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

Study Purpose:

The purpose of this 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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Active, currently recruiting

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Michael Weiss, MD, Washington University

Clinicaltrials.gov ID (11 digit #):

NCT02781454

Neals Affiliated?

Yes

Coordinating Center Contact Information

MGH - NCRI
Sara Vaughan / .(JavaScript must be enabled to view this email address) / 617-643-5374
Emily Engel / .(JavaScript must be enabled to view this email address) / 617-724-7210
165 Cambridge Street
6th Floor
Boston, Massachusetts 02114 United States

Full Study 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 Sponsor:

ALSA; ALSFAC

Participant Duration:

11 Weeks

Estimated Enrollment:

60

Estimated Study Start Date:

10/01/2016

Estimated Study Completion Date:

05/30/2018

Posting Last Modified Date:

06/13/2017

Date Study Added to alsconsortium.org:

06/27/2016
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    <24

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


  • Site Contact Information

    Augusta University, Georgia Regents
    Kristy Bouchard / .(JavaScript must be enabled to view this email address) / 706-721-2681
    1120 15th Street
    Augusta, Georgia 30912
    United States

    Barrow Neurological Institute
    Nicole Turcotte / .(JavaScript must be enabled to view this email address) / 602-406-4775
    240 W. Thomas Rd.
    Phoenix, Arizona 85013
    United States

    Beth Israel Deaconess Medical Center
    Carmen Shin / .(JavaScript must be enabled to view this email address) / 617-667-3053
    330 Brookline Ave.
    Boston, Massachusetts 02215
    United States

    Columbia University Medical Center
    Jess Singleton / .(JavaScript must be enabled to view this email address) / 212-305-7221
    622 West 168th Street,
    New York, New York 10032
    United States

    Medical University of South Carolina
    Michele DeCandio, RN, OCN, CCRP / .(JavaScript must be enabled to view this email address) / 843-792-9016
    Charleston, South Carolina 29425
    United States

    University of California, Irvine
    Veena Mathew / .(JavaScript must be enabled to view this email address) / 714-456-2864
    200 S Manchester Ave
    Orange, California 92868
    United States

    University of Michigan
    Jayna Duell, BSN, RN / .(JavaScript must be enabled to view this email address) / 734-763-9037
    1500 E. Medical Center Drive
    Ann Arbor, Michigan 48109
    United States

    University of Pittsburgh
    Danielle Rowlands / .(JavaScript must be enabled to view this email address) / 412-864-2873
    200 Lothrop Street
    Pittsburgh, Pennsylvania 15213
    United States

    University of Washington
    Laura Sissons-Ross / .(JavaScript must be enabled to view this email address) / 206-543-0081
    1959 NE Pacific St.
    Seattle, Washington 98195
    United States