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An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 Who Have Completed the MEX-DM-302 Study (ATLAS Study)

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Trial Profile

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 Who Have Completed the MEX-DM-302 Study (ATLAS Study)

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2025

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At a glance

  • Drugs Mexiletine (Primary)
  • Indications Myotonic dystrophy
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ATLAS Study
  • Sponsors Lupin

Most Recent Events

  • 03 Aug 2025 Planned End Date changed from 22 Jun 2027 to 6 Jul 2028.
  • 03 Aug 2025 Planned primary completion date changed from 17 Apr 2027 to 29 May 2028.
  • 03 Aug 2025 Planned initiation date changed from 27 Feb 2025 to 18 Aug 2025.

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