Clinical trial NCT03186040: Open-label Clinical Trial of Lacosamide in ALS
Official title: Open-label Clinical Trial: Safety of Lacosamide in Patients With Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Chiba University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before and after comparison
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
timeFrame: 4 weeks
Secondary outcomes:
measure: Frequency of fasciculation
timeFrame: Baseline, Week 2 and Week 4
measure: Frequency and extent of muscle cramp
timeFrame: Baseline, Week 2 and Week 4
measure: Effects on strength-duration time constant
timeFrame: Baseline, Week 2 and Week 4
measure: Effects on 0.2ms threshold change
timeFrame: Baseline, Week 2 and Week 4
measure: Effects on threshold electrotonus
timeFrame: Baseline, Week 2 and Week 4
measure: Effects on recovery cycle
timeFrame: Baseline, Week 2 and Week 4
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Chiba University Hospital
Study officials:
References: