Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (Mexiletine-2)
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ClinicalTrials.gov Identifier: NCT02781454 |
Recruitment Status :
Completed
First Posted : May 24, 2016
Results First Posted : December 5, 2019
Last Update Posted : December 5, 2019
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Sponsor:
University of Washington
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Michael D Weiss, University of Washington
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Sporadic Amyotrophic Lateral Sclerosis |
Interventions |
Drug: Mexiletine Drug: Placebo |
Enrollment | 20 |
Participant Flow
Recruitment Details | Subjects were enrolled at 9 Northeast ALS Consortium (NEALS) centers in the US. These NEALS centers were academic clinical research centers with established practices where sporadic ALS (sALS) patients are regularly seen and treated. |
Pre-assignment Details | Within 21 days prior to treatment assignment, patients were screened for eligibility based on inclusion/exclusion criteria. Failure to meet any of these criteria at the time of this screening would result in exclusion from the study, and these patients would not be assigned to a treatment group. |
Arm/Group Title | Mexiletine, 300 Milligrams | Mexiletine, 600 Milligrams | Placebo |
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Mexiletine, 300 milligrams by mouth per day for 4 weeks. Mexiletine |
Mexiletine, 600 milligrams by mouth per day for 4 weeks. Mexiletine |
Placebo, by mouth per day for 4 weeks. Placebo |
Period Title: Overall Study | |||
Started | 8 | 6 | 6 |
Completed | 8 | 6 | 5 |
Not Completed | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Mexiletine, 300 Milligrams | Mexiletine, 600 Milligrams | Placebo | Total | |
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Mexiletine, 300 milligrams by mouth per day for 4 weeks. Mexiletine |
Mexiletine, 600 milligrams by mouth per day for 4 weeks. Mexiletine |
Placebo, by mouth per day for 4 weeks. Placebo |
Total of all reporting groups | |
Overall Number of Baseline Participants | 8 | 6 | 6 | 20 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 8 participants | 6 participants | 6 participants | 20 participants | |
58.5 (10.8) | 60.5 (14.1) | 52.0 (11.3) | 57.2 (11.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 6 participants | 6 participants | 20 participants | |
Female |
3 37.5%
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2 33.3%
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1 16.7%
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6 30.0%
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Male |
5 62.5%
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4 66.7%
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5 83.3%
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14 70.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 6 participants | 6 participants | 20 participants | |
Hispanic or Latino |
0 0.0%
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1 16.7%
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0 0.0%
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1 5.0%
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Not Hispanic or Latino |
8 100.0%
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5 83.3%
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6 100.0%
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19 95.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 6 participants | 6 participants | 20 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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White |
8 100.0%
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6 100.0%
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6 100.0%
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20 100.0%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 8 participants | 6 participants | 6 participants | 20 participants |
8 100.0%
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6 100.0%
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6 100.0%
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20 100.0%
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El Escorial Diagnosis
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 6 participants | 6 participants | 20 participants | |
Possible |
1 12.5%
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0 0.0%
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3 50.0%
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4 20.0%
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Prob Lab Supported |
5 62.5%
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5 83.3%
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2 33.3%
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12 60.0%
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Probable |
2 25.0%
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0 0.0%
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1 16.7%
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3 15.0%
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Definite |
0 0.0%
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1 16.7%
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0 0.0%
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1 5.0%
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[1]
Measure Description: Participants were classified according to the El Escorial World Federation of Neurology Criteria for the Diagnosis of ALS (Brooks J Neurol Sci 1994) based on the extent of ALS disease signs and symptoms consistent with neurodegeneration of upper and lower motor neurons
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Michael D. Weiss |
Organization: | University of Washington |
Phone: | 206-598-7688 |
EMail: | mdweiss@uw.edu |
Responsible Party: | Michael D Weiss, University of Washington |
ClinicalTrials.gov Identifier: | NCT02781454 |
Other Study ID Numbers: |
MX-ALS-002 |
First Submitted: | May 10, 2016 |
First Posted: | May 24, 2016 |
Results First Submitted: | October 6, 2019 |
Results First Posted: | December 5, 2019 |
Last Update Posted: | December 5, 2019 |