NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180173

Registered date:01/03/2019

Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedamyotrophic lateral sclerosis
Date of first enrollment07/07/2017
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)gradual increase of lacosamide from 100mg to 400mg for 4 weeks

Outcome(s)

Primary OutcomeSafety for 5 weeks
Secondary Outcomenerve excitability fasciculation muscle cramp

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1) Over 20year old 2) Probable of definite ALS disease by Awaji electrophysiological criteria 3) Subjects provided informed consent.
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Kazumoto Shibuya
Address 1-8-1 Inohana Chuo-ku, Chiba, Chiba prefecture Chiba Japan 260-8677
Telephone +81-43-226-2129
E-mail kazumoto@net.email.ne.jp
Affiliation Chiba University Hospital
Scientific contact
Name Satoshi Kuwabara
Address 1-8-1 Inohana Chuo-ku, Chiba, Chiba prefecture Chiba Japan 260-8677
Telephone +81-43-226-2129
E-mail kuwabara-s@faculty.chiba-u.jp
Affiliation Chiba University Hospital