Phase 4
Completed N=23
Mexiletine for the Treatment of Muscle Cramps in ALS
Muscle Cramps in Amyotrophic Lateral Sclerosis
Source: ClinicalTrials.gov NCT01811355 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Daily Muscle Cramps — 6.1; 4.7; 4.9; 2.5 Cramps per 24 hours
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine if mexiletine is effective for the treatment of muscle cramps in Amyotrophic Lateral Sclerosis (ALS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Muscle Cramps |
6.1; 4.7; 4.9; 2.5; 1.2; 2.2 | — |
| PRIMARY Cramp Severity |
43.6; 44.7; 23.1; 32.8; 20.5; 12.0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01811355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.