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

Conditions

• Insomnia Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Daridorexant 10 mg — DRUG
  Daridorexant 10 mg film-coated tablets
• Daridorexant 25 mg — DRUG
  Daridorexant 25 mg film-coated tablets
• Daridorexant 50 mg — DRUG
  Daridorexant 50 mg film-coated tablets
• Placebo — DRUG
  Matching placebo film-coated tablets

Study Details

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

Key Dates

Start date

Oct 9, 2018

Status verified

Feb 2022

Primary completion

Feb 22, 2021

Completion

Feb 22, 2021

Study Design

Enrollment

804 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Daridorexant 10 mg
  Film-coated tablets administered orally, once daily in the evening
• Experimental: Daridorexant 25 mg
  Film-coated tablets administered orally, once daily in the evening
• Experimental: Daridorexant 50 mg
  Film-coated tablets administered orally, once daily in the evening
• Placebo Comparator: Placebo
  Film-coated tablets administered orally, once daily in the evening
• Experimental: Ex-Placebo Daridorexant 25 mg
  Film-coated tablets administered orally, once daily in the evening

Primary Outcome Measure

Total no. of Subjects With at Least One TEAE [ Time Frame: TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks. ]

Locations (53)

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