UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047103 |
|---|---|
| Receipt number | R000053732 |
| Scientific Title | Analysis and clearing the real clinical neurological relentless disease. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/03/07 13:00:45 |
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Basic information
Public title
Analysis and clearing the real clinical neurological relentless disease.
Acronym
Analysis and clearing the real clinical neurological relentless disease.
Scientific Title
Analysis and clearing the real clinical neurological relentless disease.
Scientific Title:Acronym
Analysis and clearing the real clinical neurological relentless disease.
Region
| Japan |
Condition
Condition
Distal myopathy, SBMA, ALS, Crow-Fukase syndrome, PLS, Myopathy with rimmed vacuoles, CMT, MG, PSP, PML, SCD, MSA, CBD, MS, NMO, PD, CIDP, MMN, Moyamoya disease, Alexander disease, muscle dystrophy, AERRPS, fragile X syndrome, TIA, or ischemic stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We registered the neurological relentless disease patient medical treatment data into the database and clearing the clinical actuality.
Basic objectives2
Others
Basic objectives -Others
Actual prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Drug information, mRS, cardiovascular event, and mortality at 6M, 12M, 24M, 36M, 48M, and 60M after registration.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Distal myopathy SBMA, ALS, Crow-Fukase syndrome, PLS, rimmed vacuole myopathy, CMT, MG, PDP, PML, SCD, MSA, CBD, MS, NMO, PD, CIDP, MMN, Moyamoya disease, AERRPS, fragile X syndrome, TIA, or ischemic stroke diagnosed patient.
Key exclusion criteria
MRI impossible patient.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Fujimoto |
Organization
Jichi Medical University
Division name
Division of Neurology, Department of Medicine
Zip code
329-0498
Address
Yakushiji 3311-1, Shimotsuke, Tochigi
TEL
0285587352
shigeruf830@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Matsuzono |
Organization
Jichi Medical University
Division name
Division of Neurology, Department of Medicine
Zip code
329-0498
Address
Yakushiji 3311-1, Shimotsuke, Tochigi
TEL
0285587352
Homepage URL
kmatsuzono51@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University
Address
Yakushiji 3311-1, Shimotsuke, Tochigi
Tel
0285587352
jichi@esct.bvits.com
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
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2037 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
One-hundred eighty six patients have been participated in this study at March 31th 2021.
Management information
Registered date
| 2022 | Year | 03 | Month | 07 | Day |
Last modified on
| 2022 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053732
