A Phase 2 interventional study of BF2.649 and BF2.649 in Obstructive Sleep Apnoea and Excessive Daytime Sleepiness, sponsored by Bioprojet. Completed at 1 site in France. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-06-15.
Sponsored by Bioprojet · Phase 2, Interventional, and Treatment
Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).
Obstructive sleep apnea (OSA) is a relatively common condition and is estimated to affect 2 to 4% of middle-aged adults
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 110 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Bioprojet is the lead sponsor of 28 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main inclusion Criteria:
Main exclusion Criteria:
Drug: BF2.649
Drug: BF2.649
Drug: BF2.649
Drug: BF2.649
Drug: Placebo
1 capsule per week during 2 weeks
Also known as: Pitolisant
1 capsule per week during 2 weeks
Also known as: Pitolisant
1 capsule per week during 2 weeks
Also known as: Pitolisant
1 capsule per week during 2 weeks
Also known as: Pitolisant
1 capsule per week during 2 weeks
Change in Epworth Sleepiness Scale scores (ESS)
ESS value compared from baseline (Day 0) and End of treatment period (Day 14)
Time frame: change of ESS at 2 weeks
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Bioprojet