Actively Recruiting
Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy
Led by Masahisa Katsuno · Updated on 2025-04-16
68
Participants Needed
5
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients with a CAG repeat count of 38 or more for the androgen receptor gene in genetic testing and a confirmed diagnosis of SBMA
- Patients with muscle weakness (limb weakness and atrophy, or bulbar palsy) due to lower motor neuron lesion
- Patients with a total ALSFRS-R score of 64 24 and 64 42 at screening
- Patients who are at least 18 years old and less than 80 years old at the time of consent
- Patients who give their voluntary written consent after having received adequate information on this study (or a legal representative provides consent if the patient is unable)
You will not qualify if you...
- Patients who have participated or are participating in a clinical trial within 12 weeks prior to enrollment
- Patients with a history of hypersensitivity to any component of this drug product
- Patients with a conduction disturbance such as second- or third-degree atrioventricular block without a pacemaker, or left bundle branch block
- Patients with Brugada-type ECG
- Patients with severe heart failure or heart disease including myocardial infarction, valvular disease, cardiomyopathy
- Patients with sinus bradycardia (less than 50 beats per minute)
- Patients with systolic blood pressure of 90 mmHg or less
- Patients with serum potassium level less than 3.5 mmol/L
- Patients on antiarrhythmic drugs
- Patients on antiepileptic drugs that affect sodium channels
- Patients on theophylline
- Patients on narcotics
- Patients who used mexiletine within 1 month prior to enrollment or used mexiletine expecting symptom improvement
- Patients with serious complications
- Patients who cannot agree to use contraception during the study period
- Other patients deemed inappropriate by the investigator or subinvestigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Tokyo University Hospital
Bunkyō City, Japan
Actively Recruiting
2
Chiba University Hospital
Chiba, Japan
Actively Recruiting
3
Hokkaido University Hospital
Sapporo, Japan
Actively Recruiting
4
Jichi Medical University Hospital
Shimotsuke, Japan
Actively Recruiting
5
Osaka University Hospital
Suita, Japan
Actively Recruiting
Research Team
M
Masahisa Katsuno, PhD, MD
CONTACT
S
Shinobu Shimizu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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