Clinical Trial

An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR

Recruiting Phase 3
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Summary
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)
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-07-24; most recent amendment 2025-12-15.
Status change: Not Yet Recruiting → Recruiting 2025-09-22
Trial Details
NCT Number NCT07097701
Lead Sponsor Lupin Ltd.
Collaborators: Lupin Atlantis Holdings S.A.
Conditions Myotonia
Enrollment 24 participants
Start Date 2025-09-03
Primary Completion 2027-01-22 (estimated)
Study Completion 2027-02-22 (estimated)
Updated on ClinicalTrials.gov 2025-12-22