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BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS (HAROSA1)

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ClinicalTrials.gov Identifier: NCT01071876
Recruitment Status : Completed
First Posted : February 19, 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 : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : August 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Experimental: BF2.649
BF2.649 capsules dosed at 5mg, 10 mg, 20mg
 Drug: BF2.649
1 capsule in the morning before breakfast
Other Name: Pitolisant
Placebo Comparator: Placebo
Capsules of Placebo containing lactose with low, medium and high dosage
 Drug: Placebo
1 capsule in the morning before breakfast


Outcome Measures
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Primary Outcome Measures :
  1. ESS change (Epworth Sleepiness Scale) [ Time Frame: at week 12 /52 versus baseline ]

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 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
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): NCT01071876


Locations
France
CHU Grenoble
Grenoble, France
Sponsors and Collaborators
Bioprojet
Investigators
Study Director: Evelyne De Paillette, MD Bioprojet
More Information
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Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01071876     History of Changes
Other Study ID Numbers: P09-08 / BF2.649
2009-017248-14 ( EudraCT Number )
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Bioprojet:
Sleep disorder
obstructive sleep apnea
excessive daytime sleepiness
patients with OSA treated by CPAP presenting EDS

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