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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03575104
Recruitment Status : Active, not recruiting
First Posted : July 2, 2018
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
The main purpose of this Phase 3 study is to evaluate the efficacy of 10 mg and 25 mg ACT-541468 on objective sleep parameters in subjects with insomnia disorder.

Condition or disease Intervention/treatment Phase
Insomnia Disorder Drug: ACT-541468 Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 924 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : April 25, 2020
Estimated Study Completion Date : May 25, 2020

Arm Intervention/treatment
Experimental: ACT-541468 10 mg
ACT-541468 will be administered as tablets, orally, once daily in the evening.
Drug: ACT-541468
Administered orally as tablets.

Experimental: ACT-541468 25 mg
ACT-541468 will be administered as tablets, orally, once daily in the evening.
Drug: ACT-541468
Administered orally as tablets.

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




Primary Outcome Measures :
  1. Change from baseline to Month 1 in Wake After Sleep Onset (WASO) (sleep maintenance) [ Time Frame: From baseline to Month 1 (i.e. for up to 1 month) ]
    WASO is the time (min) spent awake after onset of persistent sleep until lights on, as determined by polysomnography (PSG).

  2. Change from baseline to Month 3 in Wake After Sleep Onset (WASO) [ Time Frame: From baseline to Month 3 (i.e. for up to 3 months) ]
    WASO is the time (min) spent awake after onset of persistent sleep until lights on, as determined by polysomnography (PSG).

  3. Change from baseline to Month 1 in Latency to Persistent Sleep (LPS) (sleep onset) [ Time Frame: From baseline to Month 1 (i.e. for up to 1 month) ]
    LPS (min) is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 min) 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 (PSG).

  4. Change from baseline to Month 3 in Latency to Persistent Sleep (LPS) [ Time Frame: From baseline to Month 3 (i.e. for up to 3 months) ]
    LPS (min) is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 min) 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 (PSG).


Secondary Outcome Measures :
  1. Change from baseline to Month 1 in the subjective Total Sleep Time (sTST) [ Time Frame: From baseline to Month 1 (i.e. for up to 1 month) ]
  2. Change from baseline to Month 3 in the subjective Total Sleep Time (sTST) [ Time Frame: From baseline to Month 3 (i.e. for up to 3 months) ]
  3. Change from baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) sleepiness domain score [ Time Frame: From baseline to Month 1 (i.e. for up to 1 month) ]
  4. Change from baseline to Month 3 in IDSIQ sleepiness domain score [ Time Frame: From baseline to Month 3 (i.e. for up to 3 months) ]

Other Outcome Measures:
  1. Number of subjects with (serious) adverse events [ Time Frame: SAE and AE reporting and follow-up: all SAEs and AEs from signed ICF up to 30 days after double-blind study drug discontinuation. For up to approx. 132 to 154 days in total. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575104


