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

Primary Purpose

Obstructive Sleep Apnea, Excessive Daytime Sleepiness

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
BF2.649
Placebo
Sponsored by
Bioprojet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Sleep disorder, obstructive sleep apnea, excessive daytime sleepiness, patients with OSA treated by CPAP presenting EDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU 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 5mg, 10 mg, 20mg

Capsules of Placebo containing lactose with low, medium and high dosage

Outcomes

Primary Outcome Measures

ESS change (Epworth Sleepiness Scale)

Secondary Outcome Measures

Full Information

First Posted
February 18, 2010
Last Updated
January 20, 2015
Sponsor
Bioprojet
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1. Study Identification

Unique Protocol Identification Number
NCT01071876
Brief Title
BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS
Acronym
HAROSA1
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 Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 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
Sleep disorder, obstructive sleep apnea, excessive daytime sleepiness, patients with OSA treated by CPAP presenting EDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BF2.649
Arm Type
Experimental
Arm Description
BF2.649 capsules dosed at 5mg, 10 mg, 20mg
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 in the morning before breakfast
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule in the morning before breakfast
Primary Outcome Measure Information:
Title
ESS change (Epworth Sleepiness Scale)
Time Frame
at week 12 /52 versus baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
CHU Grenoble
City
Grenoble
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33121980
Citation
Pepin JL, Georgiev O, Tiholov R, Attali V, Verbraecken J, Buyse B, Partinen M, Fietze I, Belev G, Dokic D, Tamisier R, Levy P, Lecomte I, Lecomte JM, Schwartz JC, Dauvilliers Y; HAROSA I Study Group. Pitolisant for Residual Excessive Daytime Sleepiness in OSA Patients Adhering to CPAP: A Randomized Trial. Chest. 2021 Apr;159(4):1598-1609. doi: 10.1016/j.chest.2020.09.281. Epub 2020 Oct 26.
Results Reference
derived

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

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