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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017248-14 | EudraCT Number |
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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 5mg, 10 mg, 20mg |
|
| 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 in the morning before breakfast |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| ESS change (Epworth Sleepiness Scale) | at week 12 /52 versus baseline |
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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 |
|---|---|---|---|---|---|---|
| CHU Grenoble | Grenoble | 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. | |
| 33121980 | Derived | 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. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D006970 | Disorders of Excessive Somnolence |
| D012893 | Sleep Wake Disorders |
| 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 in the morning before breakfast |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |