Phase 3
Completed N=801
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Source: ClinicalTrials.gov NCT03679884 ↗Enrolled (actual)
801
Serious AEs
3.8%
Results posted
Mar 2022
Primary outcomePrimary: Total no. of Subjects With at Least One TEAE — 53; 103; 55; 45 Participants
◆ Published Evidence
Established
92citations · ~31 / year
Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder.
Summary
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
Linked Publications (2)
-
Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder.
-
Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total no. of Subjects With at Least One TEAE |
53; 103; 55; 45; 48 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent prior to any study-mandated procedure (Visit 1).
- Having completed the DB study treatment and the run-out period of ID-078A301 (NCT03545191) or ID-078A302 (NCT03575104).
- For woman of childbearing potential, the following is required:
- Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)
- Agreement to use the contraception scheme as required by the protocol from Visit 1 up to at least 30 days after EODBT.
Exclusion Criteria
- Unstable medical condition, significant medical disorder or acute illness, C-SSRS©, ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in the opinion of the investigator could affect the subject's safety or interfere with the study assessments (Visit 1).
- For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1).
- Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or Visit 1 if within 7 days after EOT).
Data sourced from ClinicalTrials.gov (NCT03679884) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.