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.

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

August 18, 2025

Primary Completion Date

May 29, 2028

Study Completion Date

July 6, 2028

Conditions
Myotonic Dystrophy
Interventions
DRUG

Mexiletine granules for prolonged-release oral suspension

Mexiletine PR

All Listed Sponsors
collaborator

Lupin Atlantis Holdings S.A.

UNKNOWN

lead

Lupin Ltd.

INDUSTRY