Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
Public ClinicalTrials.gov record NCT03545191. 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
- NCT03545191
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 930 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
- Jun 4, 2018 (Actual)
- Primary completion
- Jan 25, 2020 (Actual)
- Completion
- Feb 25, 2020 (Actual)
- Last update posted
- Mar 25, 2022
2018 – 2020
United States locations
- U.S. sites
- 36
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | — |
| Pulmonary Associates of the Southeast/WCR | Birmingham | Alabama | 35243 | — |
| Preferred Research Partners, Inc | Little Rock | Arkansas | 72211 | — |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | — |
| Marvel Clinical Research | Huntington Beach | California | 92647 | — |
| Long Beach Clinical Trials | Long Beach | California | 90806 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| PAB Clinical Research | Brandon | Florida | 33511 | — |
| St. Francis Sleep Allergy and Lung Institute | Clearwater | Florida | 33765 | — |
| Innovative Clinical Research, Inc. | Hialeah | Florida | 33012 | — |
| Research Centers of America | Hollywood | Florida | 33024 | — |
| Canvas Clinical Research, LLC | Lake Worth | Florida | 33467 | — |
| BioMed Research Institute | Miami | Florida | 33126 | — |
| Clinical Site Partners, LLC | Winter Park | Florida | 32789 | — |
| LaPorte County Institute for Clinical Research | Michigan City | Indiana | 46360 | — |
| Kentucky Research Group | Louisville | Kentucky | 40218 | — |
| Helene Emsellem, MD | Chevy Chase | Maryland | 20815 | — |
| Infinity Medical Research, Inc. | North Dartmouth | Massachusetts | 02747 | — |
| Barrett Clinic | La Vista | Nebraska | 68128 | — |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | — |
| Clinilabs NYC | New York | New York | 10019 | — |
| Research Carolina of Huntersville | Huntersville | North Carolina | 28078 | — |
| Coastal Carolina Healthcare | New Bern | North Carolina | 28562 | — |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | — |
| Oregon Center for Clinical Investigations,Inc | Salem | Oregon | 97301 | — |
| BTC of Lincoln | Lincoln | Rhode Island | 02865 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Bogan Sleep Consulting, LLC | Columbia | South Carolina | 29201 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| Tri-State Mountain Neurology | Johnson City | Tennessee | 37604 | — |
| Inquest Clinical Research | Baytown | Texas | 77521 | — |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | — |
| Aspen Clinical Research | Orem | Utah | 84058 | — |
| Pulmonary Associates of Richmond | Richmond | Virginia | 23225 | — |
| Sleep Disorders Centers of the Mid-Atlantic | Vienna | Virginia | 22182 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
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 45 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03545191, 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 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03545191 live on ClinicalTrials.gov.