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Phase 3 Study to Evaluate the Efficacy and Safety of Orally Administered BF2.649 in Japanese Patients with Obstructive Sleep Apnea Syndrome Complaining Excessive Daytime Sleepiness despite Treated by Nasal Continuous Positive Airway Pressure (nCPAP), Consisting of a Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study (Part 1) and Subsequent Open-label Extension Study (Part 2)

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Trial Profile

Phase 3 Study to Evaluate the Efficacy and Safety of Orally Administered BF2.649 in Japanese Patients with Obstructive Sleep Apnea Syndrome Complaining Excessive Daytime Sleepiness despite Treated by Nasal Continuous Positive Airway Pressure (nCPAP), Consisting of a Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study (Part 1) and Subsequent Open-label Extension Study (Part 2)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 25 May 2026

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At a glance

  • Drugs Pitolisant (Primary)
  • Indications Sleep apnoea syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors Aculys Pharma

Most Recent Events

  • 27 Jan 2023 New trial record

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