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

Obstructive Sleep Apnoea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620554
• Other study ID #: P09-16 / BF2.649
• Secondary ID: 2010-019413-25
• Status: Completed
• Phase: Phase 2
• First received: June 8, 2012
• Last updated: June 13, 2012
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: Bioprojet
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Tunisia: Office of Pharmacies and MedicinesArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaChile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial Summary

Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).

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 information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Excessive Daytime Sleepiness
• Obstructive Sleep Apnoea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	CHU de Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Bioprojet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Epworth Sleepiness Scale scores (ESS)	ESS value compared from baseline (Day 0) and End of treatment period (Day 14)	change of ESS at 2 weeks	Yes