Open-label Clinical Trial of Lacosamide in ALS

Chiba University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Drug: Lacosamide

Study type

Interventional

Funder types

Other

Identifiers

NCT03186040

G29007

Details and patient eligibility

About

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

Full description

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.

Enrollment

7 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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