Open-label Clinical Trial of Lacosamide in ALS

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Drug: Lacosamide

• Registration Number: NCT03186040
• Lead Sponsor: Chiba University

Brief Summary

Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS).

Detailed Description

Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS). This clinical trial is open-label, single group and before and after comparison study. Dosage of lacosamide is increased from 100mg to 400mg for 4 weeks. Safety of lacosamide administration in ALS is primary endpoint. Nerve excitability, fasciculation and muscle cramp are investigated before and after administration for secondary endpoints.

Study Timeline

• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-10
• Study First Posted: 2017-06-14
• Study Start: 2017-07-13
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacosamide	Lacosamide	-

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0	4 weeks	Adverse events will be observed at each visit by direct questioning of the subjects, clinical examination, electrocardiogram (ECG), vital signs, vital capacity and laboratory test results.

Secondary Outcome Measures

Name	Time	Method
Frequency of fasciculation	Baseline, Week 2 and Week 4	Frequency of fasciculation measured by ultrasound and surface electromyogram at baseline, week 2 and week 4.
Frequency and extent of muscle cramp	Baseline, Week 2 and Week 4	Frequency of muscle cramp and the extent of muscle cramp measured by visual analog scale (VAS) at baseline, week 2 and week 4.
Effects on strength-duration time constant	Baseline, Week 2 and Week 4	Measured by threshold tracking nerve conduction studies
Effects on 0.2ms threshold change	Baseline, Week 2 and Week 4	Measured by latent addition method
Effects on threshold electrotonus	Baseline, Week 2 and Week 4	Measured by threshold tracking nerve conduction studies
Effects on recovery cycle	Baseline, Week 2 and Week 4	Measured by threshold tracking nerve conduction studies

Trial Locations

Locations (1)

Chiba University Hospital; 🇯🇵 Chiba, Japan