Open-label Clinical Trial of Lacosamide in ALS
Study Details
Study Description
Brief Summary
Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Lacosamide
|
Drug: Lacosamide
Sodium channel blocker
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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
- Effects on 0.2ms threshold change [Baseline, Week 2 and Week 4]
Measured by latent addition method
- 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
Eligibility Criteria
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
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Patient with cardiac disease (myocardial infarction, valvular disease and cardiomyopathy etc.)
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Patient with arrhythmia (incomplete atrioventricular block and bundle branch block etc.)
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Patient with sodium channel disorders, such as Brugada syndrome
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Patient already administered anti-arrhythmic drug which prolongs PR interval (interval between arterial and ventral contraction measured by ECG)
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Pregnant or breast-feeding woman
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Patient with forced vital capacity of < 60% predicted
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Patient already performed tracheotomy or tube feeding
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Patient who takes any other experimental agents 3 months before.
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Not enough compound muscle action potential amplitude in the median nerve to be performed nerve excitability test
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Patient who plans to change medicine which affects nerve excitability during this trial 4 weeks
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Familial ALS
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Patient who is judged inappropriate for this trail by doctors responsible for this trial
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Chiba University Hospital | Chiba | Japan | 260-8677 |
Sponsors and Collaborators
- Chiba University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- G29007