NCT03545191

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 930 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

Conditions

• Insomnia Disorder

Interventions

Type	Name	Description
DRUG	Daridorexant 25 mg	Daridorexant will be administered as tablets, orally, once daily in the evening.
DRUG	Daridorexant 50 mg	Daridorexant will be administered as tablets, orally, once daily in the evening.
OTHER	Placebo	Matching placebo will be administered as tablets, orally, once daily in the evening.

Timeline

• Start date: 2018-06-04
• Primary completion: 2020-01-25
• Completion: 2020-02-25
• First posted: 2018-06-04
• Last updated: 2022-03-25
• Results posted: 2022-03-25

Locations

81 sites across 10 countries: United States, Australia, Canada, Denmark, Germany, Italy, Poland, Serbia, Spain, Switzerland

Regulatory

• FDA-regulated drug study