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

June 13, 2012 updated by: Bioprojet

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU de Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
1 capsule per week during 2 weeks
Experimental: BF2.649 5mg
Drug: BF2.649
1 capsule per week during 2 weeks
Other Names:
  • Pitolisant
Experimental: BF2.649 10mg
Drug: BF2.649
1 capsule per week during 2 weeks
Other Names:
  • Pitolisant
Experimental: BF2.649 20mg
Drug: BF2.649
1 capsule per week during 2 weeks
Other Names:
  • Pitolisant
Experimental: BF2.649 40mg
Drug: BF2.649
1 capsule per week during 2 weeks
Other Names:
  • Pitolisant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Epworth Sleepiness Scale scores (ESS)
Time Frame: change of ESS at 2 weeks
ESS value compared from baseline (Day 0) and End of treatment period (Day 14)
change of ESS at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioprojet

Investigators

  • Study Director: Evelyne De Paillette, MD, Bioprojet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 8, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (Estimate)

June 15, 2012

Study Record Updates

Last Update Posted (Estimate)

June 15, 2012

Last Update Submitted That Met QC Criteria

June 13, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P09-16 / BF2.649
  • 2010-019413-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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