Insomnia Disorder Clinical Trial
Official title:
Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled, Three Doses, 40-week Extension to Studies ID-078A301 and ID-078A302 to Assess the Long Term Safety and Tolerability of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
Verified date | February 2022 |
Source | Idorsia Pharmaceuticals Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
Status | Completed |
Enrollment | 804 |
Est. completion date | February 22, 2021 |
Est. primary completion date | February 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Signed informed consent prior to any study-mandated procedure (Visit 1). - Having completed the DB study treatment and the run-out period of ID-078A301 (NCT03545191) or ID-078A302 (NCT03575104). - For woman of childbearing potential, the following is required: - Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies) - Agreement to use the contraception scheme as required by the protocol from Visit 1 up to at least 30 days after EODBT. Exclusion Criteria: - Unstable medical condition, significant medical disorder or acute illness, C-SSRS©, ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in the opinion of the investigator could affect the subject's safety or interfere with the study assessments (Visit 1). - For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1). - Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or Visit 1 if within 7 days after EOT). |
Country | Name | City | State |
---|---|---|---|
Belgium | Hospital UZ Leuven_ Pneumology Department | Leuven | |
Bulgaria | Acibadem City Clinic Tokuda Hospital EAD | Sofia | |
Canada | Queensway Sleep Lab Sleep Clinic (MedSleep) | Etobicoke | |
Canada | The Medical Arts Health Research Group | Kelowna | |
Canada | Somni Research Inc. | Markham | |
Canada | CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil) | Quebec | |
Canada | CANADIAN PHASE ONWARD INC. (Toronto) | Toronto | |
Canada | Jodha Tishon Inc. | Toronto | |
Canada | MedSleep | Toronto | |
Denmark | Scan Sleep Specialists | København | |
Finland | Vitalmed Uniklinikka | Helsinki | |
Finland | Oivauni Oy - Kuopio | Kuopio | |
Finland | Oivauni Oy - Tampere | Tampere | |
Finland | Unitutkimusyksikkö, Turun Yliopisto | Turku | |
France | CHU NIMES - Unité de Sommeil | Nîmes | |
Germany | Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin | Berlin | |
Germany | emovis GmbH | Berlin | |
Germany | Klinische Forschung Berlin-Mitte GmbH | Berlin | |
Germany | St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin | Berlin | |
Germany | Synexus Berlin Research Centre | Berlin | |
Germany | Synexus Clinical Research GmbH | Bochum | |
Germany | Klinik imd Poliklinik fur Neurochirurgie | Dresden | |
Germany | Klinische Forschung Dresden GmbH | Dresden | |
Germany | Synexus Clinical Research GmbH | Frankfurt | |
Germany | Clinical Trial Center North GmbH & Co. KG | Hamburg | |
Germany | Klinische Forschung Hamburg GmbH | Hamburg | |
Germany | Klinische Forschung Hannover Mitte GmbH | Hannover | |
Germany | Klinische Forschung Karlsruhe GmbH | Karlsruhe | |
Germany | Studienzentrum Wilhelmshöhe GmbH | Kassel | |
Germany | Synexus Leipzig Research Centre | Leipzig | |
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 | Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy | München | |
Germany | Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg | Regensburg | |
Germany | Kinische Forschung Schwerin GmbH | Schwerin | |
Germany | SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH | Schwerin | |
Germany | ZMS Zentrum für medizinische Studien GmbH | Warendorf | |
Hungary | Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály | Budapest | |
Hungary | Somnius Kft. SomnoCenter Szeged | Szeged | |
Korea, Republic of | 4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu | Daegu | |
Korea, Republic of | 2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu | Suwon | |
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 | |
Spain | Centro Médico Teknon - Medicina del Sueño | Barcelona | |
Spain | Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit | Barcelona | |
Spain | Instituto de Investigaciones del Sueno | Madrid | |
Spain | Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño | Vitoria-Gasteiz | |
Spain | Hospital MAZ - Neurophisiology and Sleep Department | Zaragoza | |
Sweden | Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar | Göteborg | |
Sweden | Universitetssjukhuset Örebro Neurokliniken, Sömnenheten | Örebro | |
Sweden | Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset | Uppsala | |
Switzerland | Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald | Wald | |
United States | Neurotrials Research Incorporated | Atlanta | Georgia |
United States | FutureSearch Trials of Neurology, LP | Austin | Texas |
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 | Core Healthcare Group | Cerritos | California |
United States | Helene Emsellem, MD | Chevy Chase | Maryland |
United States | CTI Clinical Research Center | Cincinnati | Ohio |
United States | CTI Clinical Research II | Cincinnati | Ohio |
United States | St. Francis Sleep Allergy and Lung Institute | Clearwater | Florida |
United States | Clinical Research of South Florida | Coral Gables | Florida |
United States | InSite Clinical Research | DeSoto | Texas |
United States | Aventiv Research Inc. | Dublin | Ohio |
United States | Fleming Island Center for Clinical Research | Fleming Island | Florida |
United States | Precise Research Centers | Flowood | Mississippi |
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 | 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 | Jacksonville Center for Clinical Research | Jacksonville | Texas |
United States | Barrett Clinic | La Vista | Nebraska |
United States | Innovative Clinical Research | Lafayette | Colorado |
United States | Canvas Clinical Research, LLC | Lake Worth | Florida |
United States | Clinical Research Center of Nevada | Las Vegas | Nevada |
United States | Clinical Trials Research | Lincoln | California |
United States | Preferred Research Partners, Inc | Little Rock | Arkansas |
United States | Woodland International Research Group | Little Rock | Arkansas |
United States | Long Beach Clinical Trials | Long Beach | California |
United States | Sleep Practitioners, LLC | Macon | Georgia |
United States | BioMed Research Institute | Miami | Florida |
United States | Cleveland Sleep Research Center | Middleburg Heights | Ohio |
United States | Saltzer Clinical Research | Nampa | Idaho |
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 | 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 | Oregon Center for Clinical Investigations,Inc | Salem | Oregon |
United States | Artemis institute for Clinical Research | San Diego | California |
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 | Swedish Medical Center | Seattle | Washington |
United States | Noble Clinical Research | Tucson | Arizona |
United States | Empire Clinical Research | Upland | California |
United States | Sleep Disorders Centers of the Mid-Atlantic | Vienna | Virginia |
United States | Omega Medical Research | Warwick | Rhode Island |
United States | Clinical Trials of America - NC, LLC | Winston-Salem | North Carolina |
United States | Clinical Site Partners, LLC | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Idorsia Pharmaceuticals Ltd. |
United States, Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, Hungary, Korea, Republic of, Poland, Spain, Sweden, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total no. of Subjects With at Least One TEAE | The primary objective of the study was to assess the long-term safety and tolerability of 10, 25 and 50 mg daridorexant.
The total no. of subjects with at least one TEAE is presented here; no statistical analysis was conducted. The full set of safety data is available in the Section "Adverse events". |
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks. |
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