The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS).
Condition or disease
Amyotrophic Lateral Sclerosis
Phase 1Phase 2
Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS). This clinical trial is open-label, single group and before and after comparison study. Dosage of lacosamide is increased from 100mg to 400mg for 4 weeks. Safety of lacosamide administration in ALS is primary endpoint. Nerve excitability, fasciculation and muscle cramp are investigated before and after administration for secondary endpoints.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Over 20 year old
Probable or definite ALS disease evaluated by Awaji electrophysiological criteria
Subjects provided informed consent.
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
Patient who is judged inappropriate for this trail by doctors responsible for this trial