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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT01620554
First received: June 8, 2012
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Obstructive Sleep Apnoea
Excessive Daytime Sleepiness
Drug: BF2.649
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Bioprojet:

Primary Outcome Measures:
  • Change in Epworth Sleepiness Scale scores (ESS) [ Time Frame: change of ESS at 2 weeks ] [ Designated as safety issue: Yes ]
    ESS value compared from baseline (Day 0) and End of treatment period (Day 14)


Enrollment: 110
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BF2.649 5mg Drug: BF2.649
1 capsule per week during 2 weeks
Other Name: Pitolisant
Experimental: BF2.649 10mg Drug: BF2.649
1 capsule per week during 2 weeks
Other Name: Pitolisant
Experimental: BF2.649 20mg Drug: BF2.649
1 capsule per week during 2 weeks
Other Name: Pitolisant
Experimental: BF2.649 40mg Drug: BF2.649
1 capsule per week during 2 weeks
Other Name: Pitolisant
Placebo Comparator: Placebo Drug: Placebo
1 capsule per week during 2 weeks
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620554

Locations
France
CHU de Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
Bioprojet
Investigators
Study Director: Evelyne De Paillette, MD Bioprojet
  More Information

No publications provided

Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01620554     History of Changes
Other Study ID Numbers: P09-16 / BF2.649, 2010-019413-25
Study First Received: June 8, 2012
Last Updated: June 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Tunisia: Office of Pharmacies and Medicines
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Instituto de Salud Pública de Chile

Keywords provided by Bioprojet:
Sleep disorder
Obstructive Sleep Apnoea
Excessive Daytime Sleepiness

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014