Clinical Trial

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 MEX-DM-302 Study.

Enrolling by Invitation Phase 3
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Summary
This is an open-label extension study intended to evaluate the long-term safety and efficacy of mexiletine PR in patients with myotonic dystrophy type 1 and type 2 (DM1 and DM2) who have completed the parent study MEX-DM-302.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-08-09; most recent amendment 2026-01-23.
Status change: Not Yet Recruiting → Enrolling by Invitation 2026-01-21
Trial Details
NCT Number NCT06549400
Lead Sponsor Lupin Ltd.
Collaborators: Lupin Atlantis Holdings S.A.
Conditions Myotonic Dystrophy
Enrollment 176 participants
Start Date 2025-09-12
Primary Completion 2028-05-29 (estimated)
Study Completion 2028-07-06 (estimated)
Updated on ClinicalTrials.gov 2026-01-26