Open-label Clinical Trial of Lacosamide in ALS

• Status: Completed
• Trial end date: 2020-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiba University
• Treatments: Lacosamide

Criteria

Inclusion Criteria:

• Over 20 year old

• Probable or definite ALS disease evaluated by Awaji electrophysiological criteria

• Subjects provided informed consent.

Exclusion Criteria:

• Patient without ability to comprehend informed consent

• Patient with uncompensated medical illness

• Patient with cardiac disease (myocardial infarction, valvular disease and cardiomyopathy etc.)

• Patient with arrhythmia (incomplete atrioventricular block and bundle branch block etc.)

• Patient with sodium channel disorders, such as Brugada syndrome

• Patient already administered anti-arrhythmic drug which prolongs PR interval (interval between arterial and ventral contraction measured by ECG)

• Pregnant or breast-feeding woman

• Patient with forced vital capacity of < 60% predicted

• Patient already performed tracheotomy or tube feeding

• Patient who takes any other experimental agents 3 months before.

• Not enough compound muscle action potential amplitude in the median nerve to be performed nerve excitability test

• Patient who plans to change medicine which affects nerve excitability during this trial 4 weeks

• Familial ALS

• Patient who is judged inappropriate for this trail by doctors responsible for this trial