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OpenTrials
Completed

NCT Number: NCT01071876

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

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 Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms 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

CHU Grenoble

Grenoble, 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 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

Treatment and study plan

BF2.649

Drug

1 capsule in the morning before breakfast

Other names: Pitolisant

Placebo

Drug

1 capsule in the morning before breakfast

Primary outcomes

  1. ESS change (Epworth Sleepiness Scale)

    Time frame: at week 12 /52 versus baseline

Sponsors and collaborators

Lead sponsor

Bioprojet

Other

Registry information

Official study 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)

Acronym: HAROSA1

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 19, 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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