The primary study objective is to determine whether treatment with mexiletine at doses of 300 mg/day or 600 mg/day suppresses cortical hyperexcitability in sporadic ALS patients relative to placebo, and, thus, may be able to slow progression in ALS. The change in resting motor threshold (RMT), estimated from single pulse transcranial magnetic stimulation (TMS) measurements made before treatment, after 4 weeks of treatment, and then again after a 4 week washout, will be used as the primary pharmacodynamic marker of cortical hyperexcitability.
You are invited to volunteer for a research study if you have been diagnosed with Amyotrophic Lateral Sclerosis (ALS) within 2 years (24 Months) prior to screening.
This is a non interventional, longitudinal study in patients with ALS. There will be four (4) subject visits in this study: Baseline, month 6, month 12, and month 18. Subjects will have blood and cerebrospinal fluid (a clear fluid found in your brain and spine) collected, and be evaluated with assessment tools that focus on upper and lower motor skills and strength as well as cognitive function. Researchers will use these samples to study ALS, motor neuron disease and other medical conditions.