Efficacy and safety of BF2.649 in the treatment of Excessive Daytime Sleepiness in patients with Obstructive Sleep Apnoea syndrome (OSA), refusing the nasal continuous positive airway pressure (nCPAP) therapy - HAROSA II

• 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: 12.1Level: LLTClassification code 10015595Term: Excessive daytime sleepiness

• Registration Number: EUCTR2009-017251-94-FI
• Lead Sponsor: Bioprojet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-29
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Male and/or female outpatients aged from at least 18 years of age
? Polysomnography (a description of full night polysomnography is detailed in appendix 3) performed between V1 and V2 or during the last twelve months with:. Apnoea-Hypopnoea Index (AHI) ? 15
Periodic Limb Movement Disorders as defined by by PLM Arousal Index (PLMAI) ? 10
? 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 (an example of MMSE14 questionnaire is provided in Appendix 9)
? Body Mass Index (BMI) ? 40 Kg/m2
? Female patients with child-bearing potential using a medically accepted method of birth control, (i.e. oral contraceptives of normal average dosage) agreeing to continue this method throughout the study, and during the month following treatment discontinuation, being negative to the serum pregnancy test performed at the screening visit
? 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Patient without OSA, suffering from chronic severe insomnia in accordance with the International Classification of Sleep Disorders (ICSD 2005) without OSA.
? Patient with co-existing narcolepsy (ICSD 2005), judged on clinical criteria
? Patient with sleep debt not due to OSA (according to physician?s judgment)
? Patient with non respiratory sleep fragmentation (restless legs syndrome…)
? 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 that could bother the appreciation of improvement in EDS (i.e. COPD…)
? Current or recent (within one year) history of drug, alcohol, narcotic or other substance or dependence.
? Patient with a dominant arm deficiency impeding the achievement of the tests
? Any significant serious abnormality of the cardiovascular system, e.g. recent myocardial infarction, angina, hypertension or dysrhythmias (within the previous 6 months), Electrocardiogram Bazett?s corrected QT interval higher than 450 ms, history of left ventricular hypertrophy or mitral valve prolapse
? Severe co-morbid medical or biological conditions that may jeopardize the study participation, at the discretion of the investigator ( particularly, in the cardiovascular system and instable diabetes)
? Positive serology tests (optional HIV–HCV–HBsAg)
? 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 hypersensibility to study medication
? Patient with a dominant arm deficiency impeding the achievement of the test
? Patient using prohibited treatments
? Patient participating to another study, or being in a follow-up period in another study
Congenital galactose poisoining, glucose and galactose malabsorption, deficit in
lactase

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified