Mexiletine for the Treatment of Muscle Cramps in ALS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 6
- 主要终点
- Cramp Severity
研究概览
简要总结
The purpose of this study is to determine if mexiletine is effective for the treatment of muscle cramps in Amyotrophic Lateral Sclerosis (ALS).
详细描述
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 debilitating - could help people living with ALS.
Muscle cramps are sudden, painful, and involuntary contractions of a muscle. They are caused by nerve dysfunction. When we examine nerves and muscles electrically, we see cramps as bursts of high-frequency (up to150 Hz) firing of the motor nerve cells. Cramps in ALS are believed to be the result of an increase of persistent sodium currents in the sick lower motor nerve cells.
A medication called Quinine was for many years the commonly used drug for controlling cramps in ALS, but the FDA has advised against its use for cramps because of its potential risks (e.g., death). Today there is no agreement on how to treat cramps in the ALS. The American Academy of Neurology recently encouraged further studies of the treatment of muscle cramps and suggested lidocaine as one of a few drugs of special interest.
Mexiletine:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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
研究组 & 干预措施
Mexiletine
Mexiletine, capsule, 150mg, PO BID, 14 days
干预措施: Mexiletine (Drug)
Placebo
Placebo, capsule, PO BID, 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Cramp Severity
时间窗: 6 weeks
Daily cramp severity was rated on the 100-unit visual analog scale. Scores ranged from 0 to 100, with 100 being the greatest amount of cramp severity
Daily Muscle Cramps
时间窗: 6 weeks
The average of the daily recording of number of muscle cramps that occurred in the last 24 hours- over a 6 week period.
次要结局
未报告次要终点
研究者
Bjorn Oskarsson, MD
Assistant Professor of Clinical Neurology
University of California, Davis