Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Sodium channel blocker
Chiba University Hospital
Chiba, Japan
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.
Time frame: 4 weeks
Frequency of fasciculation
Frequency of fasciculation measured by ultrasound and surface electromyogram at baseline, week 2 and week 4.
Time frame: 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.
Time frame: Baseline, Week 2 and Week 4
Effects on strength-duration time constant
Measured by threshold tracking nerve conduction studies
Time frame: Baseline, Week 2 and Week 4
Effects on 0.2ms threshold change
Measured by latent addition method
Time frame: Baseline, Week 2 and Week 4
Effects on threshold electrotonus
Measured by threshold tracking nerve conduction studies
Time frame: Baseline, Week 2 and Week 4
Effects on recovery cycle
Measured by threshold tracking nerve conduction studies
Time frame: Baseline, Week 2 and Week 4
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