Obstructive Sleep Apnea, Excessive Daytime Sleepiness
Conditions
Keywords
Multicenter, Randomized, Double-blind, Efficacy and safety study, BF2.649 versus placebo, Patients suffering from Obstructive Sleep Apnea, Complaining from Excessive Daytime Sleepiness, Refusing nasal Continuous Positive Airway Pressure
Brief summary
Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose. This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.
Detailed description
The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo. The aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy.
Interventions
DRUGBF2.649
1 capsule per day in the morning before the breakfast
DRUGPlacebo
1 capsule per day in the morning before the breakfast
Sponsors
Bioprojet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with OSA still complaining EDS,refusing nCPAP * ESS score ≥ 12
Exclusion criteria
* Patients suffering from insomnia without OSA * Co-existing narcolepsy * Patient with sleep debt not due to OSA * Acute or chronic severe disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ESS (Epworth Sleepiness Scale) change from baseline | From baseline to week 12 and week 51 |
Countries
France
Outcome results
None listed