MedTrace Logo

Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy

NCT06862596 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-04-16

No results posted yet for this study

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.

Conditions

  • Spinal and Bulbar Muscular Atrophy

Interventions

DRUG

Mexiletine hydrochloride

Mexiletine hydrochloride 300 mg is administered orally divided into three times a day after meals for 12 weeks.

OTHER

Placebo

Placebo is administered orally divided into three times a day after meals for 12 weeks.

Sponsors & Collaborators

  • Masahisa Katsuno

    lead OTHER

Principal Investigators

  • Masahisa Katsuno, PhD, MD · Nagoya University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06862596 on ClinicalTrials.gov