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• W2913073102 abstract "Objective: To evaluate the effects of mexiletine on ALS patients suffering troubling muscle cramps Background: Muscle cramps affect >90% of ALS patients. Peripheral motor axon hyperexcitability, in part due to increased persistent sodium current, is thought to be the mechanism. Mexiletine a selective persistent sodium current blocker, has been shown to reduce cramp propensity in lower motor neurons and cramps in an ALS cohort not selected for cramps. Design/Methods: Twenty ALS patients suffering cramps completed a double blind multicenter randomized crossover study. The primary outcome measure was daily cramp count. Secondary measures were cramp and fasciculation severity. Patients were randomized to mexiletine 150mg BID or placebo for a 2 week epoch followed by a 1 week washout. Patients then crossed over to a second 2 week epoch. We monitored safety and tolerability. We used three analysis methods: Within subject mean responses using t-test. A fit linear mixed effects model with random effects added to allow for different constants, placebo and drug effects. Analysis of treatment, period and order of treatment effects. Results: Numbers of cramps In 18/20 patients, the mean number of cramps was reduced. Thirteen at p −10 . The linear mixed effect model showed an average reduction of 1.8 (baseline 6) cramps/day (p=0.001). Analysis of the mean number of cramps also showed a treatment effect (p=0.008), while neither period nor sequence were significant (p=0.39 and p=0.7). Cramp severity The linear mixed effects model showed an average severity reduction of 15/100 (baseline 46) (p=0.011). Fasciculation Severity None of the models found a treatment effect. Conclusions: Mexiletine (150mg BID) is an effective treatment for muscle cramps in ALS, reducing frequency and severity. Mexiletine was ineffective at reducing fasciculations. No safety concerns were noted in this short duration randomized placebo-controlled study. Study Supported by: This study was developed at the NINDS Clinical trials methodology course in 2008. Major funding for the study was provided by the University of California Davis CTSC, NCRR UL1 RR024146 regulatory assistance, NIH UL1 TR 000002 and KL2 TR 000134. Additional study support was provided by the ALS Association. Disclosure: Dr. Oskarsson has received personal compensation for activities with Avanir Pharmaceuticals as a speaker. Dr. Oskarsson has received research support from Cytokinetics, Novartis, Neuraltus, and Glaxo. Dr. Moore has nothing to disclose. Dr. Mozaffar has received personal compensation for activities with Sanofi Genzyme, Grifols, Amicus, Biomarin, Idera Pharmaceuticals and Ultragenyx. Dr. Mozaffar has received research support from Cytokinetics, Alexion, Amicus, Biomarin, Grifols, GlaxoSmithKline, Ultragenyx, and Novartis. Dr. Ravits has received personal compensation for activities with Alnylam and Biogen-Idec as a consultant and/or advisory board participant. Dr. Ravits has received license fee payments from Isis Pharmaceuticals. Dr. Wiedau-Pazos has nothing to disclose. Dr. Parziale has nothing to disclose. Dr. Joyce has nothing to disclose. Dr. Mandeville has nothing to disclose. Dr. Goyal has nothing to disclose. Dr. Cudkowicz has received personal compensation for activities with Cytokinetics, Lilly, Astra Zenica, Biohaven, Genentech. Jama Neurology. Dr. Weiss has received personal compensation for activities with Walgreen9s and Nufactor as a speaker. Dr. Weiss has received personal compensation in an editorial capacity for Muscle and Nerve. Dr. Weiss has received research support from ALS Association. Dr. Miller has received personal compensation for activities with Cytokinetics and Synapse Pharmaceuticals. Dr. McDonald has nothing to disclose." @default.
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• W2913073102 date "2017-04-18" @default.
• W2913073102 modified "2023-09-23" @default.
• W2913073102 title "Mexiletine for the treatment of muscle cramps in ALS: a randomized double-blind crossover trial (S38.004)" @default.
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