drugset / Trial / NCT05597020

A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia

NCT05597020 ↗

Phase 4 Completed 60 enrolled Idorsia Pharmaceuticals Ltd.
RandomizedCrossoverQuadruple-blindTreatment

Summary

A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia

Timeline

Start
2023-02-16
Primary completion
2024-04-12
Completion
2024-04-18

Outcome

Met primary endpoint

registry analysis (superiority test); Daridorexant 50 mg vs Placebo; p = 0.002; Least Square mean difference vs placebo 20.9 (95% CI 8.0 to 33.7) NCT05597020 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Daridorexant Small molecule 50 mg Oral

Indications