Study to Assess the Long Term Safety and Tolerability 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

Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep

Key facts

Study ID

NCT03679884

Run by

Idorsia Pharmaceuticals Ltd.

People needed

804

Starts

2018-10-09

Expected to finish

2021-02-22

Last updated by the study team

2022-03-02

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 (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.

You may not qualify if…

• 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).

Where it is running

• Pulmonary Associates, Pa — Glendale, Arizona, United States
• Noble Clinical Research — Tucson, Arizona, United States
• Preferred Research Partners, Inc — Little Rock, Arkansas, United States
• Woodland International Research Group — Little Rock, Arkansas, United States
• Core Healthcare Group — Cerritos, California, United States
• Marvel Clinical Research — Huntington Beach, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Long Beach Clinical Trials — Long Beach, California, United States
• Artemis Institute For Clinical Research - Riverside — Riverside, California, 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
• Empire Clinical Research — Upland, California, United States
• Innovative Clinical Research — Lafayette, Colorado, United States
• PAB Clinical Research — Brandon, Florida, United States
• St. Francis Sleep Allergy and Lung Institute — Clearwater, Florida, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Fleming Island Center for Clinical Research — Fleming Island, 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 Research Group of St. Petersburgh — St. Petersburg, Florida, United States
• Clinical Site Partners, LLC — Winter Park, Florida, United States
• Pulmonary Associates of the Southeast/WCR — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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