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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2021 |
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Main ID: |
NCT02403570 |
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Date of registration:
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10/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis
ROMUS |
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Scientific title:
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Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02403570 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Finland
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Contacts
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Name:
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Hannu Aronen, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Turku University Hospital, Department of Diagnostic Radiology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The diagnosis of relapsing remitting MS made according to the Poser, McDonald's or
revised McDonald's criteria (Group I) before participating in the study
- Initial MS diagnosis of relapsing remitting form of the disease according to the
criteria as mentioned above, and conversion into the secondary progressive phase of
the disease as evaluated by the referring neurologist according to the clinical
evaluation and confirmed by the study physician (Group II).
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient must sign the appropriate Ethical Committee (EC)
approved informed consent documents in the presence of the designated staff
Exclusion Criteria:
- Any other autoimmune disease than MS requiring immunomodulatory or immunosuppressive
medication
- High-dose corticosteroid treatment within 30 days before participating in the study
- Prior medical history: Patient must have no history of serious cardiovascular, liver
or kidney disease
- Any psychiatric condition that compromises the subject's ability to participate in the
study
- Infections: Patient must not have an uncontrolled serious infection
- No contraindications for MRI (cardiac pacemaker, intracranial clips etc)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis, Relapsing-Remitting
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Multiple Sclerosis, Chronic Progressive
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Multiple Sclerosis
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Intervention(s)
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Other: Brain MRI
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Primary Outcome(s)
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MR relaxation values 0
[Time Frame: Baseline]
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MR relaxation values 1
[Time Frame: One year]
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Secondary Outcome(s)
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MR relaxation values and clinical markers 1
[Time Frame: One year]
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MR relaxation values and clinical markers 0
[Time Frame: Baseline]
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Secondary ID(s)
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T125/2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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