Unique ID issued by UMIN | UMIN000035784 |
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Receipt number | R000040760 |
Scientific Title | Observational study of changes in q-space Myelin Map (qMM) imaging in MS patients treated with dimethyl fumarate (DMF) |
Date of disclosure of the study information | 2019/02/07 |
Last modified on | 2019/08/09 14:34:57 |
Observational study of changes in q-space Myelin Map (qMM) imaging in MS patients
treated with dimethyl fumarate (DMF)
Observational study of changes in q-space Myelin Map (qMM) imaging in MS patients
treated with dimethyl fumarate (DMF)
Observational study of changes in q-space Myelin Map (qMM) imaging in MS patients
treated with dimethyl fumarate (DMF)
Observational study of changes in q-space Myelin Map (qMM) imaging in MS patients
treated with dimethyl fumarate (DMF)
Japan |
Multiple Sclerosis (MS)
Neurology | Radiology |
Others
NO
Primary objective: To characterize changes in qMM recovery in MS patients treated with
DMF.
Secondary objective: To compare changes in lesion qMM with changes in lesion MTR
(magnetization transfer ratio).
Additional objective: To explore possible association between qMM recovery/worsening
and changes in brain atrophy, lesion MTR and physical disability in this study population.
Others
To characterize changes in qMM recovery in MS patients treated with DMF, and to
compare changes in lesion qMM with changes in lesion MTR
Exploratory
Pragmatic
Phase IV
Changes in qMM
Changes in MTR
Observational
20 | years-old | <= |
60 | years-old | >= |
Male and Female
Patient aged from 20 to 60 at the time of consent.
Must have a diagnosis of RRMS as defined by 2010 revised McDonald criteria.
Must have visible evidence of at least one lesion with qMM worsening signal at baseline.
Consented to allow their clinical data entered in the clinical database to be used for research purposes
Concomitant diagnosis of non-MS diseases including cerebral infarction or others that in the opinion of the Investigator would jeopardize the qMM analysis of MS lesions.
Diagnosis or history of neuromyelitis optica (NMO), e.g., a long spinal lesion extending
over 3 or more vertebral bodies was detected, or the subject has a history of positive tests
for anti-aquaporin 4 (anti-AQP4) antibodies.
Not consented or refused to allow their clinical data to be used research purpose.
50
1st name | Jin |
Middle name | |
Last name | Nakahara |
Keio University School of Medicine
Department of Neurology
160-8582
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
03-3353-1211
nakahara@a6.keio.jp
1st name | Jin |
Middle name | |
Last name | Nakahara |
Keio University School of Medicine
Department of Neurology
160-8582
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
03-3353-1211
nakahara@a6.keio.jp
Keio University School of Medicine,
Department of Neurology
Biogen Japan Ltd.
CNS Medical
Profit organization
Japan
Biogen Japan Ltd.
Biogen Inc.
Keio University School of Medicine Ethics Committee
35 Shinanomachi, Shinjuku-ku, Tokyo
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
NO
慶応義塾大学病院(東京都)/Keio University Hospital (Tokyo)
2019 | Year | 02 | Month | 07 | Day |
Unpublished
Open public recruiting
2017 | Year | 08 | Month | 30 | Day |
2018 | Year | 06 | Month | 18 | Day |
2019 | Year | 02 | Month | 01 | Day |
2021 | Year | 03 | Month | 21 | Day |
2022 | Year | 06 | Month | 30 | Day |
This is an open label, prospective study in MS patients who will be initiated the treatment of DMF.
2019 | Year | 02 | Month | 06 | Day |
2019 | Year | 08 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040760
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