NCT06862596 Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy
| NCT ID | NCT06862596 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Masahisa Katsuno |
| Condition | Spinal and Bulbar Muscular Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-02-28 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 68 participants in total. It began in 2025-02-28 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. 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 2. Patients with muscle weakness (limb weakness and atrophy, or bulbar palsy) due to lower motor neuron lesion 3. Patients with a total ALSFRS-R score of ≥ 24 and ≤ 42 at screening 4. Patients who are at least 18 years old and less than 80 years old at the time of consent 5. Patients who give their voluntary written consent after having received adequate information on this study (However, if the patient is unable to sign the consent form due to the condition of the disease, a person equivalent to a regal representative must be present to provide written explanation, the prospective candidate must verbally consent to participate in the study, and a person equivalent to a regal representative must sign the consent form on behalf of the patient. The person who is to be the regal representative may sign the document on his/her behalf, noting the circumstances and his/her relationship to the subject.) Exclusion Criteria: 1. Patients who have participated or are participating in a clinical trial within 12 weeks prior to enrollment 2. Patients with a history of hypersensitivity to any component of this drug product 3. Patients with a conduction disturbance (such as second- or third-degree atrioventricular block without a pacemaker, or left bundle branch block) 4. Patients with Brugada-type ECG 5. Patients with severe heart failure or heart disease (myocardial infarction, valvular disease, cardiomyopathy, etc.) 6. Patients with sinus bradycardia (\<50 beats/minute) 7. Patients with systolic blood pressure of 90 mmHg or less 8. Patients with serum potassium level less than 3.5 mmol/L 9. Patients on antiarrhythmic drugs 10. Patients on antiepileptic drugs that affect to sodium channels 11. Patients on theophylline 12. Patients on narcotics 13. Patients who used Mexiletine within 1 month prior to enrollment or used Mexiletine for expectations of improvement in symptoms of SBMA 14. Patients with serious complications 15. Patients who cannot agree to use contraception during the study period 16. Other Patients deemed inappropriate by the investigator or subinvestigator
Contact & Investigator
Masahisa Katsuno, PhD, MD
PRINCIPAL INVESTIGATOR
Nagoya University Hospital
Frequently Asked Questions
Who can join the NCT06862596 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Spinal and Bulbar Muscular Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06862596 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06862596 currently recruiting?
Yes, NCT06862596 is actively recruiting participants. Contact the research team at katsuno.masahisa.i1@f.mail.nagoya-u.ac.jp for enrollment information.
Where is the NCT06862596 trial being conducted?
This trial is being conducted at Bunkyō City, Japan, Chiba, Japan, Sapporo, Japan, Shimotsuke, Japan and 1 additional location.
Who is sponsoring the NCT06862596 clinical trial?
NCT06862596 is sponsored by Masahisa Katsuno. The principal investigator is Masahisa Katsuno, PhD, MD at Nagoya University Hospital. The trial plans to enroll 68 participants.