Back to resultsOpen-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
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis
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
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
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
Learn more about this trial
Open-label Clinical Trial of Lacosamide in ALS
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