Open-label Clinical Trial of Lacosamide in ALS

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03186040
• Date of registration: 05/06/2017
• Prospective Registration: Yes
• Primary sponsor: Chiba University
• Public title: Open-label Clinical Trial of Lacosamide in ALS
• Scientific title: Open-label Clinical Trial: Safety of Lacosamide in Patients With Amyotrophic Lateral Sclerosis
• Date of first enrolment: July 13, 2017
• Target sample size: 7
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03186040
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Japan

Key inclusion & exclusion 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

- Patient with cardiac disease (myocardial infarction, valvular disease and
cardiomyopathy etc.)

- Patient with arrhythmia (incomplete atrioventricular block and bundle branch block
etc.)

- Patient with sodium channel disorders, such as Brugada syndrome

- Patient already administered anti-arrhythmic drug which prolongs PR interval (interval
between arterial and ventral contraction measured by ECG)

- Pregnant or breast-feeding woman

- Patient with forced vital capacity of < 60% predicted

- Patient already performed tracheotomy or tube feeding

- Patient who takes any other experimental agents 3 months before.

- Not enough compound muscle action potential amplitude in the median nerve to be
performed nerve excitability test

- Patient who plans to change medicine which affects nerve excitability during this
trial 4 weeks

- Familial ALS

- Patient who is judged inappropriate for this trail by doctors responsible for this
trial



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: Lacosamide

Primary Outcome(s)

Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [Time Frame: 4 weeks]

Secondary Outcome(s)

Frequency and extent of muscle cramp [Time Frame: Baseline, Week 2 and Week 4]

Effects on 0.2ms threshold change [Time Frame: Baseline, Week 2 and Week 4]

Frequency of fasciculation [Time Frame: Baseline, Week 2 and Week 4]

Effects on strength-duration time constant [Time Frame: Baseline, Week 2 and Week 4]

Effects on threshold electrotonus [Time Frame: Baseline, Week 2 and Week 4]

Effects on recovery cycle [Time Frame: Baseline, Week 2 and Week 4]

Secondary ID(s)

G29007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors