drugset / Trial / NCT06549400

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.

NCT06549400

Phase 3 Enrolling by invitation 176 enrolled Lupin Ltd. Lupin Atlantis Holdings S.A. · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-09-12
Primary completion
2028-05-29
Completion
2028-07-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Mexiletine Small molecule 500 mg Oral

Indications