Mexiletine for the Treatment of Muscle Cramps in ALS

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01811355
• Date of registration: 06/03/2013
• Prospective Registration: Yes
• Primary sponsor: Bjorn Oskarsson, MD
• Public title: Mexiletine for the Treatment of Muscle Cramps in ALS
• Scientific title: Mexiletine for the Treatment of Muscle Cramps in ALS
• Date of first enrolment: May 2013
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01811355
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Bjorn Oskarsson, MD
• Affiliation: UC Davis

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 89 Years
Gender: All

Health Condition(s) or Problem(s) studied

Muscle Cramps in Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: Placebo

Drug: Mexiletine

Primary Outcome(s)

Cramp Severity [Time Frame: 6 weeks]

Daily Muscle Cramps [Time Frame: 6 weeks]

Secondary ID(s)

378164

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ALS Association

University of California, Davis

Results

• Results available: Yes
• Date Posted: 27/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01811355