BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.

Efficacy and Safety of BF2.649 in Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea (OSA) Refusing the Nasal Continuous Positive Airway Pressure (nCPAP) Therapy

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.

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.

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