drugset / Trial / NCT05223166

A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA

NCT05223166

Phase 3 Completed 240 enrolled Citrine Medicine Limited
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to demonstrate the efficacy and safety of pitolisant versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea (OSA) not tolerating or refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by nCPAP but still complaining of EDS.

Timeline

Start
2022-04-12
Primary completion
2023-07-18
Completion
2023-07-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Pitolisant Small molecule

Indications