Mexiletine in Sporadic Amyotrophic Lateral Sclerosis
United States20 participantsStarted 2016-10
Plain-language summary
The purpose of this research study is to find out whether the drug mexiletine will be effective in lowering motor neuron electrical activity in the brains and nerves in the arms of people with ALS. The investigators will also determine if there are any signs that the drug may slow down the progression of ALS and reduce muscle cramps and muscle twitching. This will be determined through transcranial magnetic stimulation (TMS) and threshold tracking nerve conduction studies (TTNCS). In this trial, the participants will be taking either 300mg/day of mexiletine, 600mg/day of mexiletine, or placebo (non-active study drug).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or definite ALS as defined by revised El Escorial criteria.
✓. Age 18 years or older.
✓. Symptom onset of weakness or spasticity due to ALS ≤ 60 months prior to Screening Visit.
✓. Slow vital capacity (SVC) measure ≥50% of predicted for gender, height, and age at the screening visit.
✓. Must be able to swallow capsules throughout the course of the study, according to Site Investigator judgment.
✓. Capable of providing informed consent and following trial procedures.
✓. For TMS: a resting motor threshold defined as 50% of pulses eliciting a motor evoked potential (MEP) of amplitude ≥ 50 µV.
✓. For TTNCS: median Compound Muscle Action Potential (CMAP) ≥ 1.5 mV.
Exclusion criteria
✕. Invasive ventilator dependence, such as tracheostomy.
What they're measuring
1
Change in Resting Motor Threshold
Timeframe: Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 and from Week 4 to Week 8 reported