Open-label Clinical Trial of Lacosamide in ALS

NCT ID: NCT03186040

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-13
• Study Completion Date: 2020-05-31

Brief Summary

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

Detailed 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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lacosamide

Group Type: OTHER

Lacosamide

Intervention Type: DRUG

Sodium channel blocker

Interventions

Lacosamide

Sodium channel blocker

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiba University

OTHER

Sponsor Role: lead

Responsible Party

Satoshi Kuwabara

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chiba University Hospital

Chiba, , Japan

Countries

Japan

Other Identifiers

G29007

Identifier Type: -

Identifier Source: org_study_id