Back to resultsBF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP. (HAROSA2)
Primary Purpose
Obstructive Sleep Apnea, Excessive Daytime Sleepiness
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
BF2.649
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring 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
Eligibility 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
Sites / Locations
- Centre Hospitalier Universitaire de Grenoble
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BF2.649
Placebo
Arm Description
BF2.649 capsules dosed at 5 mg, 10 mg, 20 mg
Capsules of placebo containing lactose with low, medium and high dosage
Outcomes
Primary Outcome Measures
ESS (Epworth Sleepiness Scale) change from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01072968
Brief Title
BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.
Acronym
HAROSA2
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 Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioprojet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Excessive Daytime Sleepiness
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
268 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BF2.649
Arm Type
Experimental
Arm Description
BF2.649 capsules dosed at 5 mg, 10 mg, 20 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsules of placebo containing lactose with low, medium and high dosage
Intervention Type
Drug
Intervention Name(s)
BF2.649
Other Intervention Name(s)
Pitolisant
Intervention Description
1 capsule per day in the morning before the breakfast
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule per day in the morning before the breakfast
Primary Outcome Measure Information:
Title
ESS (Epworth Sleepiness Scale) change from baseline
Time Frame
From baseline to week 12 and week 51
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelyne De Paillette, MD
Organizational Affiliation
Bioprojet
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31917607
Citation
Dauvilliers Y, Verbraecken J, Partinen M, Hedner J, Saaresranta T, Georgiev O, Tiholov R, Lecomte I, Tamisier R, Levy P, Scart-Gres C, Lecomte JM, Schwartz JC, Pepin JL; HAROSA II Study Group collaborators. Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial. Am J Respir Crit Care Med. 2020 May 1;201(9):1135-1145. doi: 10.1164/rccm.201907-1284OC. Erratum In: Am J Respir Crit Care Med. 2020 Jul 1;202(1):154-155.
Results Reference
derived
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BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.
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