UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011822 |
|---|---|
| Receipt number | R000013817 |
| Scientific Title | Characterization of Features on MRI findings of Neuromyelitis Optica (NMO) |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2020/09/25 09:38:34 |
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Basic information
Public title
Characterization of Features on MRI findings of Neuromyelitis Optica (NMO)
Acronym
Characterization of Features on MRI findings of Neuromyelitis Optica (NMO)
Scientific Title
Characterization of Features on MRI findings of Neuromyelitis Optica (NMO)
Scientific Title:Acronym
Characterization of Features on MRI findings of Neuromyelitis Optica (NMO)
Region
| Japan |
Condition
Condition
Neuromyelitis Optica (NMO)
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine MR findings of the optic nerves, spinal cord, and brain in NMO patients and determine the characteristic features of NMO by comparing them with MR findings of the optic nerves, spinal cord, and brain in MS patients.
Basic objectives2
Others
Basic objectives -Others
Contribution to the differential diagnosis of NMO and MS
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Descriptive assessments of lesions in the optic nerves, spinal cord, and brain in terms of distribution, frequency, and nature in the NMO group and in the MS group.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
NMO (including NMO spectrum disorder) and MS patients who underwent MRI examination(>1.5T) from April 1,2008 by March 31, 2013
Key exclusion criteria
Patients judged by the (sub-) investigator to be ineligible as a study subject
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Miki |
Organization
Osaka City University
Division name
Radiology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka ,545-0051, JAPAN
TEL
06-6645-3831
yukio.miki@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Miki |
Organization
Osaka City University
Division name
Radiology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka ,545-0051, JAPAN
TEL
06-6645-3831
Homepage URL
yukio.miki@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Inc.
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
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
| 2013 | Year | 10 | Month | 01 | 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
| 2013 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NMO is relatively prevalent in East Asia, including Japan, and magnetic resonance (MR) findings of NMO have been reported in Japan and South Korea. However, almost all reports thus far published are nothing but compilations of a relatively small number of cases at a single center.
Management information
Registered date
| 2013 | Year | 09 | Month | 20 | Day |
Last modified on
| 2020 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013817
