NCT01072968

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: Bioprojet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea
• Excessive Daytime Sleepiness

Interventions

Type	Name	Description
DRUG	BF2.649	1 capsule per day in the morning before the breakfast
DRUG	Placebo	1 capsule per day in the morning before the breakfast

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2010-02-22
• Last updated: 2015-01-21

Locations

1 site across 1 country: France