Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Public ClinicalTrials.gov record NCT03679884. 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, Parallel-group, Randomized, Placebo-controlled, Three Doses, 40-week Extension to Studies ID-078A301 and ID-078A302 to Assess the Long Term Safety and Tolerability of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
Study identification
- NCT ID
- NCT03679884
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 804 participants
Conditions and interventions
Conditions
Interventions
- Daridorexant 10 mg Drug
- Daridorexant 25 mg Drug
- Daridorexant 50 mg Drug
- Placebo Drug
Drug
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
- Oct 9, 2018 (Actual)
- Primary completion
- Feb 22, 2021 (Actual)
- Completion
- Feb 22, 2021 (Actual)
- Last update posted
- Mar 2, 2022
2018 – 2021
United States locations
- U.S. sites
- 53
- U.S. states
- 22
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pulmonary Associates of the Southeast/WCR | Birmingham | Alabama | 35243 | — |
| Pulmonary Associates, Pa | Glendale | Arizona | 85306 | — |
| Noble Clinical Research | Tucson | Arizona | 85704 | — |
| Preferred Research Partners, Inc | Little Rock | Arkansas | 72211 | — |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | — |
| Core Healthcare Group | Cerritos | California | 90703 | — |
| Marvel Clinical Research | Huntington Beach | California | 92647 | — |
| Clinical Trials Research | Lincoln | California | 95648 | — |
| Long Beach Clinical Trials | Long Beach | California | 90806 | — |
| Artemis Institute For Clinical Research - Riverside | Riverside | California | 92503 | — |
| Artemis institute for Clinical Research | San Diego | California | 92103 | — |
| 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 | — |
| PAB Clinical Research | Brandon | Florida | 33511 | — |
| St. Francis Sleep Allergy and Lung Institute | Clearwater | Florida | 33765 | — |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | — |
| Fleming Island Center for Clinical Research | Fleming Island | Florida | 32003 | — |
| Research Centers of America | Hollywood | Florida | 33024 | — |
| Canvas Clinical Research, LLC | Lake Worth | Florida | 33467 | — |
| BioMed Research Institute | Miami | Florida | 33126 | — |
| Clinical Research Group of St. Petersburgh | St. Petersburg | Florida | 33707 | — |
| Clinical Site Partners, LLC | Winter Park | Florida | 32789 | — |
| Neurotrials Research Incorporated | Atlanta | Georgia | 30342 | — |
| Sleep Practitioners, LLC | Macon | Georgia | 31210 | — |
| Saltzer Clinical Research | Nampa | Idaho | 83686 | — |
| Helene Emsellem, MD | Chevy Chase | Maryland | 20815 | — |
| Sleep Disorders Center of the Mid-Atlantic | Glen Burnie | Maryland | 21061 | — |
| Infinity Medical Research, Inc. | North Dartmouth | Massachusetts | 02747 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
| 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 Hickory | Hickory | North Carolina | 28601 | — |
| Research Carolina of Huntersville | Huntersville | North Carolina | 28078 | — |
| Coastal Carolina Healthcare | New Bern | North Carolina | 28562 | — |
| Wake Research Associates | Raleigh | North Carolina | 27604-1547 | — |
| Clinical Trials of America - NC, LLC | Winston-Salem | North Carolina | 27103 | — |
| CTI Clinical Research II | Cincinnati | Ohio | 45212 | — |
| CTI Clinical Research Center | Cincinnati | Ohio | 45255 | — |
| Aventiv Research Inc. | Dublin | Ohio | 43016 | — |
| Cleveland Sleep Research Center | Middleburg Heights | Ohio | 44130 | — |
| Oregon Center for Clinical Investigations,Inc | Salem | Oregon | 97301 | — |
| Brian Abaluck LLC | Paoli | Pennsylvania | 19301 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| FutureSearch Trials of Neurology, LP | Austin | Texas | 78731 | — |
| Inquest Clinical Research | Baytown | Texas | 77521 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Texas | 32216 | — |
| 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 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03679884, 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 2, 2022 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03679884 live on ClinicalTrials.gov.