amyotrophic lateral sclerosis
Conditions
Interventions
administration of mexiletine and riluzole
administration of riluzole only
Sponsors
Department of Neurology, Graduate School of Medicine, Chiba University, Japan.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Over 20 years old. 2)Patient had probable or definite ALS disease, as defined in the Awaji electrophysiological criteria. 3)Subjects provided informed consent.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction of ALS Functional Rating Scale Revised | — |
Countries
Japan
Contacts
Public ContactKazumoto Shibuya
Graduate School of Medicine, Chiba University, Japan. Department of Neurology
Outcome results
None listed