Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)

Study Overview
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Brief Summary
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Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).

Detailed Description
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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.

Official Title
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Minimum Effective Dose-Finding Study of BF2.649, in Patients With Moderate to Severe OSA, Experiencing EDS Despite Regular Use of nCPAP, and Patients Having Refused This Therapy - Randomized, Double Blind Study With BF2.649 or Placebo

Conditions
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Obstructive Sleep Apnoea, Excessive Daytime Sleepiness

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


Participation Criteria
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Eligibility Criteria
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Main inclusion Criteria: Patient with OSA (treated or not with nCPAP) and still complaining of EDS Epworth Sleepiness Scale score > or = to 11 Main exclusion Criteria: Patient suffering from chronic severe insomnia in accordance with the International Classification of Sleep Disorders, but without OSA

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 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 5mg<br> | Drug: BF2.649<br>* 1 capsule per week during 2 weeks<br>* Other names: Pitolisant;|
| Experimental: BF2.649 10mg<br> | Drug: BF2.649<br>* 1 capsule per week during 2 weeks<br>* Other names: Pitolisant;|
| Experimental: BF2.649 20mg<br> | Drug: BF2.649<br>* 1 capsule per week during 2 weeks<br>* Other names: Pitolisant;|
| Experimental: BF2.649 40mg<br> | Drug: BF2.649<br>* 1 capsule per week during 2 weeks<br>* Other names: Pitolisant;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 capsule per week during 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep disorder, Obstructive Sleep Apnoea, Excessive Daytime Sleepiness