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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01071876
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Bioprojet

Tracking Information
First Submitted Date  ICMJE February 18, 2010
First Posted Date  ICMJE February 19, 2010
Last Update Posted Date January 21, 2015
Study Start Date  ICMJE August 2011
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
ESS change (Epworth Sleepiness Scale) [ Time Frame: at week 12 /52 versus baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obstructive Sleep Apnea
  • Excessive Daytime Sleepiness
Intervention  ICMJE
  • Drug: BF2.649
    1 capsule in the morning before breakfast
    Other Name: Pitolisant
  • Drug: Placebo
    1 capsule in the morning before breakfast
Study Arms  ICMJE
  • Experimental: BF2.649
    BF2.649 capsules dosed at 5mg, 10 mg, 20mg
    Intervention: Drug: BF2.649
  • Placebo Comparator: Placebo
    Capsules of Placebo containing lactose with low, medium and high dosage
    Intervention: Drug: Placebo
Publications * Pépin JL, Georgiev O, Tiholov R, Attali V, Verbraecken J, Buyse B, Partinen M, Fietze I, Belev G, Dokic D, Tamisier R, Lévy 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2013)
244
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2010)
280
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01071876
Other Study ID Numbers  ICMJE P09-08 / BF2.649
2009-017248-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bioprojet
Original Responsible Party Dr Jeanne Marie Lecomte / CEO, bioprojet
Current Study Sponsor  ICMJE Bioprojet
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Evelyne De Paillette, MD Bioprojet
PRS Account Bioprojet
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP