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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)

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000035784
Enrollment
50
Registered
2019-02-07
Start date
2019-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis (MS)

Interventions

None listed

Sponsors

Keio University School of Medicine, Department of Neurology
Lead Sponsor
Biogen Japan Ltd. Biogen Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Changes in qMM

Secondary

MeasureTime frame
Changes in MTR

Countries

Japan

Contacts

Public ContactJin Nakahara

Keio University School of Medicine Department of Neurology

nakahara@a6.keio.jp03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026