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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | Sodium channel blocker |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba University Hospital | Chiba | 260-8677 | Japan |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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Before and after comparison
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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 |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |