Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

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

NCT03545191 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG Daridorexant 50 mg
  • DRUG Daridorexant 25 mg

Study Locations (20)

Florida

  • PAB Clinical Research — Brandon
  • St. Francis Sleep Allergy and Lung Institute — Clearwater
  • Innovative Clinical Research, Inc. — Hialeah
  • Research Centers of America — Hollywood
  • Canvas Clinical Research, LLC — Lake Worth
  • BioMed Research Institute — Miami
  • Clinical Site Partners, LLC — Winter Park

California

  • Marvel Clinical Research — Huntington Beach
  • Long Beach Clinical Trials — Long Beach
  • Artemis Institute for Clinical Research — San Diego

Alabama

  • Pinnacle Research Group, LLC — Anniston
  • Pulmonary Associates of the Southeast/WCR — Birmingham

Arkansas

  • Preferred Research Partners, Inc — Little Rock
  • Woodland Research Northwest — Rogers

Indiana

  • LaPorte County Institute for Clinical Research — Michigan City

Kentucky

  • Kentucky Research Group — Louisville

Maryland

  • Helene Emsellem, MD — Chevy Chase

Massachusetts

  • Infinity Medical Research, Inc. — North Dartmouth

Trial Details

FieldValue
Enrollment Target 930 participants
Start Date 2018-06-04
Est. Completion 2020-02-25
Phase Phase 3

Sponsor

Idorsia Pharmaceuticals

38 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03545191

The ClinicalTrials.gov registry entry for NCT03545191 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 930 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Idorsia Pharmaceuticals, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Insomnia Disorder appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03545191 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03545191 about?

NCT03545191 is a clinical study titled "Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder". 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.

What is the current status of trial NCT03545191?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 930 participants. The study started on 2018-06-04. Estimated completion is 2020-02-25.

What conditions does trial NCT03545191 study?

This clinical trial studies the following conditions: Insomnia Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03545191?

The interventions under investigation include: Placebo (OTHER), Daridorexant 50 mg (DRUG), Daridorexant 25 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03545191?

This trial is sponsored by Idorsia Pharmaceuticals, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03545191 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial