Testing Mexiletine Hydrochloride for Improving Movement in Men with Spinal and Bulbar Muscular Atrophy Randomized, Double-Blind, Placebo-Controlled Phase 23 Study

What this Trial Is About

Researchers are evaluating the effects of mexiletine hydrochloride in men with spinal and bulbar muscular atrophy SBMA, a condition that causes muscle weakness. This clinical trial aims to determine if mexiletine hydrochloride can improve motor function as measured by the ALS Functional Rating Scale-Revised ALSFRS-R score. The study is designed as a randomized, placebo-controlled, double-blind trial to assess both the efficacy and safety of the drug. Participants will be randomly assigned to receive either mexiletine hydrochloride or a placebo. The active treatment involves taking 300 mg of mexiletine hydrochloride orally, divided into three doses after meals each day for 12 weeks. The placebo group will follow the same schedule with an inactive substance. Hospital visits for evaluation will occur every four weeks during the treatment period. During the study, participants will undergo regular assessments including ALSFRS-R scoring at 4 weeks and up to 12 weeks, as well as other tests such as grip strength, tongue pressure, timed walking tests, and respiratory function tests measuring forced vital capacity and peak expiratory flow. These evaluations will help measure motor function and respiratory health. Safety and adherence will be closely monitored throughout the 3-month treatment period.

Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy