- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01072968
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
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.
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Grenoble, France, 38043
- Centre Hospitalier Universitaire de Grenoble
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BF2.649
BF2.649 capsules dosed at 5 mg, 10 mg, 20 mg
|
1 capsule per day in the morning before the breakfast
Other Names:
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Placebo Comparator: Placebo
Capsules of placebo containing lactose with low, medium and high dosage
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1 capsule per day in the morning before the breakfast
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ESS (Epworth Sleepiness Scale) change from baseline
Time Frame: From baseline to week 12 and week 51
|
From baseline to week 12 and week 51
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Evelyne De Paillette, MD, Bioprojet
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P09-09 / BF2.649
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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