Open-label Clinical Trial of Lacosamide in ALS

Sponsor
Chiba University (Other)
Overall Status
Completed
CT.gov ID
NCT03186040
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Before and after comparisonBefore 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 :
Jul 13, 2017
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
May 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Lacosamide

Drug: Lacosamide
Sodium channel blocker

Outcome Measures

Primary Outcome Measures

  1. Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [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 [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 [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 [Baseline, Week 2 and Week 4]

    Measured by threshold tracking nerve conduction studies

  4. Effects on 0.2ms threshold change [Baseline, Week 2 and Week 4]

    Measured by latent addition method

  5. Effects on threshold electrotonus [Baseline, Week 2 and Week 4]

    Measured by threshold tracking nerve conduction studies

  6. Effects on recovery cycle [Baseline, Week 2 and Week 4]

    Measured by threshold tracking nerve conduction studies

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chiba University Hospital Chiba Japan 260-8677

Sponsors and Collaborators

  • Chiba University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Satoshi Kuwabara, Professor, Chiba University
ClinicalTrials.gov Identifier:
NCT03186040
Other Study ID Numbers:
  • G29007
First Posted:
Jun 14, 2017
Last Update Posted:
Jul 15, 2020
Last Verified:
Jul 1, 2020
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:

Study Results

No Results Posted as of Jul 15, 2020