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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023978
Receipt No. 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 2019/04/18

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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
Middle name
Last name Gen Sobue
Organization Nagoya University
Division name Graduate School of Medicine
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL 052-741-2111
Email sobueg@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaoru Ishizaki
Organization Mitshubishi Tanabe Pharma Corporation
Division name Pharmacovigilance Department
Zip code
Address 17-10 Nihonbashi-Koamicyo, Chuo-ku, Tokyo, Japan
TEL 03-6743-7733
Homepage URL
Email Ishizaki.Kaoru@mh.mt-pharma.co.jp

Sponsor
Institute Mitsubishi Tanabe Pharma Cooperation
Institute
Department

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
Address
Tel
Email

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
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.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


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