Mexiletine for the Treatment of Muscle Cramps in ALS

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bjorn Oskarsson, MD
• Collaborators: ALS Association; University of California, Davis
• Treatments: Mexiletine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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