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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 MEX-DM-302 Study.

NCT06549400 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2026-01-26

No results posted yet for this study

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.

Conditions

  • Myotonic Dystrophy

Interventions

DRUG

Mexiletine granules for prolonged-release oral suspension

Mexiletine PR

Sponsors & Collaborators

  • Lupin Atlantis Holdings S.A.

    collaborator UNKNOWN

  • Lupin Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Belgium
  • Denmark
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06549400 on ClinicalTrials.gov