NCT05223166

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

A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Citrine Medicine Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Excessive Daytime Sleepiness

Interventions

Type	Name	Description
DRUG	Pitolisant	Wakix tablet
DRUG	Placebo oral tablet	Matching placebo tablets will be provided for each strength of active pitolisant film-coated tablets.

Timeline

• Start date: 2022-04-12
• Primary completion: 2023-07-18
• Completion: 2023-07-18
• First posted: 2022-02-03
• Last updated: 2023-07-20

Locations

1 site across 1 country: China