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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01072968
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : January 21, 2015
Information provided by (Responsible Party):

Brief 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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2011
Primary Completion Date : May 2014
Study Completion Date : May 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. ESS (Epworth Sleepiness Scale) change from baseline [ Time Frame: From baseline to week 12 and week 51 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01072968

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

Responsible Party: Bioprojet Identifier: NCT01072968     History of Changes
Other Study ID Numbers: P09-09 / BF2.649
First Posted: February 22, 2010    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

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
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases