Phase 3 Spinal Muscular Atrophy Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are a male with a confirmed diagnosis of SBMA (Spinal and Bulbar Muscular Atrophy), confirmed by genetic testing showing a specific gene repeat count of 38 or more
- You have muscle weakness in your arms or legs, muscle wasting, or weakness in the muscles used for swallowing or speaking, caused by damage to the lower motor nerves
- Your overall physical function score (measured by a standard scale called ALSFRS-R) falls within a specific range — between 24 and 42 — at the time of screening
- You are aged 18 or older but under 80 years old at the time of giving consent
- You are willing and able to give written consent to take part in the study (if you are unable to sign due to your condition, a legal representative may sign on your behalf with your verbal agreement)
Who may not be able to join:
- You have taken part in, or are currently taking part in, another clinical trial within the past 12 weeks
- You have had an allergic reaction to any ingredient in the study drug
- You have certain heart rhythm conduction problems, such as second- or third-degree heart block without a pacemaker, or a specific electrical pattern in the heart called left bundle branch block
- You have a specific heart rhythm pattern on an ECG known as Brugada-type pattern
- You have severe heart failure or serious heart conditions such as a previous heart attack, heart valve disease, or disease of the heart muscle
- Your resting heart rate is slower than 50 beats per minute
- Your systolic (upper number) blood pressure is 90 mmHg or below
- Your blood potassium level is below 3.5 mmol/L
- You are currently taking medicines to control heart rhythm (antiarrhythmic drugs)
- You are currently taking certain epilepsy medicines that affect sodium channels in the body (confirm with trial site)
- You are currently taking a medicine called theophylline (often used for breathing conditions)
- You are currently taking narcotic (opioid) medicines
- You have used a medicine called Mexiletine within the past month, or have used it specifically to try to manage SBMA symptoms
- You have other serious health complications (confirm with trial site for specifics)
- You are unwilling or unable to use contraception throughout the study period
- The trial doctor considers you unsuitable for any other reason
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Masahisa Katsuno, PhD, MD, Nagoya University Hospital
Phone: +81527442389
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.