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Minimum effective dose-finding study of BF2.649, in patients with moderate to severe Obstructive Sleep Apnea, experiencing Excessive Daytime Sleepiness (EDS) despite regular use of nCPAP, and patients having refused this therapy. Randomized, double blind study with BF2.649 (5-, 10-, 20-, 40- mg/d), or placebo.

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Trial Profile

Minimum effective dose-finding study of BF2.649, in patients with moderate to severe Obstructive Sleep Apnea, experiencing Excessive Daytime Sleepiness (EDS) despite regular use of nCPAP, and patients having refused this therapy. Randomized, double blind study with BF2.649 (5-, 10-, 20-, 40- mg/d), or placebo.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Apr 2022

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At a glance

  • Drugs Pitolisant (Primary)
  • Indications Sleep apnoea syndrome
  • Focus Therapeutic Use
  • Sponsors Bioprojet

    • Most Recent Events

    • 13 Jun 2012 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health; NCT01620554).
    • 13 Jun 2012 Lead trial investigator identified as reported by ClinicalTrials.gov.
    • 13 Jun 2012 Actual patient number 110 added as reported by ClincialTrials.gov.
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