UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035784
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

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Basic information

Public title

Observational study of changes in q-space Myelin Map (qMM) imaging in MS patients
treated with dimethyl fumarate (DMF)

Acronym

Observational study of changes in q-space Myelin Map (qMM) imaging in MS patients
treated with dimethyl fumarate (DMF)

Scientific Title

Observational study of changes in q-space Myelin Map (qMM) imaging in MS patients
treated with dimethyl fumarate (DMF)

Scientific Title:Acronym

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

1st name Jin
Middle name
Last name Nakahara

Organization

Keio University School of Medicine

Division name

Department of Neurology

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582

TEL

03-3353-1211

Email

nakahara@a6.keio.jp


Public contact

Name of contact person

1st name Jin
Middle name
Last name Nakahara

Organization

Keio University School of Medicine

Division name

Department of Neurology

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582

TEL

03-3353-1211

Homepage URL


Email

nakahara@a6.keio.jp


Sponsor or person

Institute

Keio University School of Medicine,
Department of Neurology

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization

Keio University School of Medicine Ethics Committee

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.jp


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


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

Open public recruiting

Date of protocol fixation

2017 Year 08 Month 30 Day

Date of IRB

2018 Year 06 Month 18 Day

Anticipated trial start date

2019 Year 02 Month 01 Day

Last follow-up date

2021 Year 03 Month 21 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2022 Year 06 Month 30 Day


Other

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 08 Month 09 Day



Link to view the page

Value
https://center6.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