drugset / Trial / NCT06862596

Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy

NCT06862596

Phase 2/3 Recruiting 68 enrolled Masahisa Katsuno
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this clinical trial is to evaluate the efficacy and safety of mexiletine hydrochloride in patients with spinal and bulbar muscular atrophy. The main questions it aims to answer are: Does mexiletine hydrochloride improve the ALSFRS-R score in spinal and bulbar muscular atrophy patients? Participants will: Take mexiletine hydrochloride or a placebo every day for 3 months Visit the hospital once every 4 weeks for evaluations.

Timeline

Start
2025-02-28
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mexiletine Small molecule 300 mg Oral