UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023978 |
|---|---|
| Receipt number | R000027562 |
| Scientific Title | Surveillance of Using Novel free Radical scavenger, edaravone to Investigate Survival Effect for ALS patients in Japan |
| Date of disclosure of the study information | 2016/09/15 |
| Last modified on | 2023/10/26 22:23:16 |
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Basic information
Public title
Surveillance of Using Novel free Radical scavenger, edaravone to Investigate Survival Effect for ALS patients in Japan
Acronym
SUNRISE Japan
Scientific Title
Surveillance of Using Novel free Radical scavenger, edaravone to Investigate Survival Effect for ALS patients in Japan
Scientific Title:Acronym
SUNRISE Japan
Region
| Japan |
Condition
Condition
Amyotrophic lateral sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Special Drug Use-Results Survey will be conducted with an objective to collect and evaluate information with regard to the safety and efficacy under the actual drug use and the effect on long-term prognosis in patients who receive a treatment with edaravone for amyotrophic lateral sclerosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset date of death and introduction of permanent artificial ventilation*
*: Introduction of permanent artificial ventilation accompanied with tracheotomy
Key secondary outcomes
1) Onset date of the following events:
- introduction of tube feeding
- gastrostomy
- introduction of intermittent non-invasive ventilatory assistance (e.g. NIPPV)
- tracheotomy
- inability to have a speech
- inability to swallow
- no function of the upper extremities
- inability to walk independently
- inability to turn over independently
2) ALSFRS-R Score
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 (in case of transferred patients, ALS patients who have started the surveillance in the previous institution)
Key exclusion criteria
ALS patients who meet contraindications to the use of edaravone
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Gen |
| Middle name | |
| Last name | Gen Sobue |
Organization
Nagoya University
Division name
Graduate School of Medicine
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL
052-741-2111
sobueg@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Ishizaki |
Organization
Mitshubishi Tanabe Pharma Corporation
Division name
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 Cooperation
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Cooperation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2016 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison to an appropriate external control data will be determined with regard to the efficacy.
Management information
Registered date
| 2016 | Year | 09 | Month | 08 | Day |
Last modified on
| 2023 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027562
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
