Status:
COMPLETED
Mexiletine for the Treatment of Muscle Cramps in ALS
Lead Sponsor:
Bjorn Oskarsson, MD
Collaborating Sponsors:
University of California, Davis
ALS Association
Conditions:
Muscle Cramps in Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
21-89 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if mexiletine is effective for the treatment of muscle cramps in Amyotrophic Lateral Sclerosis (ALS).
Detailed Description
Background: Many ALS patients suffer from painful muscle cramps, but unfortunately we do not have any medication proven to help muscle cramps in ALS. Reducing the pain caused by cramps - which can be...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01811355
Start Date
May 1 2013
End Date
May 1 2016
Last Update
August 28 2017
Active Locations (6)
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1
UCD Telehealth Network - Lake Almanor Clinic
Chester, California, United States, 96020
2
UCSD Department of Neurosciences ALS Clinical Trials (ACT) Program
La Jolla, California, United States, 92093
3
UCLA Neuromuscular Research Program
Los Angeles, California, United States, 90095
4
UCD Telehealth Network
Multiple Locations, California, United States, Various