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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031180173
Enrollment
30
Registered
2019-03-01
Start date
2017-07-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

amyotrophic lateral sclerosis amyotrophic lateral sclerosis

Interventions

Sponsors

Kuwabara Satoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Safety for 5 weeks

Secondary

MeasureTime frame
nerve excitability fasciculation muscle cramp

Contacts

Public ContactKazumoto Shibuya

Chiba University Hospital

kazumoto@net.email.ne.jp+81-43-226-2129

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026