Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Prospective, Randomized, Double-blind Study, Parallel-group, Multi-center Trial Assessing the Effects of Escalating Doses of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolepsy

Conditions
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Narcolepsy, Cataplexy, Excessive Daytime Sleepiness

Intervention / Treatment
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* Drug: BF2.649
* Drug: BF2.649 add on Modafinil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: De novo patients with newly diagnosed narcolespy and cataplexy , and not taking any treatment for Excessive Daytime Sleepiness(EDS) and cataplexy patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months partial or total cataplexy attacks with a frequency of at least 5 per week during a 14 day baseline period and ESS >or= 14 at the end of the baseline period Exclusion Criteria: Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances Current or recent history of a substance abuse or dependence disorder including alcohol abuse Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BF2.649 + Modafinil placebo<br> | Drug: BF2.649<br>* BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks<br>* Other names: Pitolisant;|
| Experimental: BF2.649 + Modafinil<br> | Drug: BF2.649 add on Modafinil<br>* BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks<br>* Other names: Modiodal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cataplexy attacks reported on sleep diary |  | every days from screening visit (day-14) to final visit (day 56) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Epworth Sleepiness Scale (ESS) |  | at each visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Narcolespy, Cataplexy, Excesssive daytime Sleepiness, Sleep Disorders, Sleep attacks, Orphan Drug, Pitolisant