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drugset / Trial / NCT07097701

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

NCT07097701 ↗

Phase 3 Recruiting 24 enrolled Lupin Ltd. Lupin Atlantis Holdings S.A. · collab
RandomizedCrossoverSingle-blindTreatment

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)

Timeline

Start
2025-09-03
Primary completion
2027-01-22
Completion
2027-02-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mexiletine Small molecule 167 mg Oral
Comparator Mexiletine Small molecule 333 mg Oral
Comparator Mexiletine Small molecule 500 mg Oral

Indications

myotonic syndrome