Mexiletine, capsule, 150mg, PO BID, 14 days

A total of 23 subjects were enrolled. 11 were randomized to receive study drug first, followed by placebo. 12 subjects received placebo first and study drug second. Overall participant characteristics are displayed in the baseline table.

Total Subjects Enrolled

Age, Customized

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

The average of the daily recording of number of muscle cramps that occurred in the last 24 hours- over a 6 week period.

Mexiletine, capsule, 150mg, PO BID, 14 days
Placebo, capsule, PO BID, 14 days

Mexiletine First/Placebo Second

Placebo, capsule, PO BID, 14 days
Mexiletine, capsule, 150mg, PO BID, 14 days

Placebo First/Mexiletine Second

Daily Muscle Cramps

Daily cramp severity was rated on the 100-unit visual analog scale. Scores ranged from 0 to 100, with 100 being the greatest amount of cramp severity

Mexiletine, capsule, 150mg, PO BID, 14 days
Mexiletine: Sodium channel blocker

Mexiletine First

Placebo, capsule, PO BID, 14 days
Placebo: Placebo

Placebo First

Cramp Severity

First Dose

Washout

Second Dose

Dr. Bjorn Oskarsson

Mexiletine

Placebo

Muscle Cramps in Amyotrophic Lateral Sclerosis

UCD Telehealth Network - Lake Almanor Clinic

UCSD Department of Neurosciences ALS Clinical Trials (ACT) Program

UCLA Neuromuscular Research Program

UCD Telehealth Network

UC Irvine Health ALS & Neuromuscular Center

UC, Davis Medical Center ALS Clinic

Mexiletine for the Treatment of Muscle Cramps in ALS

Bjorn Oskarsson, MD

Assistant Professor of Clinical Neurology

University of California, Davis

ALS Association

Subjects having either definite or probable ALS by El Escorial Criteria.

Amyotrophic Lateral Sclerosis

MDA/ALS Center of Hope

Non-Invasive Measurement of Gastrointestinal (GI) Motility in Patients With Amyotrophic Lateral Sclerosis (ALS)

Non-Invasive Measurement of GI Motility in Patients With ALS

GI Transit Time is determined by measuring the levels of hydrogen gas in exhaled breath using a Hydrogen Meter.

Christine Barr

Primary contact

Open-label minocycline treatment at 1.4 mg/kg/day

Minocycline

Sex: Female, Male

The Mann-Whitney U-test was used to compare pre-/post-treatment differences in analyte concentrations in serum, plasma and CSF. The Mann-Whitney U test generates a z-score test statistic with an associated p value. A negative z-statistic reflects a decrease in analyte level from pre- to post-treatment. Statistical significance level was set at 0.05. There is one test statistic (z-score) per analyte, reflecting the pre-post comparison across all subjects.
Pre and post treatment measurements of csf analytes: TNF alpha, Il-6, CCL-2(MCP-1), CCL3 (MIP-1alpha), CCL5(RANTES), CXCL(IL-8), BDNF, CD40L, GDNF, HGF, Leptin

z Score

This instrument has two scales - Severity (CGI-S). The CGI-S is a seven point scale with a minimum score of 1 and a maximum score as 7 as follows: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.

Clinical Global Impressions Scale-Severity (CGI). (Connors & Barkley, 1985)

Overall Study

Dr. Susan Swedo

Overall Study/Minocycline

Autism

Regressive Autism

Childrens National Medical Center

National Institutes of Health Clinical Center, 9000 Rockville Pike

Minocycline to Treat Childhood Regressive Autism

Treatment of Childhood Regressive Autism With Minocycline: an Anti-Inflammatory Agent Active Within the CNS

National Institute of Mental Health (NIMH)