Locations
Hide Hide 86 study locations
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United States, Arizona
Pulmonary Associates, Pa
Glendale, Arizona, United States, 85306
Noble Clinical Research
Tucson, Arizona, United States, 85704
United States, Arkansas
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
United States, California
Core Healthcare Group
Cerritos, California, United States, 90703
Artemis Institute For Clinical Research - Riverside
Riverside, California, United States, 92503
Pacific Research Network
San Diego, California, United States, 92103
Artemis Institute for Clinical Research
San Marcos, California, United States, 92078
Santa Monica Clinical Trials
Santa Monica, California, United States, 90404
Empire Clinical Research
Upland, California, United States, 91786
United States, Colorado
Innovative Clinical Research
Lafayette, Colorado, United States, 80026
United States, Florida
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States, 32003
Clinical Trials Research
Lincoln, Florida, United States, 95648
Clinical Research Group of St. Petersburgh
Saint Petersburg, Florida, United States, 33707
United States, Georgia
Neurotrials Research Incorporated
Atlanta, Georgia, United States, 30342
Sleep Practitioners, LLC
Macon, Georgia, United States, 31210
United States, Hawaii
Hawaii Pacific Neurosciences
Honolulu, Hawaii, United States, 96817
United States, Idaho
Saltzer Clinical Research
Nampa, Idaho, United States, 83686
United States, Kansas
Rowe Neurology Institute
Lenexa, Kansas, United States, 66214
United States, Maryland
Sleep Disorders Center of the Mid-Atlantic
Glen Burnie, Maryland, United States, 21061
United States, Massachusetts
Neurocare Inc.
Newton, Massachusetts, United States, 02459
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, New York
Garden City Asthma and Sleep Center
Garden City, New York, United States, 11530
United States, North Carolina
Research Carolina of Hickory
Hickory, North Carolina, United States, 28601
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Clinical Trials of America - NC, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
CTI Clinical Research II
Cincinnati, Ohio, United States, 45212
Ohio Sleep Medicine Institue
Dublin, Ohio, United States, 43017
Cleveland Sleep Research Center
Middleburg Heights, Ohio, United States, 44130
Robert V. Sibilia, MD, Inc.
Wooster, Ohio, United States, 44691
United States, Pennsylvania
Brian Abaluck LLC
Paoli, Pennsylvania, United States, 19301
United States, Tennessee
Wesley Neurology Clinic Pc (Multiple Sclerosis)
Cordova, Tennessee, United States, 38018
United States, Texas
FutureSearch Trials of Neurology, LP
Austin, Texas, United States, 78731
InSite Clinical Research
DeSoto, Texas, United States, 75115
Jacksonville Center for Clinical Research
Jacksonville, Texas, United States, 32216
Dm Clinical Research / Martin Diagnostic Clinic
Tomball, Texas, United States, 77375
Belgium
HOSPITAL AZ SINT-JAN_Neurology department
Brugge, Belgium, 8000
Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory
Brussels, Belgium, 1090
University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring
Gent, Belgium, 9000
Hospital UZ Leuven_ Pneumology Department
Leuven, Belgium, 3000
Bulgaria
Acibadem City Clinic Tokuda Hospital EAD
Sofia, Bulgaria, 1407
Canada, Ontario
Canadian Phase Onward Inc.
Toronto, Ontario, Canada, M3J 2C5
Canada
Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1
Etobicoke, Canada, M9C 5N2
The Medical Arts Health Research Group
Kelowna, Canada, V1Y 3G8
Somni Research Inc.
Markham, Canada, L3R 1A3
Somni Research, Calgary
Toronto, Canada, M3H 3W1
CANADIAN PHASE ONWARD INC. (Toronto)
Toronto, Canada, M3J 0K2
Czechia
Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health)
Klecany, Czechia
Fakultní nemocnice Ostrava, Spánková laboratoř
Ostrava-Poruba, Czechia, 70852
Nemocnice České Budějovice, Centrum pro poruchy spánku a spánkovou medicínu
České Budějovice, Czechia, 37087
Finland
Vitalmed Uniklinikka
Helsinki, Finland, 380
Oivauni Oy - Kuopio
Kuopio, Finland, 70100
Oivauni Oy - Tampere
Tampere, Finland
Unitutkimusyksikkö, Turun Yliopisto
Turku, Finland
France
CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique
Lille, France, 59037
Clinique beau soleil - Department Sleep and Neurology
Montpellier, France
CHU NIMES - Unité de Sommeil
Nîmes, France, 30029
Germany
Advanced Sleep Research GmbH
Berlin, Germany, 10117
Klinische Forschung Berlin-Mitte GmbH
Berlin, Germany, 10117
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
Berlin, Germany, 12200
Synexus Clinical Research GmbH
Bochum, Germany, 44787
Klinische Forschung Dresden GmbH
Dresden, Germany, 1069
Synexus Clinical Research GmbH
Frankfurt, Germany, 60313
Klinische Forschung Hannover Mitte GmbH
Hannover, Germany, 30159
Interdisziplinäre Schlafmedizin, Pfalzklinikum
Klingenmünster, Germany, 76889
Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck
Lübeck, Germany, 23538
Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University
Mannheim, Germany, 68159
Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg
Regensburg, Germany, 93053
SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, Germany, 19053
Hungary
Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály
Budapest, Hungary, 1134
Somnius Kft. SomnoCenter Szeged
Szeged, Hungary, 6725
Korea, Republic of
Dong-A University Hospital
Busan, Korea, Republic of, 49201
4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
Daegu, Korea, Republic of, 41931
Chungnam National University Hospital
Daejeon, Korea, Republic of, 35015
3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu
Gwangju, Korea, Republic of, 61469
8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu
Seongnam, Korea, Republic of, 13620
3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu
Seoul, Korea, Republic of, 3080
1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu
Seoul, Korea, Republic of, 3722
B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu
Seoul, Korea, Republic of, 5030
B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu
Seoul, Korea, Republic of, 5278
2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu
Suwon, Korea, Republic of, 16247
Sweden
Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
Göteborg, Sweden, 41390
SOPHIAHEMMET (Stockholm)
Stockholm, Sweden, 11486
Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset
Uppsala, Sweden, 75185
Universitetssjukhuset Örebro Neurokliniken, Sömnenheten
Örebro, Sweden, 70185
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.

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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03575104    
Other Study ID Numbers: ID-078A302
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders