臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 01, 2019
Last modified on	Nov. 30, 2020
Trial ID	jRCTs031180173

Scientific Title	Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis
Public Title	Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis

Completion date	June. 07, 2018
Result actual enrolment	7
Baseline Characteristics	Seven patients with amyotrophic lateral sclerosis (male; n = 3, female; n= 4, mean age; 63.7yrs)
Participant flow	Informed consent was obtaine from 7 patients (2017; 4 paetients, 2018; 3 patients)
Adverse events	Diplopia, sleepiness, wandering or dizziness for each one case All of these had causal relationships and were objective symptoms.
Outcome measures	Primary endpoint: adverse events seen in 4 cases (see above), no severe adverse event Secondary endpoint: Effectiveness endpoint; no significant changes in nerve excitability testing, transcranial magnetic stimulation, fasciculation and muscle cramps Safety endpoint; objective symptoms (see above), no significant changes in vital capacity, electrocardiogram, blood test and severe advrse enents (see above).
Brief summary	Safety has been confirmed, because all of adverse events were already known, and severe advrse enents were not observed.
Date of posting of results summaries	Nov. 30, 2020
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	No plan for sharing.
URL link to protocol file(s) with version and date	https://jrct.niph.go.jp/latest-detail/jRCTs031180173

Contact for Scientific Queries	Name	Kuwabara Satoshi
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana Chuo-ku, Chiba, Chiba prefecture
	Telephone	+81-43-226-2129
	E-mail	kuwabara-s@faculty.chiba-u.jp
Contact for Public Queries	Name	Shibuya Kazumoto
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana Chuo-ku, Chiba, Chiba prefecture
	Telephone	+81-43-226-2129
	E-mail	kazumoto@net.email.ne.jp

Recruitment status	Complete

Anticipated date of first enrollment		June. 01, 2017
Actual date of first enrollment		July. 07, 2017
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Over 20year old 2) Probable of definite ALS disease by Awaji electrophysiological criteria 3) Subjects provided informed consent.
	Exclusion Criteria	1) Patient without ability to comprehend informed consent 2) Patient with uncompensated medical illness 3) Patient with cardiac disease (myocardial infarction, valvular disease and cardiomyopathy etc.) 4) Patient with arrhythmia (incomplet AV-block and bundle branch block etc.) 5) Patient with sodium channel disorders, like Brugada syndrome 6) Patient already administered anti-arrhythmic drug which prolongs PR interval 7) Pregnant or breast-feeding women 8) Patient with forced vital capacity of< 60% predicted 9) Patient already performed tracheotomy or tube feeding 10) Patient take any other experimental agents 3 months before. 11) Not enough CMAP amplitude in the median nerve to be performed nerve excitability test 12) Patient plan to change medicine which affects nerve excitability 13) Familial ALS 14) Patient who is judged inappropriate for this trail by doctors responsible for this trial
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		amyotrophic lateral sclerosis
Intervention(s)		gradual increase of lacosamide from 100mg to 400mg for 4 weeks
Health Condition(s) Keyword		amyotrophic lateral sclerosis
Intervention(s) Keyword
Health Condition(s) Code		G122
Intervention(s) Code
Primary Outcome(s)		Safety for 5 weeks
Secondary Outcome(s)		nerve excitability fasciculation muscle cramp

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japa, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	Jan. 23, 2019

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Nov. 30, 2020	(this page)	Changes
3	June. 15, 2020	Detail	Changes
2	April. 30, 2020	Detail	Changes
1	Mar. 01, 2019	Detail

List of change history