The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosis
- Conditions
- amyotrophic lateral sclerosis
- Registration Number
- JPRN-UMIN000006423
- Lead Sponsor
- Department of Neurology, Graduate School of Medicine, Chiba University, Japan.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
1)Patient did not have ability to comprehend informed consent 2)Patient had uncompensated medical illness 3)Patient had cardiac disease (myocardial infarction, valvular disease and cardiomyopathy etc.) 4)Patient had arrhythmia (incomplet AV-block and bundle branch block etc.) 5)Significant sinus bradycardia 6)Hypotension 7)Hypokalemia 8)Patient already administered anti-arrhythmic drug 9)Woman is pregnant or is breast-feeding 10)Subjects had forced vital capacity of< 60% predicted 11)Subjects were not allowed to take any other experimental agents 3 months before. 12)Subjects had concomitant disease effects peripheral nerve (diabetic peripheral neuropathy, hyperglycemia, ypercapnia etc.) 13)Not evoled CMAP amplitude in median nerve 14)Patient already performed tracheotomy or tube feeding. 15)Patient with disease duration of less than 36 months at study entry. 16)Patient had family history of amyotorphic lateral sclerosis. 17)Patient already administered other drug (procaine amide, quinidine, aprindine, amoxapine, antiepileptic drug). If patient suspend the administration of these drugs, they had possibility to exacerbate illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The reduction of ALS Functional Rating Scale Revised
- Secondary Outcome Measures
Name Time Method