drugset / Trial / NCT01071876
BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose. This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.
Timeline
- Start
- 2011-08
- Primary completion
- 2014-03
- Completion
- 2014-03
Publications
- Pepin JL, Attali V, Causse C, Verbraecken J, Hedner J, Lecomte I, Tamisier R, Levy P, Lehert P, Dauvilliers Y. Long-Term Efficacy and Safety of Pitolisant for Residual Sleepiness Due to OSA. Chest. 2024 Mar;165(3):692-703. doi: 10.1016/j.chest.2023.11.017. Epub 2023 Nov 17.
- Pepin JL, Georgiev O, Tiholov R, Attali V, Verbraecken J, Buyse B, Partinen M, Fietze I, Belev G, Dokic D, Tamisier R, Levy P, Lecomte I, Lecomte JM, Schwartz JC, Dauvilliers Y; HAROSA I Study Group. Pitolisant for Residual Excessive Daytime Sleepiness in OSA Patients Adhering to CPAP: A Randomized Trial. Chest. 2021 Apr;159(4):1598-1609. doi: 10.1016/j.chest.2020.09.281. Epub 2020 Oct 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pitolisant | Small molecule | 5 mg | Oral |
| Subject | Pitolisant | Small molecule | 10 mg | Oral |
| Subject | Pitolisant | Small molecule | 20 mg | Oral |