Open-label Clinical Trial of Lacosamide in ALS

Open-label Clinical Trial: Safety of Lacosamide in Patients With Amyotrophic Lateral Sclerosis

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

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Drug: Lacosamide

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan, 260-8677
    • Chiba University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Lacosamide	Drug: Lacosamide; Sodium channel blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chiba University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 13, 2017
• Primary Completion (ACTUAL): April 30, 2020
• Study Completion (ACTUAL): May 31, 2020

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 10, 2017
• First Posted (ACTUAL): June 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: G29007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No