint, , Hungary
Investigator Site
Beersheba, , Israel
Investigator Site
Haifa, , Israel
Investigator Site
Barcelona, , Spain
Investigator Site
Barcelona, , Spain
Investigator Site
Madrid, , Spain
Investigator Site
Zaragoza, , Spain
Investigator Site
Gothenburg, , Sweden
Investigator Site
Örebro, , Sweden
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AC-078A201
Identifier Type: -
Identifier Source: org_study_id
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