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

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ClinicalTrials.gov Identifier: NCT01072968
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Bioprojet

Study Description
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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 Design
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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
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Bioprojet
ClinicalTrials.gov 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:
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