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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007845-29 | EudraCT Number |
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The objective of this study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy
BF 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies.
The objective of this POC study are firstly to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil (200 mg/day) on cataplexy attacks, and secondly to evaluate the additive/synergistic effect and safety of the combination of BF2.649 and Modafinil on EDS as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BF2.649 + Modafinil placebo | Experimental |
| |
| BF2.649 + Modafinil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BF2.649 | Drug | BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cataplexy attacks reported on sleep diary | every days from screening visit (day-14) to final visit (day 56) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Diary: number and duration of diurnal sleep and sleepiness episodes, | every days from screening visit (day-14) to final visit (day 56) | |
| Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART). | at inclusion and after 8-week treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Bassetti | Neurocenter of Southern Switzerland,Lugano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurocenter (EOC) of Southern Switzerland | Lugano | 6903 | Switzerland |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D002385 | Cataplexy |
| D006970 | Disorders of Excessive Somnolence |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C516975 | pitolisant |
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| BF2.649 add on Modafinil | Drug | BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks |
|
|
| Epworth Sleepiness Scale (ESS) | at each visit |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |