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

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

NCT03575104

Run by

Idorsia Pharmaceuticals Ltd.

People needed

924

Starts

2018-05-29

Expected to finish

2020-05-14

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 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.

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

• Noble Clinical Research — Tucson, Arizona, United States
• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• Woodland International Research Group — Little Rock, Arkansas, United States
• Core Healthcare Group — Cerritos, California, United States
• Artemis Institute For Clinical Research - Riverside — Riverside, 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
• Empire Clinical Research — Upland, California, United States
• Innovative Clinical Research — Lafayette, Colorado, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Fleming Island Center for Clinical Research — Fleming Island, Florida, United States
• Clinical Trials Research — Lincoln, Florida, United States
• Clinical Research Group of St. Petersburgh — St. Petersburg, Florida, United States
• Neurotrials Research Incorporated — Atlanta, Georgia, United States
• Sleep Practitioners, LLC — Macon, Georgia, United States
• Hawaii Pacific Neurosciences — Honolulu, Hawaii, United States
• Saltzer Clinical Research — Nampa, Idaho, United States
• Rowe Neurology Institute — Lenexa, Kansas, United States
• Sleep Disorders Center of the Mid-Atlantic — Glen Burnie, Maryland, United States
• Neurocare Inc. — Newton, Massachusetts, United States
• Precise Research Centers — Flowood, Mississippi, United States
• Garden City Asthma and Sleep Center — Garden City, New York, United States
• Research Carolina of Hickory — Hickory, North Carolina, United States
• Pulmonary Associates, Pa — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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