NCT01620554

Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)

Minimum Effective Dose-Finding Study of BF2.649, in Patients With Moderate to Severe OSA, Experiencing EDS Despite Regular Use of nCPAP, and Patients Having Refused This Therapy - Randomized, Double Blind Study With BF2.649 or Placebo

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Bioprojet · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnoea
• Excessive Daytime Sleepiness

Interventions

Type	Name	Description
DRUG	BF2.649	1 capsule per week during 2 weeks
DRUG	BF2.649	1 capsule per week during 2 weeks
DRUG	BF2.649	1 capsule per week during 2 weeks
DRUG	BF2.649	1 capsule per week during 2 weeks
DRUG	Placebo	1 capsule per week during 2 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2012-06-15
• Last updated: 2012-06-15

Locations

1 site across 1 country: France