Trial Profile
BF2.649 in patients with Obstructive Sleep Apnoea syndrome (OSA), and treated by nasal Continuous Positive Airway Pressure (nCPAP), but still complaining of Excessive Daytime Sleepiness (EDS).
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 23 Nov 2023
Price :
$35
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At a glance
- Drugs Pitolisant (Primary) ; Modafinil
- Indications Sleep apnoea syndrome
- Focus Registrational; Therapeutic Use
- Acronyms HAROSA I
- Sponsors Bioprojet
- 16 Nov 2023 Results assessing long-term efficacy and safety of pitolisant for residual sleepiness due to obstructive sleep apnea in HAROSA-1 & HAROSA-2 trials, published in the Chest.
- 02 Dec 2021 Results of meta-analysis of individual patient data from two studies (HAROSA-1 & HAROSA-2) assessing efficacy and safety of pitolisant 20 mg in patients with OSA, published in the Clinical Drug Investigation.
- 03 Sep 2021 According to a Renovacor media release, The European Medicines Agency has issued a marketing authorisation for OZAWADE (pitolisant), indicated in the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea in adults.