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Open-label Clinical Trial of Lacosamide in ALS

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Lacosamide
Sponsored by
Chiba University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chiba University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lacosamide

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Frequency of fasciculation
Frequency of fasciculation measured by ultrasound and surface electromyogram at 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.
Effects on strength-duration time constant
Measured by threshold tracking nerve conduction studies
Effects on 0.2ms threshold change
Measured by latent addition method
Effects on threshold electrotonus
Measured by threshold tracking nerve conduction studies
Effects on recovery cycle
Measured by threshold tracking nerve conduction studies

Full Information

First Posted
June 5, 2017
Last Updated
July 13, 2020
Sponsor
Chiba University
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1. Study Identification

Unique Protocol Identification Number
NCT03186040
Brief Title
Open-label Clinical Trial of Lacosamide in ALS
Official Title
Open-label Clinical Trial: Safety of Lacosamide in Patients With Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 13, 2017 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiba University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Before and after comparison
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lacosamide
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Intervention Description
Sodium channel blocker
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Frequency of fasciculation
Description
Frequency of fasciculation measured by ultrasound and surface electromyogram at baseline, week 2 and week 4.
Time Frame
Baseline, Week 2 and Week 4
Title
Frequency and extent of muscle cramp
Description
Frequency of muscle cramp and the extent of muscle cramp measured by visual analog scale (VAS) at baseline, week 2 and week 4.
Time Frame
Baseline, Week 2 and Week 4
Title
Effects on strength-duration time constant
Description
Measured by threshold tracking nerve conduction studies
Time Frame
Baseline, Week 2 and Week 4
Title
Effects on 0.2ms threshold change
Description
Measured by latent addition method
Time Frame
Baseline, Week 2 and Week 4
Title
Effects on threshold electrotonus
Description
Measured by threshold tracking nerve conduction studies
Time Frame
Baseline, Week 2 and Week 4
Title
Effects on recovery cycle
Description
Measured by threshold tracking nerve conduction studies
Time Frame
Baseline, Week 2 and Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan

12. IPD Sharing Statement

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Open-label Clinical Trial of Lacosamide in ALS

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