Overview

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.

Status:
NOT_YET_RECRUITING

Trial end date:
2028-07-06

Target enrollment:

Participant gender:

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.

Phase:

PHASE3

Details

Lead Sponsor:

Lupin Ltd.

Collaborator:

Lupin Atlantis Holdings S.A.