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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioprojet

Criteria

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