BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS
NCT ID: NCT01071876
Last Updated: 2015-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
244 participants
INTERVENTIONAL
2011-08-31
2014-03-31
Brief Summary
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This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BF2.649
BF2.649 capsules dosed at 5mg, 10 mg, 20mg
BF2.649
1 capsule in the morning before breakfast
Placebo
Capsules of Placebo containing lactose with low, medium and high dosage
Placebo
1 capsule in the morning before breakfast
Interventions
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BF2.649
1 capsule in the morning before breakfast
Placebo
1 capsule in the morning before breakfast
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ESS score \> or = 12
Exclusion Criteria
* co-existing narcolepsy
* patient with sleep debt not due to OSA
* acute or chronic severe disease
18 Years
ALL
No
Sponsors
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Bioprojet
OTHER
Responsible Party
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Principal Investigators
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Evelyne De Paillette, MD
Role: STUDY_DIRECTOR
Bioprojet
Locations
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CHU Grenoble
Grenoble, , France
Countries
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References
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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.
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.
Other Identifiers
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2009-017248-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P09-08 / BF2.649
Identifier Type: -
Identifier Source: org_study_id
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