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

Completed · Phase 3 · Has a placebo group

Conditions studied: Insomnia Disorder

In brief

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.

Key facts

Study ID

NCT03545191

Run by

Idorsia Pharmaceuticals Ltd.

People needed

930

Starts

2018-06-04

Expected to finish

2020-02-25

Last updated by the study team

2022-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pulmonary Associates of the Southeast/WCR — Birmingham, Alabama, United States
• Preferred Research Partners, Inc — Little Rock, Arkansas, United States
• Woodland Research Northwest — Rogers, Arkansas, United States
• Marvel Clinical Research — Huntington Beach, California, United States
• Long Beach Clinical Trials — Long Beach, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• PAB Clinical Research — Brandon, Florida, United States
• St. Francis Sleep Allergy and Lung Institute — Clearwater, Florida, United States
• Innovative Clinical Research, Inc. — Hialeah, Florida, United States
• Research Centers of America — Hollywood, Florida, United States
• Canvas Clinical Research, LLC — Lake Worth, Florida, United States
• BioMed Research Institute — Miami, Florida, United States
• Clinical Site Partners, LLC — Winter Park, Florida, United States
• LaPorte County Institute for Clinical Research — Michigan City, Indiana, United States
• Kentucky Research Group — Louisville, Kentucky, United States
• Helene Emsellem, MD — Chevy Chase, Maryland, United States
• Infinity Medical Research, Inc. — North Dartmouth, Massachusetts, United States
• Barrett Clinic — La Vista, Nebraska, United States
• Clinical Research Center of Nevada — Las Vegas, Nevada, United States
• Clinilabs NYC — New York, New York, United States
• Research Carolina of Huntersville — Huntersville, North Carolina, United States
• Coastal Carolina Healthcare — New Bern, North Carolina, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States
• Oregon Center for Clinical Investigations,Inc — Salem, Oregon, United States
• Pinnacle Research Group, LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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