Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03545191 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
A Phase 3 study of Insomnia Disorder, sponsored by Idorsia Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 930
- Enrollment target
- 20
- Study locations
NCT03545191: Completed Phase 3 study of Insomnia Disorder, sponsored by Idorsia Pharmaceuticals.
NCT03545191 is a Phase 3 study of Insomnia Disorder that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 930 participants, above the 359-participant average among 8 other Insomnia Disorder trials with a reported enrollment target (159% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03545191, a Phase 3 study of Insomnia Disorder, has completed, sponsored by Idorsia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 930 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
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
| Field | Value |
|---|---|
| Enrollment Target | 930 participants |
| Start Date | 2018-06-04 |
| Est. Completion | 2020-02-25 |
| Phase | Phase 3 |
What the finished NCT03545191 record still lists
NCT03545191 is an interventional study that assigns participants to a tested intervention. The registered 930 participants enrollment target is mid-sized for trials with a published cap, above the 359-participant average among 8 other Insomnia Disorder trials with a reported enrollment target (159% higher).
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.
NCT03545191 names 20 study sites across 10 states, led by Florida, California, Alabama.
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.
What interventions are being tested in trial NCT03545191?
The interventions under investigation include: Placebo (OTHER), Daridorexant 50 mg (DRUG), Daridorexant 25 mg (DRUG).
Who is sponsoring clinical trial NCT03545191?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Insomnia Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03545191's enrollment target sits among peer trials
930 2nd of 8 the highest of 8 other Insomnia Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
RECRUITING · Phase 3
-
Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
RECRUITING · NA
-
Assessing Modified CBTi in Adults with Insomnia Disorder
RECRUITING · NA
-
Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2
RECRUITING · NA
-
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
ACTIVE NOT RECRUITING
-
Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05216432 · 930 participants · Phase 1
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer
- NCT06932029 · 930 participants · NA
SMBP Study: Improving High Blood Pressure in Older Adults With Multiple Chronic Diseases
- NCT07235085 · 930 participants · Phase 3
A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy
- NCT06555029 · 929 participants · NA
Oral Health Intervention in Adult Primary Care
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI