Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

Insomnia Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545191
• Other study ID #: ID-078A301
• Status: Completed
• Phase: Phase 3
• Start date: June 4, 2018
• Est. completion date: February 25, 2020

Study information

• Verified date: March 2022
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 930
• Est. completion date: February 25, 2020
• Est. primary completion date: January 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent prior to any study-mandated procedure;
• Male or female aged = 18 years;
• Insomnia disorder according to DSM-5 criteria;
• Insomnia Severity Index score = 15;
• Insufficient sleep quantity as collected subjectively in the sleep diary;
• Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.

Exclusion Criteria:

• Body mass index below 18.5 or above 40.0 kg/m2;
• Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/ hypopnea;
• Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
• Self-reported usual daytime napping = 1 hour per day and = 3 days per week;
• Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
• Mini Mental State Examination (MMSE) score < 25 in subjects = 50 years;
• For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
• 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.

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Daridorexant 25 mg
Daridorexant will be administered as tablets, orally, once daily in the evening.
• Daridorexant 50 mg
Daridorexant will be administered as tablets, orally, once daily in the evening.

Other:
• Placebo
Matching placebo will be administered as tablets, orally, once daily in the evening.

Locations

Country	Name	City	State
Australia	Respiratory Clinical Trials	Adelaide
Australia	Genesis Sleep Care Queensland	Auchenflower
Australia	Melbourne Sleep Disorders Centre	East Melbourne
Australia	The Woolcock Institute of Medical Research	Glebe
Australia	Royal Melbourne Hospital, Department of Respiratory Medicine	Parkville
Australia	Gold Coast University Hospital, Respiratory Medicine and Sleep Services	Southport
Australia	Westmead Hospital, Department of Respiratory and Sleep Medicine	Westmead
Canada	Tri-Hospital Sleep Laboratory West	Mississauga
Canada	CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)	Quebec
Canada	Jodha Tishon Inc.	Toronto
Canada	MedSleep	Toronto
Denmark	Scan Sleep Specialists	København
Germany	emovis GmbH	Berlin
Germany	St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin	Berlin
Germany	Synexus Berlin Research Centre	Berlin
Germany	Clinical Trial Center North GmbH & Co. KG	Hamburg
Germany	Klinische Forschung Hamburg GmbH	Hamburg
Germany	Klinische Forschung Karlsruhe GmbH	Karlsruhe
Germany	Studienzentrum Wilhelmshöhe GmbH	Kassel
Germany	Synexus Leipzig Research Centre	Leipzig
Germany	Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy	München
Germany	Kinische Forschung Schwerin GmbH	Schwerin
Germany	ZMS Zentrum für medizinische Studien GmbH	Warendorf
Italy	Ospedale San Raffaele - Centro per i Disturbi del Sonno San Raffaele - Ville-Turro - Pallazzina E	Milano
Italy	IRCCS FONDAZIONE Istituto Neurologico Nazionale "Casimiro Mondino" - Centro di Ricerca Interdipartimentale per la SSclerosi Multipla (CRISM) -	Pavia
Italy	Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara - Centro di Medicina del Sonno - Clinica Neuroligica - Dipartimento de Neuroscienze	Pisa
Italy	AOU Citta della Salute e della Scienza - Molinette - SSD Medicina del Sonno	Torino
Poland	PI-House - Centrum Badan Klinicznych	Gdansk
Poland	Osrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)	Warsaw
Poland	EMC Instytut Medyczny SA, Przychodnia przy Lowieckiej	Wroclaw
Serbia	General Hospital Bel Medic, Center for Sleep disorders	Belgrade
Serbia	Medigroup - Health Center Dr Ristic (MediGroup Dom zdravlja "Dr Ristic") - Neurology Department	Novi Beograd
Spain	Centro Médico Teknon - Medicina del Sueño	Barcelona
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit	Barcelona
Spain	Hospital General de Castellon	Castelló de la Plana
Spain	Instituto de Investigaciones del Sueno	Madrid
Spain	San Carlos University Hospital - Servicio de Neurofisiología Clínica	Madrid
Spain	Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño	Vitoria-Gasteiz
Spain	Hospital MAZ - Neurophisiology and Sleep Department	Zaragoza
