The study aims to confirm the effectiveness and safety of BF2.649 over placebo for the treatment of excessive daytime sleepiness associated with Obstructive Sleep Apnoea syndrome in patients who refuse CPAP therapy

Phase 1

Conditions: Excessive diurnal sleepiness in patients with moderate to severe Obstructive Sleep Apnoea (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy
MedDRA version: 13.1Level: LLTClassification code 10015595Term: Excessive daytime sleepinessSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2009-017251-94-BE

Lead Sponsor: Bioprojet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 268

Inclusion Criteria

-Male and/or female outpatients aged from at least 18 years of age
-Polysomnography
-Patients refusing to be treated by nCPAP therapy, and still complaining of Excessive Daytime Sleepiness
-Epworth Sleepiness scale = 12
-Beck Depression Inventory 13 items (BDI-13 items): score < 16 and item G = 0
-Mini Mental State Examination (MMSE) ? 28
-Body Mass Index (BMI) ? 40 Kg/m2
-Female patients with child-bearing potential using a medically accepted method of birth control
-If specified by the investigator, the patient must be willing not to operate a car (if sleepy at wheel) or heavy machinery for the duration of the trial, or as long as the investigator deems it clinically indicated. In addition, patients should be willing to maintain during the study their usual behaviours which could affect their diurnal sleepiness (e.g. circadian rhythm, caffeine consumption, nocturnal sleep duration).
-Patients having signed and dated the informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

•Patients suffering from chronic severe insomnia in accordance with the International Classification of Sleep Disorders (ICSD 2005) without OSA
•Patients with co-existing narcolepsy (ICSD 2005)
•Patients with sleep debt not due to OSA
•Patients with non-respiratory sleep fragmentation
•Shift work - professional drivers
•Refusal from the patient to stop any current therapy for excessive daytime sleepiness or predictable risk for the patient to stop the therapy
•Patients suffering from a psychiatric disease
•Acute or chronic disease preventing the improvement assessment
•Current or recent (within one year) history of drug, alcohol, narcotic or other substance abuse or dependence.
•Any significant serious abnormality of the cardiovascular system
•Severe comorbid medical and biological conditions that may jeopardize study participation at the discretion of the investigator.
•Positive serological test (optional HIV, HCV and HBsAg)
•Pregnant or breast-feeding women
•Women with child-bearing potential and no efficient birth-control method
•Patients unable to understand the study protocol
•Patients with suspected or known hypersensitivity to study medication
•Patients with a dominant arm deficiency impeding the achievement of the tests
•Patients using a prohibited medication
•Congenital galactose poisoning, glucose and galactose malabsorption, deficit in lactase
•Patients participating in another study or being in a follow–up period for another study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The first objective of this study is to demonstrate the efficacy and safety of BF2.649 given at 5, 10, or 20 mg per day versus placebo during 12 weeks for the double blind phase, to treat the excessive diurnal sleepiness in patients with moderate to severe Obstructive Sleep Apnoea (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy.;Secondary Objective: The second objective of the open label extension phase is to assess the long-term tolerance as well as the maintenance of efficacy of the BF2.649 received by these patients.;Primary end point(s): Change of the score of the Epworth Scale difference between the baseline (Mean between V1 and V2) and the end of the double-blind period (Mean between V5 and V6);Timepoint(s) of evaluation of this end point: see protocol

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ?Percentage of Epworth responders <br>? Reduction of sleepiness and sleep episodes on the sleep diary <br>? Improvement in vigilance on the modified maintenance of wakefulness Test <br>? Increase in Quality of life <br>? Improvement in cognitive function<br>? Improvement in CGI Assessment of illness severity;Timepoint(s) of evaluation of this end point: see protocol

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