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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.
The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo.
The aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BF2.649 | Experimental | BF2.649 capsules dosed at 5 mg, 10 mg, 20 mg |
|
| Placebo | Placebo Comparator | Capsules of placebo containing lactose with low, medium and high dosage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BF2.649 | Drug | 1 capsule per day in the morning before the breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| ESS (Epworth Sleepiness Scale) change from baseline | From baseline to week 12 and week 51 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evelyne De Paillette, MD | Bioprojet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Grenoble | Grenoble | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37979718 | Derived | 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. | |
| 31917607 | Derived | Dauvilliers Y, Verbraecken J, Partinen M, Hedner J, Saaresranta T, Georgiev O, Tiholov R, Lecomte I, Tamisier R, Levy P, Scart-Gres C, Lecomte JM, Schwartz JC, Pepin JL; HAROSA II Study Group collaborators. Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial. Am J Respir Crit Care Med. 2020 May 1;201(9):1135-1145. doi: 10.1164/rccm.201907-1284OC. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C516975 | pitolisant |
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| Placebo | Drug | 1 capsule per day in the morning before the breakfast |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |