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Open-label Clinical Trial of Lacosamide in ALS

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ClinicalTrials.gov Identifier: NCT03186040
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Satoshi Kuwabara, Chiba University

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

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Lacosamide Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Before and after comparison
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Clinical Trial: Safety of Lacosamide in Patients With Amyotrophic Lateral Sclerosis
Actual Study Start Date : July 13, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 31, 2020


Arm Intervention/treatment
Lacosamide Drug: Lacosamide
Sodium channel blocker




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: 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 :
  1. Frequency of fasciculation [ Time Frame: Baseline, Week 2 and Week 4 ]
    Frequency of fasciculation measured by ultrasound and surface electromyogram at baseline, week 2 and week 4.

  2. Frequency and extent of muscle cramp [ Time Frame: 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.

  3. Effects on strength-duration time constant [ Time Frame: Baseline, Week 2 and Week 4 ]
    Measured by threshold tracking nerve conduction studies

  4. Effects on 0.2ms threshold change [ Time Frame: Baseline, Week 2 and Week 4 ]
    Measured by latent addition method

  5. Effects on threshold electrotonus [ Time Frame: Baseline, Week 2 and Week 4 ]
    Measured by threshold tracking nerve conduction studies

  6. Effects on recovery cycle [ Time Frame: Baseline, Week 2 and Week 4 ]
    Measured by threshold tracking nerve conduction studies



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186040


Locations
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Japan
Chiba University Hospital Recruiting
Chiba, Japan, 260-8677
Contact: Kazumoto Shibuya, MD, PhD    +81432262129 ext 5414    kazumoto@net.email.ne.jp   
Sponsors and Collaborators
Chiba University

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Responsible Party: Satoshi Kuwabara, Professor, Chiba University
ClinicalTrials.gov Identifier: NCT03186040     History of Changes
Other Study ID Numbers: G29007
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

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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

Additional relevant MeSH terms:
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Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action