Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

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: NCT03575104
• Other study ID #: ID-078A302
• Status: Completed
• Phase: Phase 3
• Start date: May 29, 2018
• Est. completion date: May 14, 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: 924
• Est. completion date: May 14, 2020
• Est. primary completion date: April 9, 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 and validated objectively by polysomnography;

• 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
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
Belgium	HOSPITAL AZ SINT-JAN_Neurology department	Brugge
Belgium	Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory	Brussels
Belgium	University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring	Gent
Belgium	Hospital UZ Leuven_ Pneumology Department	Leuven
Bulgaria	Acibadem City Clinic Tokuda Hospital EAD	Sofia
Canada	Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1	Etobicoke
Canada	The Medical Arts Health Research Group	Kelowna
Canada	Somni Research Inc.	Markham
Canada	Canadian Phase Onward Inc.	Toronto	Ontario
Canada	CANADIAN PHASE ONWARD INC. (Toronto)	Toronto
Canada	Somni Research, Calgary	Toronto
Czechia	Nemocnice Ceské Budejovice, Centrum pro poruchy spánku a spánkovou medicínu	Ceské Budejovice
Czechia	Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health)	Klecany
Czechia	Fakultní nemocnice Ostrava, Spánková laborator	Ostrava-Poruba
Finland	Vitalmed Uniklinikka	Helsinki
Finland	Oivauni Oy - Kuopio	Kuopio
Finland	Oivauni Oy - Tampere	Tampere
Finland	Unitutkimusyksikkö, Turun Yliopisto	Turku
France	CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique	Lille
France	Clinique beau soleil - Department Sleep and Neurology	Montpellier
France	CHU NIMES - Unité de Sommeil	Nîmes
Germany	Advanced Sleep Research GmbH	Berlin
Germany	Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin	Berlin
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	Synexus Clinical Research GmbH	Bochum
Germany	Klinische Forschung Dresden GmbH	Dresden
Germany	Synexus Clinical Research GmbH	Frankfurt
Germany	Klinische Forschung Hannover Mitte GmbH	Hannover
Germany	Interdisziplinäre Schlafmedizin, Pfalzklinikum	Klingenmünster
Germany	Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck	Lübeck
Germany	Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University	Mannheim
Germany	Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg	Regensburg
Germany	SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH	Schwerin
Hungary	Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály	Budapest
Hungary	Somnius Kft. SomnoCenter Szeged	Szeged
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu	Gwangju
Korea, Republic of	8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu	Seongnam
Korea, Republic of	1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu	Seoul
Korea, Republic of	3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu	Seoul
Korea, Republic of	B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu	Seoul
Korea, Republic of	B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu	Seoul
Korea, Republic of	2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu	Suwon
Sweden	Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar	Göteborg
Sweden	Universitetssjukhuset Örebro Neurokliniken, Sömnenheten	Örebro
Sweden	SOPHIAHEMMET (Stockholm)	Stockholm
Sweden	Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset	Uppsala
United States	Neurotrials Research Incorporated	Atlanta	Georgia
United States	FutureSearch Trials of Neurology, LP	Austin	Texas
United States	Core Healthcare Group	Cerritos	California
United States	CTI Clinical Research II	Cincinnati	Ohio
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Wesley Neurology Clinic Pc (Multiple Sclerosis)	Cordova	Tennessee
United States	InSite Clinical Research	DeSoto	Texas
United States	Ohio Sleep Medicine Institue	Dublin	Ohio
United States	Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	Precise Research Centers	Flowood	Mississippi
United States	Garden City Asthma and Sleep Center	Garden City	New York
United States	Sleep Disorders Center of the Mid-Atlantic	Glen Burnie	Maryland
United States	Pulmonary Associates, Pa	Glendale	Arizona
United States	Research Carolina of Hickory	Hickory	North Carolina
United States	Hawaii Pacific Neurosciences	Honolulu	Hawaii
United States	Jacksonville Center for Clinical Research	Jacksonville	Texas
United States	Innovative Clinical Research	Lafayette	Colorado
United States	Rowe Neurology Institute	Lenexa	Kansas
United States	Clinical Trials Research	Lincoln	Florida
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Sleep Practitioners, LLC	Macon	Georgia
United States	Cleveland Sleep Research Center	Middleburg Heights	Ohio
United States	Saltzer Clinical Research	Nampa	Idaho
United States	Neurocare Inc.	Newton	Massachusetts
United States	Brian Abaluck LLC	Paoli	Pennsylvania
United States	Wake Research Associates	Raleigh	North Carolina
United States	Artemis Institute For Clinical Research - Riverside	Riverside	California
United States	Clinical Research Group of St. Petersburgh	Saint Petersburg	Florida
United States	Pacific Research Network	San Diego	California
United States	Artemis Institute for Clinical Research	San Marcos	California
United States	Santa Monica Clinical Trials	Santa Monica	California
United States	Dm Clinical Research / Martin Diagnostic Clinic	Tomball	Texas
United States	Noble Clinical Research	Tucson	Arizona
United States	Empire Clinical Research	Upland	California
United States	Clinical Trials of America - NC, LLC	Winston-Salem	North Carolina
United States	Robert V. Sibilia, MD, Inc.	Wooster	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  Czechia,  Finland,  France,  Germany,  Hungary,  Korea, Republic of,  Sweden, 

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)