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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bioprojet

ClinicalTrials.gov Identifier:

NCT01072968

First received: February 19, 2010

Last updated: January 20, 2015

Last verified: January 2015

History of Changes

Purpose

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:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 ClinicalTrials.gov identifier: NCT01072968

Locations


France
Centre Hospitalier Universitaire de Grenoble
Grenoble, France, 38043

Sponsors and Collaborators

Bioprojet

Investigators


Study Director:	Evelyne De Paillette, MD	Bioprojet

More Information


Responsible Party:	Bioprojet
ClinicalTrials.gov 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:


Multicenter Randomized Double-blind 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:


Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory	Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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