UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024854 |
|---|---|
| Receipt number | R000028592 |
| Scientific Title | Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis |
| Date of disclosure of the study information | 2016/11/16 |
| Last modified on | 2020/05/19 09:54:09 |
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Basic information
Public title
Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis
Acronym
Clinical study for the anti-oxidative stress by edaravone in ALS
Scientific Title
Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis
Scientific Title:Acronym
Clinical study for the anti-oxidative stress by edaravone in ALS
Region
| Japan |
Condition
Condition
Amyotrophic Lateral Sclerosis (ALS)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effects of anti-oxidative stress of edaravone in ALS patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We evaluate the effects of edaravone for oxidative stress, anti-oxidative stress and vascular endothelial function in ALS patients.
Key secondary outcomes
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
Edaravone treatment for ALS patients
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ALS patients diagnosed as ALS definite, ALS probable, or probable ALS laboratory supported in EI Escorial arranged Airie House diagnosis criteria, with disease duration within 3 years
Key exclusion criteria
Severe renal dysfunction (Cr > 3.0 mg/dl) and impossible evaluations for motor functions
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Abe |
Organization
Okayama university
Division name
Dapartment of Neurology
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7365
yasuyuki@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Ohta |
Organization
Okayama university
Division name
Department of Neurology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7365
Homepage URL
yasuyuki@okayama-u.ac.jp
Sponsor or person
Institute
Okayama university
Institute
Department
Personal name
Funding Source
Organization
Okayama university
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
| 2016 | Year | 11 | Month | 16 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 15 | Day |
Last modified on
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028592
