UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006423 |
|---|---|
| Receipt number | R000007625 |
| Scientific Title | The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosis |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2015/11/08 12:18:02 |
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Basic information
Public title
The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosis
Acronym
Mexiletine on amyotrophic lateral sclerosis
Scientific Title
The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosis
Scientific Title:Acronym
Mexiletine on amyotrophic lateral sclerosis
Region
| Japan |
Condition
Condition
amyotrophic lateral sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of mexiletine for amyotrophic lateral sclerosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The reduction of ALS Functional Rating Scale Revised
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of mexiletine and riluzole
Interventions/Control_2
administration of riluzole only
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 years old.
2)Patient had probable or definite ALS disease, as defined in the Awaji electrophysiological criteria.
3)Subjects provided informed consent.
Key exclusion criteria
1)Patient did not have ability to comprehend informed consent
2)Patient had uncompensated medical illness
3)Patient had cardiac disease (myocardial infarction, valvular disease and cardiomyopathy etc.)
4)Patient had arrhythmia (incomplet AV-block and bundle branch block etc.)
5)Significant sinus bradycardia 6)Hypotension
7)Hypokalemia
8)Patient already administered anti-arrhythmic drug
9)Woman is pregnant or is breast-feeding
10)Subjects had forced vital capacity of< 60% predicted
11)Subjects were not allowed to take any other experimental agents 3 months before.
12)Subjects had concomitant disease effects peripheral nerve (diabetic peripheral neuropathy, hyperglycemia, ypercapnia etc.)
13)Not evoled CMAP amplitude in median nerve
14)Patient already performed tracheotomy or tube feeding.
15)Patient with disease duration of less than 36 months at study entry.
16)Patient had family history of amyotorphic lateral sclerosis.
17)Patient already administered other drug (procaine amide, quinidine, aprindine, amoxapine, antiepileptic drug). If patient suspend the administration of these drugs, they had possibility to exacerbate illness.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kuwabara |
Organization
Graduate School of Medicine, Chiba University, Japan.
Division name
Department of Neurology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, 260-8670, Japan
TEL
0432262129
kuwabara-s@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumoto Shibuya |
Organization
Graduate School of Medicine, Chiba University, Japan.
Division name
Department of Neurology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, 260-8670, Japan
TEL
0432262129
Homepage URL
kazumoto@net.email.ne.jp
Sponsor or person
Institute
Department of Neurology, Graduate School of Medicine, Chiba University, Japan.
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 28 | Day |
Last modified on
| 2015 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007625
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
