Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Public ClinicalTrials.gov record NCT03575104. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03575104
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 924 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 29, 2018 (Actual)
- Primary completion
- Apr 9, 2020 (Actual)
- Completion
- May 14, 2020 (Actual)
- Last update posted
- Mar 25, 2022
2018 – 2020
United States locations
- U.S. sites
- 37
- U.S. states
- 18
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pulmonary Associates, Pa | Glendale | Arizona | 85306 | — |
| Noble Clinical Research | Tucson | Arizona | 85704 | — |
| Baptist Health Center for Clinical Research | Little Rock | Arkansas | 72205 | — |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | — |
| Core Healthcare Group | Cerritos | California | 90703 | — |
| Artemis Institute For Clinical Research - Riverside | Riverside | California | 92503 | — |
| Pacific Research Network | San Diego | California | 92103 | — |
| Artemis Institute for Clinical Research | San Marcos | California | 92078 | — |
| Santa Monica Clinical Trials | Santa Monica | California | 90404 | — |
| Empire Clinical Research | Upland | California | 91786 | — |
| Innovative Clinical Research | Lafayette | Colorado | 80026 | — |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | — |
| Fleming Island Center for Clinical Research | Fleming Island | Florida | 32003 | — |
| Clinical Trials Research | Lincoln | Florida | 95648 | — |
| Clinical Research Group of St. Petersburgh | St. Petersburg | Florida | 33707 | — |
| Neurotrials Research Incorporated | Atlanta | Georgia | 30342 | — |
| Sleep Practitioners, LLC | Macon | Georgia | 31210 | — |
| Hawaii Pacific Neurosciences | Honolulu | Hawaii | 96817 | — |
| Saltzer Clinical Research | Nampa | Idaho | 83686 | — |
| Rowe Neurology Institute | Lenexa | Kansas | 66214 | — |
| Sleep Disorders Center of the Mid-Atlantic | Glen Burnie | Maryland | 21061 | — |
| Neurocare Inc. | Newton | Massachusetts | 02459 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
| Garden City Asthma and Sleep Center | Garden City | New York | 11530 | — |
| Research Carolina of Hickory | Hickory | North Carolina | 28601 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| Clinical Trials of America - NC, LLC | Winston-Salem | North Carolina | 27103 | — |
| CTI Clinical Research II | Cincinnati | Ohio | 45212 | — |
| Ohio Sleep Medicine Institue | Dublin | Ohio | 43017 | — |
| Cleveland Sleep Research Center | Middleburg Heights | Ohio | 44130 | — |
| Robert V. Sibilia, MD, Inc. | Wooster | Ohio | 44691 | — |
| Brian Abaluck LLC | Paoli | Pennsylvania | 19301 | — |
| Wesley Neurology Clinic Pc (Multiple Sclerosis) | Cordova | Tennessee | 38018 | — |
| FutureSearch Trials of Neurology, LP | Austin | Texas | 78731 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Texas | 32216 | — |
| Dm Clinical Research / Martin Diagnostic Clinic | Tomball | Texas | 77375 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 49 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03575104, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 25, 2022 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03575104 live on ClinicalTrials.gov.