UMIN-CTR Clinical Trial

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
Email	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
Email	yukio.miki@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013817