The study aims to confirm the effectiveness and safety of BF2.649 by comparing it with a placebo (a pharmacologically inactive product) for the treatment of excessive daytime sleepiness associated with Obstructive Sleep Apnoea treated by nCPAP.

Phase 1

Conditions: Patients with Obstructive Sleep Apnoea syndrome (OSA), and treated by nasal Continuous Positive Airway Pressure (nCPAP), but still complaining of Excessive Daytime Sleepiness (EDS)
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: EUCTR2009-017248-14-BE

Lead Sponsor: BIOPROJET

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 244

Inclusion Criteria

-Male and/or female outpatients of at least 18 years of age
- Patients having been submitted to nCPAP therapy for a minimum period of 3 months and still complaining of Excessive Daytime Sleepiness despite the efforts made beforehand to obtain an efficient nCPAP therapy.
- Polysomnography
- nCPAP = 4 hours / day
- MMS = 28
- BDI-13 items: score < 16 and item G (suicidal ideation) of BDI13 = 0
- BMI <= 40 kg/m²
- Epworth score = 12
- Female patients with child-bearing potential using a medically accepted method of birth control
- If specified by the investigator, patients must be willing not to operate a car or heavy machinery for the duration of the trial
- 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

- Patient suffering from chronic severe insomnia according to International Classification of Sleep Disorders (ICSD 2005) without OSA
- Patient with co-existing narcolepsy (ICSD 2005
- Patient with sleep debt not due to OSA
- Patient with non respiratory sleep fragmentation
- Shift work – Professional drivers
- Refusal from the patient to stop any current therapy for excessive daytime sleepiness, or predictable risks for the patient to stop the therapy
- Patient suffering from a psychiatric disease
- Acute or chronic disease preventing the improvement assessment (severe COPD)
- Current or recent (within one year) history of drugs, alcohol, narcotic, or other substance abuse or dependence
- Any significant serious abnormality of the cardiovascular system
- Severe co-morbid medical, or biological condition that may jeopardize the study participation, at the discretion of the investigator
- Positive serology tests ( HCV – HbsAg and optional HIV)
- Pregnant or breast-feeding women
- Women with child-bearing potential and no efficient birth-control method
- Patient unable to understand the study protocol
- Patient with suspected or known hypersensitivity to study medication
- Patient with a dominant arm deficiency impeding the achievement of the tests
- Patient using a prohibited treatments
- Congenital galactose poisoning, glucose and galactose malabsorption, deficit in lactase
- Patient participating in another study, or being in a follow-up period in 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 period, for the treatment of the excessive diurnal sleepiness in patients with moderate to severe Obstructive Sleep Apnoea (OSA) who experience residual sleepiness despite regular nasal Continuous Positive Airway Pressure (nCPAP) use.;Secondary Objective: The second objective is to assess the long-term tolerance, as well as the maintenance of the efficacy of BF2.649 administered at 5-, 10-, or 20 mg once a day during 40 weeks.;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: TMT PARTS A&B<br>? CGI Assessment of illness severity and Improvement<br>? The Pichot Fatigue scale;Timepoint(s) of evaluation of this end point: see protocol

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