BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.
HAROSA2
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
1 other identifier
interventional
268
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2010
CompletedFirst Posted
Study publicly available on registry
February 22, 2010
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJanuary 21, 2015
January 1, 2015
2.6 years
February 19, 2010
January 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ESS (Epworth Sleepiness Scale) change from baseline
From baseline to week 12 and week 51
Study Arms (2)
BF2.649
EXPERIMENTALBF2.649 capsules dosed at 5 mg, 10 mg, 20 mg
Placebo
PLACEBO COMPARATORCapsules of placebo containing lactose with low, medium and high dosage
Interventions
Eligibility Criteria
You may qualify if:
- Patients with OSA still complaining EDS,refusing nCPAP
- ESS score ≥ 12
You may not qualify if:
- Patients suffering from insomnia without OSA
- Co-existing narcolepsy
- Patient with sleep debt not due to OSA
- Acute or chronic severe disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bioprojetlead
Study Sites (1)
Centre Hospitalier Universitaire de Grenoble
Grenoble, Grenoble, 38043, France
Related Publications (2)
Pepin JL, Attali V, Causse C, Verbraecken J, Hedner J, Lecomte I, Tamisier R, Levy P, Lehert P, Dauvilliers Y. Long-Term Efficacy and Safety of Pitolisant for Residual Sleepiness Due to OSA. Chest. 2024 Mar;165(3):692-703. doi: 10.1016/j.chest.2023.11.017. Epub 2023 Nov 17.
PMID: 37979718DERIVEDDauvilliers 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.
PMID: 31917607DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Evelyne De Paillette, MD
Bioprojet
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2010
First Posted
February 22, 2010
Study Start
October 1, 2011
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
January 21, 2015
Record last verified: 2015-01