BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS

Obstructive Sleep Apnea Clinical Trial

— HAROSA1  

Official title:

BF2.649 in Patients With Obstructive Sleep Apnea Syndrome (OSA) and Treated by Nasal Continuous Positive Airway Pressure (nCPAP), But Still Complaining of Excessive Daytime Sleepiness (EDS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071876
• Other study ID #: P09-08 / BF2.649
• Secondary ID: 2009-017248-14
• Status: Completed
• Phase: Phase 3
• First received: February 18, 2010
• Last updated: January 20, 2015
• Start date: August 2011
• Est. completion date: March 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 Health
• 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: 244
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with OSA treated by nCPAP but still complaining with EDS

• ESS score > or = 12

Exclusion Criteria:

• patient 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 in the morning before breakfast
• Placebo
1 capsule in the morning before breakfast

Locations

Country	Name	City	State
France	CHU 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 change (Epworth Sleepiness Scale)		at week 12 /52 versus baseline	No