Open-label Clinical Trial of Lacosamide in ALS

NCT03186040 | Completed Phase 1 DMC

• 1 other identifier: G29007
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0

  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.

  4 weeks

Secondary Outcomes (6)

• Frequency of fasciculation

  Baseline, Week 2 and Week 4

• Frequency and extent of muscle cramp

  Baseline, Week 2 and Week 4

• Effects on strength-duration time constant

  Baseline, Week 2 and Week 4

• Effects on 0.2ms threshold change

  Baseline, Week 2 and Week 4

• Effects on threshold electrotonus

  Baseline, Week 2 and Week 4

Study Arms (1)

Lacosamide

OTHER

Drug: Lacosamide

Interventions

Lacosamide DRUG

Sodium channel blocker

Lacosamide

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 20 year old
• Probable or definite ALS disease evaluated by Awaji electrophysiological criteria
• Subjects provided informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiba University: lead

Study Sites (1)

Chiba University Hospital

Chiba, 260-8677, Japan

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Before and after comparison

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 14, 2017
• Study Start: July 13, 2017
• Primary Completion: April 30, 2020
• Study Completion: May 31, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

JP (1)