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

JRCT ID: jRCTs031180173

Registered date:01/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: amyotrophic lateral sclerosis
• Date of first enrollment: 07/07/2017
• Target sample size: 30
• Study type: Interventional
• Intervention(s): gradual increase of lacosamide from 100mg to 400mg for 4 weeks

Outcome(s)

• Primary Outcome: Safety for 5 weeks

Secondary Outcome

nerve excitability
fasciculation
muscle cramp

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Over 20year old
2) Probable of definite ALS disease by Awaji electrophysiological criteria
3) Subjects provided informed consent.

Exclude 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

Related Information

• Primary Sponsor: Kuwabara Satoshi