Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)

Detailed Description
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BF 2.649, a new experimental drug, significantly decreases, in patient with narcolepsy, the excessive daytime sleepiness (EDS) evaluated by Epworth Sleepiness Scale (ESS), according the results of two previous clinical studies. The objective of this study is to determine the efficacy and safety of BF2.649 administered by escalating dose (10, 20 or 40 mg/d) in narcoleptic patients with excessive daytime sleepiness versus placebo and Modafinil as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary. 60 patients with narcolepsy with or without cataplexy will be included.

Official Title
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Prospective, Randomized, Double-blind Study, Placebo-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in Treatment of Excessive Daytime Sleepiness in Narcolepsy

Conditions
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Narcolepsy, Excessive Daytime Sleepiness, Cataplexy, Sleep Disorders

Intervention / Treatment
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* Drug: BF2.649
* Drug: Modafinil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of narcolepsy with or without cataplexy patients need to free of or discontinue psychostimulant medications for at least 14 days, patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses patients must have adequate support to comply with the entire study requirements Exclusion Criteria: Other conditions than Narcolepsy that can be considered as the primary causes of excessive daytime sleepiness Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances 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 Current or recent history of a substance abuse or dependence disorder including alcohol abuse

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<br> | Drug: BF2.649<br>* BF2.649 oral capsules at 10 or 20 or 40 mg per day<br>* Other names: Pitolisant;|
| Active Comparator: Modafinil<br> | Drug: Modafinil<br>* Modafinil oral capsules at 100 or 200 or 400 mg per day<br>* Other names: Modiodal;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo oral capsules, 4 capsules per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epworth Sleepiness Scale (ESS) |  | between baseline and at the end of 8 week DB phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks |  | 14 days before randomization and 7 days before each visit | 
| Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART). |  | at inclusion and after 8-week treatment | 

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