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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035784
Receipt No. R000040760
Official scientific title of the study 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 2019/02/06

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Basic information
Official scientific title of the study Observational study of changes in q-space Myelin Map (qMM) imaging in MS patients
treated with dimethyl fumarate (DMF)
Title of the study (Brief title) Observational study of changes in q-space Myelin Map (qMM) imaging in MS patients
treated with dimethyl fumarate (DMF)
Region
Japan

Condition
Condition Multiple Sclerosis (MS)
Classification by specialty
Neurology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Others
Basic objectives -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
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Changes in qMM
Key secondary outcomes Changes in MTR

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
60 years-old >=
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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.
Target sample size 50

Research contact person
Name of lead principal investigator Jin Nakahara
Organization Keio University School of Medicine
Division name Department of Neurology
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL 03-3353-1211
Email nakahara@a6.keio.jp

Public contact
Name of contact person Jin Nakahara
Organization Keio University School of Medicine
Division name Department of Neurology
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL 03-3353-1211
Homepage URL
Email nakahara@a6.keio.jp

Sponsor
Institute Keio University School of Medicine,
Department of Neurology
Institute
Department

Funding Source
Organization Biogen Japan Ltd.
CNS Medical
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Biogen Japan Ltd.
Biogen Inc.
Name of secondary funder(s)

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 慶応義塾大学病院(東京都)/Keio University Hospital (Tokyo)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 07 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 08 Month 30 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2022 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information This is an open label, prospective study in MS patients who will be initiated the treatment of DMF.

Management information
Registered date
2019 Year 02 Month 06 Day
Last modified on
2019 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040760

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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