NCT03679884

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 804 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Insomnia Disorder

Interventions

Type	Name	Description
DRUG	Daridorexant 10 mg	Daridorexant 10 mg film-coated tablets
DRUG	Daridorexant 25 mg	Daridorexant 25 mg film-coated tablets
DRUG	Daridorexant 50 mg	Daridorexant 50 mg film-coated tablets
DRUG	Placebo	Matching placebo film-coated tablets

Timeline

• Start date: 2018-10-09
• Primary completion: 2021-02-22
• Completion: 2021-02-22
• First posted: 2018-09-21
• Last updated: 2022-03-02
• Results posted: 2022-03-02

Locations

106 sites across 14 countries: United States, Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, Hungary, Poland, South Korea, Spain, Sweden, Switzerland

Regulatory

• FDA-regulated drug study