BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP. — HAROSA2  

Obstructive Sleep Apnea Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Excessive Daytime Sleepiness
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT01072968
• Study type: Interventional
• Source: Bioprojet
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Completion date: May 2014