BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS (HAROSA1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT01071876
First received: February 18, 2010
Last updated: May 15, 2013
Last verified: January 2013
  Purpose

Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose.

This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.


Condition Intervention Phase
Obstructive Sleep Apnea
Excessive Daytime Sleepiness
Drug: BF2.649
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BF2.649 in Patients With Obstructive Sleep Apnea Syndrome (OSA) and Treated by Nasal Continuous Positive Airway Pressure (nCPAP), But Still Complaining of Excessive Daytime Sleepiness (EDS)

Resource links provided by NLM:


Further study details as provided by Bioprojet:

Primary Outcome Measures:
  • ESS change (Epworth Sleepiness Scale) [ Time Frame: at week 12 /52 versus baseline ] [ Designated as safety issue: No ]

Enrollment: 244
Study Start Date: August 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BF2.649
BF2.649 capsules dosed at 5mg, 10 mg, 20mg
Drug: BF2.649
1 capsule in the morning before breakfast
Other Name: Pitolisant
Placebo Comparator: Placebo
Capsules of Placebo containing lactose with low, medium and high dosage
Drug: Placebo
1 capsule in the morning before breakfast

Detailed Description:

The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo.

The aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with OSA treated by nCPAP but still complaining with EDS
  • ESS score > or = 12

Exclusion Criteria:

  • patient suffering from insomnia without OSA
  • co-existing narcolepsy
  • patient with sleep debt not due to OSA
  • acute or chronic severe disease
  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: NCT01071876

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

No publications provided

Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01071876     History of Changes
Other Study ID Numbers: P09-08 / BF2.649, 2009-017248-14
Study First Received: February 18, 2010
Last Updated: May 15, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
Finland: Finnish Medicines Agency
Bulgaria: Bulgarian Drug Agency
Macedonia: Ministry of Health

Keywords provided by Bioprojet:
Sleep disorder
obstructive sleep apnea
excessive daytime sleepiness
patients with OSA treated by CPAP presenting EDS

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 August 26, 2014