Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated February 6, 2026 (before its estimated March 17, 2026 completion). Its status may not reflect the trial's current state.
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)
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-07-23; most recent amendment 2026-02-05.
Status change: Not Yet Recruiting → Recruiting 2025-08-21
Trial Details
NCT Number NCT06523400
Lead Sponsor Lupin Ltd.
Collaborators: Lupin Atlantis Holdings S.A.
Conditions Myotonic Dystrophy
Enrollment 176 participants
Start Date 2025-02-13
Primary Completion 2026-03-17 (estimated)
Study Completion 2026-04-22 (estimated)
Updated on ClinicalTrials.gov 2026-02-06