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OpenTrials
Completed

NCT Number: NCT01072968

BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Disorders of Excessive Somnolence Dyssomnias Excessive Daytime Sleepiness Mental Disorders Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Universitaire de Grenoble

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with OSA still complaining EDS,refusing nCPAP
  • ESS score ≥ 12

Exclusion criteria

  • Patients suffering from insomnia without OSA
  • Co-existing narcolepsy
  • Patient with sleep debt not due to OSA
  • Acute or chronic severe disease

Treatment and study plan

BF2.649

Drug

1 capsule per day in the morning before the breakfast

Other names: Pitolisant

Placebo

Drug

1 capsule per day in the morning before the breakfast

Primary outcomes

  1. ESS (Epworth Sleepiness Scale) change from baseline

    Time frame: From baseline to week 12 and week 51

Sponsors and collaborators

Lead sponsor

Bioprojet

Other

Registry information

Official study title

Efficacy and Safety of BF2.649 in Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea (OSA) Refusing the Nasal Continuous Positive Airway Pressure (nCPAP) Therapy

Acronym: HAROSA2

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 22, 2010
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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