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

This study has been completed.
Information provided by (Responsible Party):
Bioprojet Identifier:
First received: February 19, 2010
Last updated: January 20, 2015
Last verified: January 2015

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.

Condition Intervention Phase
Obstructive Sleep Apnea
Excessive Daytime Sleepiness
Drug: BF2.649
Drug: Placebo
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Bioprojet:

Primary Outcome Measures:
  • ESS (Epworth Sleepiness Scale) change from baseline [ Time Frame: From baseline to week 12 and week 51 ] [ Designated as safety issue: No ]

Enrollment: 268
Study Start Date: October 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BF2.649
BF2.649 capsules dosed at 5 mg, 10 mg, 20 mg
Drug: BF2.649
1 capsule per day in the morning before the breakfast
Other Name: Pitolisant
Placebo Comparator: Placebo
Capsules of placebo containing lactose with low, medium and high dosage
Drug: Placebo
1 capsule per day in the morning before the breakfast

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01072968

Centre Hospitalier Universitaire de Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
Study Director: Evelyne De Paillette, MD Bioprojet
  More Information

Responsible Party: Bioprojet Identifier: NCT01072968     History of Changes
Other Study ID Numbers: P09-09 / BF2.649 
Study First Received: February 19, 2010
Last Updated: January 20, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
Finland: Finnish Medicines Agency
Bulgaria: Bulgarian Drug Agency
Macedonia: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Bioprojet:
Efficacy and safety study
BF2.649 versus placebo
Patients suffering from Obstructive Sleep Apnea
Complaining from Excessive Daytime Sleepiness
Refusing nasal Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders processed this record on May 23, 2016