- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01071876
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)
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
-
-
-
Grenoble, France
- CHU Grenoble
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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 5mg, 10 mg, 20mg
|
1 capsule in the morning before breakfast
Other Names:
|
Placebo Comparator: Placebo
Capsules of Placebo containing lactose with low, medium and high dosage
|
1 capsule in the morning before breakfast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ESS change (Epworth Sleepiness Scale)
Time Frame: at week 12 /52 versus baseline
|
at week 12 /52 versus baseline
|
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
- P09-08 / BF2.649
- 2009-017248-14 (EudraCT Number)
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.
Clinical Trials on Obstructive Sleep Apnea
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
ResMedCompletedObstructive Sleep Apnea (OSA)United States, Australia
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States