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A 52-Week Phase 3B Randomized Open-Label Study Evaluating the Safety and Pharmacokinetics of Emflaza (Deflazacort) Compared to a Comparable Natural History Control Group in Males Aged ≥2 to <5 Years With Duchenne Muscular Dystrophy (DMD) Followed by a 52-Week Extension Period

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Trial Profile

A 52-Week Phase 3B Randomized Open-Label Study Evaluating the Safety and Pharmacokinetics of Emflaza (Deflazacort) Compared to a Comparable Natural History Control Group in Males Aged ≥2 to <5 Years With Duchenne Muscular Dystrophy (DMD) Followed by a 52-Week Extension Period

Status: Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Deflazacort (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PTCEMF
  • Sponsors PTC Therapeutics

Most Recent Events

  • 15 Jan 2019 Status changed from recruiting to withdrawn prior to enrolment.
  • 28 Nov 2018 Planned End Date changed from 1 Jul 2021 to 31 Jul 2021.
  • 28 Nov 2018 Planned primary completion date changed from 1 Jul 2021 to 31 Jul 2021.

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