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New treatment option for Spinal and Bulbar Muscular Atrophy
Official title Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy
ClinicalTrials.gov ID: NCT06862596
What this study is testing
What is Mexiletine hydrochloride?
Mexiletine hydrochloride is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for spinal and bulbar muscular atrophy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- 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 ≥ 24 and ≤ 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 (However, if the patient is unable to sign...
You likely can't join if
- 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 (myocardial infarction, valvular disease, cardiomyopathy, etc.)
- Patients with sinus bradycardia (\<50 beats/minute)
See the full eligibility criteria
- 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 ≥ 24 and ≤ 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 (However, if the patient is unable to sign the consent form due to the condition of the disease, a person...
- 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 (myocardial infarction, valvular disease, cardiomyopathy, etc.)
- Patients with sinus bradycardia (\<50 beats/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 to sodium channels
- Patients on theophylline
- Patients on narcotics
- Patients who used Mexiletine within 1 month prior to enrollment or used Mexiletine for expectations of improvement in symptoms of SBMA
- Patients with serious complications
- Patients who cannot agree to use contraception during the study period
- Other Patients deemed inappropriate by the investigator or subinvestigator
The study team makes the final eligibility decision.
Where it's taking place
- Bunkyō City, Japan
- Chiba, Japan
- Sapporo, Japan
- Shimotsuke, Japan
- Suita, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bunkyō City, Japan; Chiba, Japan; Sapporo, Japan; Shimotsuke, Japan; Suita, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.