Switzerland	KSM Bad Zurzach, Klinik für Schlafmedizin	Bad Zurzach
Switzerland	Universitäre Psychiatrische Kliniken Basel (Upk)	Basel
Switzerland	Universitätsklinik für Neurologie, Inselspital Bern, Schlaf-Wach-Epilepsie-Zentrum	Bern
Switzerland	Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald	Wald
Switzerland	Zentrum für Schlafmedizin GZO AG Spital Wetzikon	Wetzikon
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Inquest Clinical Research	Baytown	Texas
United States	Pulmonary Associates of the Southeast/WCR	Birmingham	Alabama
United States	PAB Clinical Research	Brandon	Florida
United States	Helene Emsellem, MD	Chevy Chase	Maryland
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	St. Francis Sleep Allergy and Lung Institute	Clearwater	Florida
United States	Bogan Sleep Consulting, LLC	Columbia	South Carolina
United States	Innovative Clinical Research, Inc.	Hialeah	Florida
United States	Research Centers of America	Hollywood	Florida
United States	Research Carolina of Huntersville	Huntersville	North Carolina
United States	Marvel Clinical Research	Huntington Beach	California
United States	Tri-State Mountain Neurology	Johnson City	Tennessee
United States	Barrett Clinic	La Vista	Nebraska
United States	Canvas Clinical Research, LLC	Lake Worth	Florida
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	BTC of Lincoln	Lincoln	Rhode Island
United States	Preferred Research Partners, Inc	Little Rock	Arkansas
United States	Long Beach Clinical Trials	Long Beach	California
United States	Kentucky Research Group	Louisville	Kentucky
United States	BioMed Research Institute	Miami	Florida
United States	LaPorte County Institute for Clinical Research	Michigan City	Indiana
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Coastal Carolina Healthcare	New Bern	North Carolina
United States	Clinilabs NYC	New York	New York
United States	Infinity Medical Research, Inc.	North Dartmouth	Massachusetts
United States	Aspen Clinical Research	Orem	Utah
United States	Pulmonary Associates of Richmond	Richmond	Virginia
United States	Woodland Research Northwest	Rogers	Arkansas
United States	Oregon Center for Clinical Investigations,Inc	Salem	Oregon
United States	Sleep Therapy & Research Center	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Swedish Medical Center	Seattle	Washington
United States	Sleep Disorders Centers of the Mid-Atlantic	Vienna	Virginia
United States	Omega Medical Research	Warwick	Rhode Island
United States	Clinical Site Partners, LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  Germany,  Italy,  Poland,  Serbia,  Spain,  Switzerland, 

References & Publications (2)

Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H. Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2021 Mar;14(2):249-268. doi: 10.1007/s40271-020-00474-z. Epub 2020 Nov 1. — View Citation

Mignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti CLA, Pain S, Kinter DS, Roth T; investigators. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)	"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.	From baseline to Month 1 (i.e. for up to 1 month)
Primary	Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)	"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.	From baseline to Month 3 (i.e. for up to 3 months)
Primary	Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)	"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.	From baseline to Month 1 (i.e. for up to 1 month)
Primary	Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)	"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.	From baseline to Month 3 (i.e. for up to 3 months)
Secondary	Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)	"Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.	From baseline to Month 1 (i.e. for up to 1 month)
Secondary	Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)	"Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.	From baseline to Month 3 (i.e. for up to 3 months)
Secondary	Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score	The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.	From baseline to Month 1 (i.e. for up to 1 month)
Secondary	Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score	The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.	From baseline to Month 3 (i.e. for up to 3 months)