Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA
Status:
Completed
Trial end date:
2020-04-01
Target enrollment:
Participant gender:
Summary
The first objective of this study is to demonstrate the efficacy and safety of pitolisant
given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period,
to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea
(OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by
nCPAP but still complaining of EDS.
The secondary objectives of the study include assessing the long-term tolerance as well as
the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks of
Open Label Extension period and further investigating the co-variates or co-medications that
affect the pharmacokinetics of pitolisant in the target population.