drugset / Trial / NCT05223166
A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pitolisant | Small molecule | — | — |