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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-jRCTs031180173 |
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Date of registration:
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01/03/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis
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Scientific title:
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Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis |
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Date of first enrolment:
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07/07/2017 |
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Target sample size:
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30 |
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Recruitment status: |
Complete |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCTs031180173 |
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Study type:
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Interventional |
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Study design:
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single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose
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Phase:
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1-2
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Contacts
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Name:
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Kazumoto
Shibuya |
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Address:
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1-8-1 Inohana Chuo-ku, Chiba, Chiba prefecture
260-8677
Chiba
Japan |
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Telephone:
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+81-43-226-2129 |
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Email:
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kazumoto@net.email.ne.jp |
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Affiliation:
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Chiba University Hospital |
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Name:
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Satoshi
Kuwabara |
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Address:
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1-8-1 Inohana Chuo-ku, Chiba, Chiba prefecture
260-8677
Chiba
Japan |
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Telephone:
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+81-43-226-2129 |
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Email:
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kuwabara-s@faculty.chiba-u.jp |
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Affiliation:
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Chiba University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) Over 20year old
2) Probable of definite ALS disease by Awaji electrophysiological criteria
3) Subjects provided informed consent.
Exclusion criteria: 1) Patient without ability to comprehend informed consent
2) Patient with uncompensated medical illness
3) Patient with cardiac disease (myocardial infarction, valvular disease and cardiomyopathy etc.)
4) Patient with arrhythmia (incomplet AV-block and bundle branch block etc.)
5) Patient with sodium channel disorders, like Brugada syndrome
6) Patient already administered anti-arrhythmic drug which prolongs PR interval
7) Pregnant or breast-feeding women
8) Patient with forced vital capacity of< 60% predicted
9) Patient already performed tracheotomy or tube feeding
10) Patient take any other experimental agents 3 months before.
11) Not enough CMAP amplitude in the median nerve to be performed nerve excitability test
12) Patient plan to change medicine which affects nerve excitability
13) Familial ALS
14) Patient who is judged inappropriate for this trail by doctors responsible for this trial
Age minimum:
>= 20age old
Age maximum:
Not applicable
Gender:
Both
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Health Condition(s) or Problem(s) studied
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G122
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amyotrophic lateral sclerosis
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amyotrophic lateral sclerosis
amyotrophic lateral sclerosis
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Intervention(s)
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gradual increase of lacosamide from 100mg to 400mg for 4 weeks
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Primary Outcome(s)
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Safety for 5 weeks
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Secondary Outcome(s)
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nerve excitability
fasciculation
muscle cramp
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Source(s) of Monetary Support
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Ethics review
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Status: Approval
Approval date:
Contact:
prc-jim@chiba-u.jp
Chiba University Certified Clinical Research Review Board
+81-43-226-2616
prc-jim@chiba-u.jp
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Results
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Results available:
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Yes |
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Date Posted:
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30/11/2020 |
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Date Completed:
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07/06/2018 |
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URL:
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