BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS
HAROSA1
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)
2 other identifiers
interventional
244
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 Aug 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 18, 2010
CompletedFirst Posted
Study publicly available on registry
February 19, 2010
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedJanuary 21, 2015
January 1, 2015
2.6 years
February 18, 2010
January 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ESS change (Epworth Sleepiness Scale)
at week 12 /52 versus baseline
Study Arms (2)
BF2.649
EXPERIMENTALBF2.649 capsules dosed at 5mg, 10 mg, 20mg
Placebo
PLACEBO COMPARATORCapsules of Placebo containing lactose with low, medium and high dosage
Interventions
Eligibility Criteria
You may qualify if:
- patients with OSA treated by nCPAP but still complaining with EDS
- ESS score \> or = 12
You may not qualify if:
- patient 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)
CHU Grenoble
Grenoble, 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: 37979718DERIVEDPepin 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.
PMID: 33121980DERIVED
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 18, 2010
First Posted
February 19, 2010
Study Start
August 1, 2011
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
January 21, 2015
Record last verified: 2015-01