Open-label Clinical Trial of Lacosamide in ALS

Study Overview
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Brief Summary
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Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS).

Detailed Description
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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.

Official Title
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Open-label Clinical Trial: Safety of Lacosamide in Patients With Amyotrophic Lateral Sclerosis

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Drug: Lacosamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Before and after comparison
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lacosamide<br> | Drug: Lacosamide<br>* Sodium channel blocker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Adverse events will be observed at each visit by direct questioning of the subjects, clinical examination, electrocardiogram (ECG), vital signs, vital capacity and laboratory test results. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of fasciculation | Frequency of fasciculation measured by ultrasound and surface electromyogram at baseline, week 2 and week 4. | Baseline, Week 2 and Week 4 | 
| Frequency and extent of muscle cramp | Frequency of muscle cramp and the extent of muscle cramp measured by visual analog scale (VAS) at baseline, week 2 and week 4. | Baseline, Week 2 and Week 4 | 
| Effects on strength-duration time constant | Measured by threshold tracking nerve conduction studies | Baseline, Week 2 and Week 4 | 
| Effects on 0.2ms threshold change | Measured by latent addition method | Baseline, Week 2 and Week 4 | 
| Effects on threshold electrotonus | Measured by threshold tracking nerve conduction studies | Baseline, Week 2 and Week 4 | 
| Effects on recovery cycle | Measured by threshold tracking nerve conduction studies | Baseline, Week 2 and Week 4 |