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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013886-24 | EudraCT Number |
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To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.
As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at Week 51, in patients diagnosed with EDS in Parkinson's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BF2.649 ( Pitolisant) | Experimental | BF2.649 (5mg, 10 mg, 20 mg) in capsules |
|
| Placebo | Placebo Comparator | Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BF2.649 (Pitolisant) | Drug | 1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D |
|
| Measure | Description | Time Frame |
|---|---|---|
| ESS change (Epworth Sleepiness Scale) versus baseline | at week 12 / 51 versus baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Any AE observed and reported during the study | 12-week and 52-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kati Gutierrez, PharmD | Bioprojet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Neurologie Universitätsklinikum | Marburg | 35039 | Germany |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C516975 | pitolisant |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |