Amyotrophic Lateral Sclerosis
Conditions
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.
Interventions
DRUGLacosamide
Sodium channel blocker
Sponsors
Chiba University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Before and after comparison
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and extent of muscle cramp | Baseline, Week 2 and Week 4 | Frequency of muscle cramp and the extent of muscle cramp measured by visual analog scale (VAS) at baseline, week 2 and week 4. |
| Effects on strength-duration time constant | Baseline, Week 2 and Week 4 | Measured by threshold tracking nerve conduction studies |
| Frequency of fasciculation | Baseline, Week 2 and Week 4 | Frequency of fasciculation measured by ultrasound and surface electromyogram at baseline, week 2 and week 4. |
| Effects on threshold electrotonus | Baseline, Week 2 and Week 4 | Measured by threshold tracking nerve conduction studies |
| Effects on recovery cycle | Baseline, Week 2 and Week 4 | Measured by threshold tracking nerve conduction studies |
| Effects on 0.2ms threshold change | Baseline, Week 2 and Week 4 | Measured by latent addition method |
Countries
Japan
Outcome results
None listed