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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01620554

Enrollment

110

Registered

2012-06-15

Start date

2010-10-31

Completion date

2011-12-31

Last updated

2012-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnoea, Excessive Daytime Sleepiness

Keywords

Sleep disorder, Obstructive Sleep Apnoea, Excessive Daytime Sleepiness

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.

Interventions

DRUGBF2.649

1 capsule per week during 2 weeks

DRUGPlacebo

1 capsule per week during 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 90 Years

Healthy volunteers

Inclusion criteria

Main inclusion Criteria: * Patient with OSA (treated or not with nCPAP) and still complaining of EDS * Epworth Sleepiness Scale score \> or = to 11 Main

Exclusion criteria

* Patient suffering from chronic severe insomnia in accordance with the International Classification of Sleep Disorders, but without OSA

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026