Mexiletine granules for prolonged-release oral suspension 333 mg
Sponsors
Lupin Atlantis Holdings SA, Lupin Atlantis Holdings S.A.
Conditions
Myotonic Dystrophy type 1 and type 2 (DM1/DM2)Non-Dystrophic Myotonias (NDM)
Phase 3
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
RecruitingCTIS2024-511179-13-00
Start: 2025-01-13Target: 146Updated: 2025-11-19
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 the MEX-DM-302 Study.
RecruitingCTIS2024-511178-66-00
Start: 2025-09-12Target: 146Updated: 2026-01-22
An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR compared to Mexiletine IR in Patients with Non-Dystrophic Myotonias (ACHILLES study)
RecruitingCTIS2024-514970-27-00
Start: 2025-09-03Target: 20Updated: 2025-09-30