CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Mexiletine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02781454
NCT02781454Phase 2Completed

Effect of Mexiletine on Cortical Hyperexcitability in Sporadic Amyotrophic Lateral Sclerosis (SALS)

University of Washington·interventional·Posted May 24, 2016·Updated Dec 5, 2019

In Brief

A Phase 2 clinical trial evaluating Mexiletine and Placebo for Sporadic Amyotrophic Lateral Sclerosis. Completed, enrolled 20 participants across 10 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 24, 2016
Enrollment StartOct 1, 2016
Primary CompletionSep 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 10.1 years ago

Interventions

Mexiletinedrug

Placebodrug