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

Obstructive Sleep Apnea Clinical Trial

— HAROSA2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072968
• Other study ID #: P09-09 / BF2.649
• Status: Completed
• Phase: Phase 3
• First received: February 19, 2010
• Last updated: January 20, 2015
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: January 2015
• Source: Bioprojet
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesBelgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Medicines AgencySweden: Medical Products AgencyFinland: Finnish Medicines AgencyBulgaria: Bulgarian Drug AgencyMacedonia: Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal Devices
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Drug:
• BF2.649
1 capsule per day in the morning before the breakfast
• Placebo
1 capsule per day in the morning before the breakfast

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Bioprojet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ESS (Epworth Sleepiness Scale) change from baseline		From baseline to week 12 and week 51	No