At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 75 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.
A Safety and Tolerability Study of Mexiletine in Patients With Sporadic Amyotrophic Lateral Sclerosis (SALS)
In Brief
A Phase 2 clinical trial evaluating Mexiletine and Placebo for Sporadic Amyotrophic Lateral Sclerosis. Completed, enrolled 75 participants across 10 sites.
Detailed Summary
The purpose of this research is to find out if mexiletine is safe and effective in people with Amyotrophic Lateral Sclerosis (ALS). In this trial, participants will be taking either 300 milligrams per day of mexiletine, 900 milligrams per day of mexiletine or placebo (non-active study drug). The safety and efficacy of these doses will be compared to see if one dose is better than the other.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSporadic Amyotrophic Lateral Sclerosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartJul 2013
Primary CompletionAug 2014
TodayJul 2026
First PostedMay 8, 2013
Enrollment StartJul 1, 2013
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.2 years ago
Interventions
Mexiletinedrug
Placebodrug