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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1, Followed by an Open-Label Extension

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1, Followed by an Open-Label Extension

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Apr 2025

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At a glance

  • Drugs Pitolisant (Primary)
  • Indications Myotonic dystrophy; Narcolepsy
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Harmony Biosciences

Most Recent Events

  • 25 Apr 2025 Status changed from active, no longer recruiting to completed.
  • 05 Jun 2024 According to a Harmony Biosciences media release, data from this study presented at the annual meeting of the Associated Professional Sleep Societies, "SLEEP 2024"
  • 05 Jun 2024 Results published in the Harmony Biosciences Media Release

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