Amyotrophic Lateral SclerosisPhase 1/2NCT03186040
Open-label Clinical Trial of Lacosamide in ALS
A Phase 1/2 study testing Lacosamide in people with Amyotrophic Lateral Sclerosis, run by Chiba University at 1 site in Japan.
Trial summary
Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Lacosamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteJapan
- Study dates
- 13 Jul 2017to 31 May 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 20 year old
- Probable or definite ALS disease evaluated by Awaji electrophysiological criteria
- Subjects provided informed consent.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Clinical Trial: Safety of Lacosamide in Patients With Amyotrophic Lateral Sclerosis
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Lacosamide
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideDrug
Sodium channel blocker
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | Other | Not described Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (6)
Frequency of fasciculation
Frequency of fasciculation measured by ultrasound and surface electromyogram at baseline, week 2 and week 4.
Measured: 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.
Measured: Baseline, Week 2 and Week 4
Effects on strength-duration time constant
Measured by threshold tracking nerve conduction studies
Measured: Baseline, Week 2 and Week 4
Effects on 0.2ms threshold change
Measured by latent addition method
Measured: Baseline, Week 2 and Week 4
Effects on threshold electrotonus
Measured by threshold tracking nerve conduction studies
Measured: Baseline, Week 2 and Week 4
Effects on recovery cycle
Measured by threshold tracking nerve conduction studies
Measured: Baseline, Week 2 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start13 Jul 2017
- Primary completion30 Apr 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before and after comparison
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiba University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satoshi Kuwabara, Chiba University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186040
- Sponsor's protocol ID
- G29007
- Status last verified
- Jul 2020
- First submitted
- 5 Jun 2017
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Clinical Trial: Safety of Lacosamide in Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT03186040
- Acronym / sponsor ID
- G29007
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Chiba UniversityUniversity, hospital or other
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and after comparison
| Arm | Type | Receives |
|---|---|---|
| Lacosamide | Other | Drug: Lacosamide |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 20 year old
- Probable or definite ALS disease evaluated by Awaji electrophysiological criteria
- Subjects provided informed consent.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LacosamideSodium channel blocker | Drug | Lacosamide |
Primary outcome
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.
6 secondary outcomes
Frequency of fasciculation
Time frame: Baseline, Week 2 and Week 4
Frequency and extent of muscle cramp
Time frame: Baseline, Week 2 and Week 4
Effects on strength-duration time constant
Time frame: Baseline, Week 2 and Week 4
Effects on 0.2ms threshold change
Time frame: Baseline, Week 2 and Week 4
Effects on threshold electrotonus
Time frame: Baseline, Week 2 and Week 4
Effects on recovery cycle
Time frame: Baseline, Week 2 and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lacosamide in people with Amyotrophic Lateral Sclerosis, run by Chiba University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.