Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)
- Conditions
- Obstructive Sleep ApnoeaExcessive Daytime Sleepiness
- Interventions
- Drug: Placebo
- Registration Number
- NCT01620554
- Lead Sponsor
- Bioprojet
- Brief Summary
Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BF2.649 5mg BF2.649 - Placebo Placebo - BF2.649 20mg BF2.649 - BF2.649 40mg BF2.649 - BF2.649 10mg BF2.649 -
- Primary Outcome Measures
Name Time Method Change in Epworth Sleepiness Scale scores (ESS) change of ESS at 2 weeks ESS value compared from baseline (Day 0) and End of treatment period (Day 14)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU de Grenoble
🇫🇷Grenoble, France