Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)
NCT ID: NCT01620554
Last Updated: 2012-06-15
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2010-10-31
2011-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.
NCT01072968
BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS
NCT01071876
Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness
NCT02978651
Comprehensive Management for the Treatment of Obstructive Sleep Apnea
NCT02482480
Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.
NCT01918449
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study medication BF2.649 tested here is a novel, highly potent, selective, orally active inverse agonist at the histamine H3 receptor, therefore strengthens histaminergic transmission in the brain and increases wakefulness EDS is characterized by daytime somnolence and sudden sleep episodes. This problem has several consequences, e.g., an impairment of quality of life, an interference with activities of daily living and other handicaps in the management of social and family affairs.
The primary endpoint of this study will be measured by the change in the well-validated Epworth sleepiness scale (ESS). The ESS is a simple self-administered 8-item questionnaire. The outcome is to get an impression about the level of the daytime sleepiness in several real-life situations.
In this study, each patient will be treated during 2 weeks, and randomly assigned to one the 5 arms (BF2.649 at one of the 4 possible dosages or placebo).
The patient will then attend a end-of-treatment visit, in order to assess the particularly the ESS score.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BF2.649 5mg
BF2.649
1 capsule per week during 2 weeks
BF2.649 10mg
BF2.649
1 capsule per week during 2 weeks
BF2.649 20mg
BF2.649
1 capsule per week during 2 weeks
BF2.649 40mg
BF2.649
1 capsule per week during 2 weeks
Placebo
Placebo
1 capsule per week during 2 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BF2.649
1 capsule per week during 2 weeks
BF2.649
1 capsule per week during 2 weeks
BF2.649
1 capsule per week during 2 weeks
BF2.649
1 capsule per week during 2 weeks
Placebo
1 capsule per week during 2 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Epworth Sleepiness Scale score \> or = to 11
Exclusion Criteria
21 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bioprojet
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Evelyne De Paillette, MD
Role: STUDY_DIRECTOR
Bioprojet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Grenoble
Grenoble, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-019413-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P09-16 / BF2.649
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.