BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP. (HAROSA2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT01072968
First received: February 19, 2010
Last updated: May 15, 2013
Last verified: May 2013

February 19, 2010
May 15, 2013
October 2011
May 2014   (final data collection date for primary outcome measure)
ESS (Epworth Sleepiness Scale) change from baseline [ Time Frame: From baseline to week 12 and week 51 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01072968 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obstructive Sleep Apnea
  • Excessive Daytime Sleepiness
  • Drug: BF2.649
    1 capsule per day in the morning before the breakfast
    Other Name: Pitolisant
  • Drug: Placebo
    1 capsule per day in the morning before the breakfast
    Other Name: placebo
  • Experimental: BF2.649
    BF2.649 capsules dosed at 5 mg, 10 mg, 20 mg
    Intervention: Drug: BF2.649
  • Placebo Comparator: Placebo
    Capsules of placebo containing lactose with low, medium and high dosage
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
268
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with OSA still complaining EDS,refusing nCPAP
  • ESS score ≥ 12

Exclusion Criteria:

  • Patients suffering from insomnia without OSA
  • Co-existing narcolepsy
  • Patient with sleep debt not due to OSA
  • Acute or chronic severe disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01072968
P09-09 / BF2.649
Yes
Bioprojet
Bioprojet
Not Provided
Study Director: Evelyne De Paillette, MD Bioprojet
Bioprojet
May 2013

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