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CompletedNCT03186040Updated Jul 15, 2020

Open-label Clinical Trial of Lacosamide in ALS

A Phase 1/2 interventional study of Lacosamide in Amyotrophic Lateral Sclerosis, sponsored by Chiba University. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-07-15.

Sponsored by Chiba University · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis
03

In context

Amyotrophic Lateral Sclerosis

978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.

This study's enrollment of 7 is below the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

Chiba University is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Over 20 year old
  • Probable or definite ALS disease evaluated by Awaji electrophysiological criteria
  • Subjects provided .

Exclusion criteria

Exclusion Criteria:

  • Patient without ability to comprehend
  • 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 )
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Other
    Lacosamide

    Drug: Lacosamide

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

Secondary outcomes

  1. Frequency of fasciculation

    Frequency of fasciculation measured by ultrasound and surface electromyogram at baseline, week 2 and week 4.

    Time frame: Baseline, Week 2 and Week 4

  2. 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.

    Time frame: Baseline, Week 2 and Week 4

  3. Effects on strength-duration time constant

    Measured by threshold tracking nerve conduction studies

    Time frame: Baseline, Week 2 and Week 4

  4. Effects on 0.2ms threshold change

    Measured by latent addition method

    Time frame: Baseline, Week 2 and Week 4

  5. Effects on threshold electrotonus

    Measured by threshold tracking nerve conduction studies

    Time frame: Baseline, Week 2 and Week 4

  6. Effects on recovery cycle

    Measured by threshold tracking nerve conduction studies

    Time frame: Baseline, Week 2 and Week 4

07

Study locations

1 site
  • Chiba University Hospital
    Chiba, 260-8677, Japan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2017 to primary completion in Apr 2020, 33 months.

Of 36 phase 1/2 interventional studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 57. This study's 33 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2017
First posted
Jun 14, 2017
StartActual
Jul 13, 2017
Primary completionActual
Apr 30, 2020
CompletionActual
May 31, 2020
Last update
Jul 15, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03186040
Lead sponsor
Chiba University
Responsible party
Satoshi Kuwabara (Professor, Chiba University) — Principal investigator
First posted
Jun 14, 2017
Start date
Jul 13, 2017
Primary completion
Apr 30, 2020
Completion
May 31, 2020
Last update
Jul 15, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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