UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050955 |
|---|---|
| Receipt number | R000058082 |
| Scientific Title | Post-marketing surveillance of free radical scavenger, oral edaravone, for the treatment of Amyotrophic Lateral Sclerosis |
| Date of disclosure of the study information | 2023/05/15 |
| Last modified on | 2023/05/15 13:52:54 |
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Basic information
Public title
Post-marketing surveillance of free radical scavenger, oral edaravone, for the treatment of Amyotrophic Lateral Sclerosis
Acronym
Post-marketing surveillance of free radical scavenger, oral edaravone, for the treatment of Amyotrophic Lateral Sclerosis
Scientific Title
Post-marketing surveillance of free radical scavenger, oral edaravone, for the treatment of Amyotrophic Lateral Sclerosis
Scientific Title:Acronym
Post-marketing surveillance of free radical scavenger, oral edaravone, for the treatment of Amyotrophic Lateral Sclerosis
Region
| Japan |
Condition
Condition
Amyotrophic Lateral Sclerosis (ALS)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Drug Use-Results Survey will be conducted with an objective to collect and evaluate information with regard to the safety under the actual drug use in ALS patients who receive treatment with RADICUT (edaravone) oral suspension 2.1%.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
<Analysis items>
1. Types and incidences of adverse drug reactions
2. Incidence of adverse drug reactions by patient characteristics
3. Incidence of serious adverse events
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
ALS patients who receive an edaravone product for the first time
Key exclusion criteria
ALS patients who meet contraindications to the use of edaravone
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Yoshihide |
| Middle name | |
| Last name | Nogami |
Organization
Mitsubishi Tanabe Pharma Corporation
Division name
Global Pharmacovigilance Department
Zip code
541-8505
Address
3-2-10, Dosho-machi, Chuo-ku, Osaka, Japan
TEL
06-6205-5223
nogami.yoshihide@ma.mt-pharma.co.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Ueba |
Organization
Mitsubishi Tanabe Pharma Corporation
Division name
Global Pharmacovigilance Department
Zip code
100-8205
Address
1-1-1, Marunouchi, Chiyoda-ku, Tokyo, Japan
TEL
03-6743-7733
Homepage URL
MTPC-PV-Radicut@ml.mt-pharma.co.jp
Sponsor or person
Institute
Mitsubishi Tanabe Pharma Corporation
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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
| 2023 | Year | 05 | Month | 15 | 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
| 2023 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
General drug use-results survey
Management information
Registered date
| 2023 | Year | 04 | Month | 28 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058082
| 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 |
