UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027476
Receipt No. R000031479
Scientific Title Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis
Date of disclosure of the study information 2017/06/01
Last modified on 2019/05/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis
Acronym Open-label clinical trial of lacosamide in ALS
Scientific Title Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis
Scientific Title:Acronym Open-label clinical trial of lacosamide in ALS
Region
Japan

Condition
Condition amyotrophic lateral sclerosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Safety
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety for 4 weeks
Key secondary outcomes nerve excitability
fasciculation
muscle cramp

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 gradual increase of lacosamide from 100mg to 400mg for 4 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Over 20 year old
2) Probable of definite ALS disease by Awaji electrophysiological criteria
3) Subjects provided informed consent.
Key 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
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Kuwabara
Organization Chiba University Hospital
Division name Department of Neurology
Zip code 260-8677
Address 1-8-1 Inohana Chuo-ku, Chiba 260-8677 JAPAN
TEL 043-226-2129
Email kuwabara-s@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Kazumoto
Middle name
Last name Shibuya
Organization Chiba University Hospital
Division name Department of Neurology
Zip code 260-8677
Address 1-8-1 Inohana Chuo-ku, Chiba 260-8677 JAPAN
TEL 043-226-2129
Homepage URL
Email kazumoto@net.email.ne.jp

Sponsor
Institute Department of Neurology Chiba University Hospital
Institute
Department

Funding Source
Organization KAKENHI grant
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba University Certified Clinical Research Review Board
Address 1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japa Chiba
Tel 043-226-2616
Email prc-jim@chiba-u.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 05 Month 24 Day
Date of IRB
2019 Year 01 Month 23 Day
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 24 Day
Last modified on
2019 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031479

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.