Mexiletine for the Treatment of Muscle Cramps in ALS

Completed · Phase 4 · Has a placebo group

Conditions studied: Muscle Cramps in Amyotrophic Lateral Sclerosis

In brief

The purpose of this study is to determine if mexiletine is effective for the treatment of muscle cramps in Amyotrophic Lateral Sclerosis (ALS).

Key facts

Study ID

NCT01811355

Run by

Bjorn Oskarsson, MD

People needed

23

Starts

2013-05-01

Expected to finish

2016-05-01

Last updated by the study team

2017-08-28

Who can join

Age: 21 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ALS diagnosed according to El Escorial criteria (Awaji version) as: Possible, Probable, or Definite.
• Experiencing cramps as a moderate or severe symptom as defined by willingness to take a medication for the symptom
• ≥2 cramps per week during run in week
• Life expectancy > 6 months, estimated by clinician
• Able to take drug capsule by mouth
• No significant EKG abnormality on screening
• aspartate aminotransferase / alanine aminotransferase <2x upper limit of normal measured at screening
• Having successfully filled out the cramp diary and cramp and fasciculation scales on six out of the last seven days of run in period

You may not qualify if…

• Inability to communicate by telephone or email
• Allergy/ known sensitivity to mexiletine
• Prior use of mexiletine
• AV block unless subject has pacemaker
• Cardiac arrhythmia
• Prior myocardial infarction
• Other significant EKG abnormality
• Liver disease
• History of leucopenia (WBC <3,500/mm3)
• Epilepsy
• Other serious and unstable medical condition
• Pregnant woman
• Breastfeeding woman
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
• Use of quinidine (alone or as a component of Nuedexta®) during the study
• Inability or unwillingness of subject to give written informed consent
• Woman of childbearing potential, not willing to use at least two approved methods of contraception
• Use of a prohibited medication during study

Where it is running

• UCD Telehealth Network - Lake Almanor Clinic — Chester, California, United States
• UCSD Department of Neurosciences ALS Clinical Trials (ACT) Program — La Jolla, California, United States
• UCLA Neuromuscular Research Program — Los Angeles, California, United States
• UCD Telehealth Network — Multiple Locations, California, United States
• UC Irvine Health ALS & Neuromuscular Center — Orange, California, United States
• UC, Davis Medical Center ALS Clinic — Sacramento, California, United States

Full record on ClinicalTrials.gov

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