Open-label Clinical Trial of Lacosamide in ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Open-label Clinical Trial: Safety of Lacosamide in Patients With Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186040
• Other study ID #: G29007
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 13, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: July 2020
• Source: Chiba University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• Lacosamide
Sodium channel blocker

Locations

Country	Name	City	State
Japan	Chiba University Hospital	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Chiba University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	Frequency of fasciculation	Frequency of fasciculation measured by ultrasound and surface electromyogram at baseline, week 2 and week 4.	Baseline, Week 2 and Week 4
Secondary	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.	Baseline, Week 2 and Week 4
Secondary	Effects on strength-duration time constant	Measured by threshold tracking nerve conduction studies	Baseline, Week 2 and Week 4
Secondary	Effects on 0.2ms threshold change	Measured by latent addition method	Baseline, Week 2 and Week 4
Secondary	Effects on threshold electrotonus	Measured by threshold tracking nerve conduction studies	Baseline, Week 2 and Week 4
Secondary	Effects on recovery cycle	Measured by threshold tracking nerve conduction studies	Baseline, Week 2 and Week 4