Excessive diurnal sleepiness in patients with moderate to severe Obstructive Sleep Apnoea (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy MedDRA version: 14.1 Level: LLT Classification code 10015595 Term: Excessive daytime sleepiness System Organ Class: 100000004852
Conditions
Interventions
Product Name: Pitolisant
Product Code: BF2.649
Pharmaceutical Form: Capsule
INN or Proposed INN: Pitolisant
Current Sponsor code: BF2.649
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Bioprojet
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
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 already known or diagnosed during the trial. The necessary examinations have to be carried out at each visit. • 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 ? Persons that have been placed in an institution due to official or judicial order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): ?Percentage of Epworth responders ? Reduction of sleepiness and sleep episodes on the sleep diary ? Improvement in vigilance on the modified maintenance of wakefulness Test ? Increase in Quality of life ? Improvement in cognitive function ? Improvement in CGI Assessment of illness severity;Timepoint(s) of evaluation of this end point: see protocol | — |
Countries
Bulgaria, Denmark, Finland, Germany, Spain, Sweden
Outcome results
None listed