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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019413-25 | EudraCT Number |
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Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).
Obstructive sleep apnea (OSA) is a relatively common condition and is estimated to affect 2 to 4% of middle-aged adults
The study medication BF2.649 tested here is a novel, highly potent, selective, orally active inverse agonist at the histamine H3 receptor, therefore strengthens histaminergic transmission in the brain and increases wakefulness EDS is characterized by daytime somnolence and sudden sleep episodes. This problem has several consequences, e.g., an impairment of quality of life, an interference with activities of daily living and other handicaps in the management of social and family affairs.
The primary endpoint of this study will be measured by the change in the well-validated Epworth sleepiness scale (ESS). The ESS is a simple self-administered 8-item questionnaire. The outcome is to get an impression about the level of the daytime sleepiness in several real-life situations.
In this study, each patient will be treated during 2 weeks, and randomly assigned to one the 5 arms (BF2.649 at one of the 4 possible dosages or placebo).
The patient will then attend a end-of-treatment visit, in order to assess the particularly the ESS score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BF2.649 5mg | Experimental |
| |
| BF2.649 10mg | Experimental |
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| BF2.649 20mg | Experimental |
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| BF2.649 40mg | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BF2.649 | Drug | 1 capsule per week during 2 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Epworth Sleepiness Scale scores (ESS) | ESS value compared from baseline (Day 0) and End of treatment period (Day 14) | change of ESS at 2 weeks |
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Main inclusion Criteria:
Main exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evelyne De Paillette, MD | Bioprojet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Grenoble | Grenoble | 38043 | France |
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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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| BF2.649 | Drug | 1 capsule per week during 2 weeks |
|
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| BF2.649 | Drug | 1 capsule per week during 2 weeks |
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| BF2.649 | Drug | 1 capsule per week during 2 weeks |
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| Placebo | Drug | 1 capsule per week during 2 weeks |
|
| 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 |