Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Insomnia Disorder

Treatments: Drug: Daridorexant 25 mg; Drug: Daridorexant 10 mg; Drug: Placebo; Drug: Daridorexant 50 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03679884

ID-078A303

Details and patient eligibility

About

Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep

Enrollment: 804 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

804 participants in 5 patient groups, including a placebo group

Daridorexant 10 mg

Experimental group

Description:

Film-coated tablets administered orally, once daily in the evening

Treatment:

Drug: Daridorexant 10 mg

Daridorexant 25 mg

Experimental group

Description:

Film-coated tablets administered orally, once daily in the evening

Treatment:

Drug: Daridorexant 25 mg

Daridorexant 50 mg

Experimental group

Description:

Film-coated tablets administered orally, once daily in the evening

Treatment:

Drug: Daridorexant 50 mg

Placebo

Placebo Comparator group

Description:

Film-coated tablets administered orally, once daily in the evening

Treatment:

Drug: Placebo

Ex-Placebo Daridorexant 25 mg

Experimental group

Description:

Film-coated tablets administered orally, once daily in the evening

Treatment:

Drug: Daridorexant 25 mg