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The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2

NCT06523400 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2026-02-06

No results posted yet for this study

Summary

A Randomized, Double-blind, Placebo-Controlled, Multi-Center Study to Investigate the Efficacy and Safety of Once Daily Mexiletine PR During 26 Weeks of Treatment in Patients with Myotonic Dystrophy Type 1 and Type 2 (HERCULES study)

Conditions

  • Myotonic Dystrophy

Interventions

DRUG

Mexiletine granules for prolonged-release oral suspension

Mexiletine PR

DRUG

Placebo

Matching Placebo

Sponsors & Collaborators

  • Lupin Atlantis Holdings S.A.

    collaborator UNKNOWN

  • Lupin Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-13
Primary Completion
2026-03-17
Completion
2026-04-22

Countries

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

Study Locations

More Related Trials

Entities

Drugs

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 NCT06523400 on ClinicalTrials.gov