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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 December 2017 |
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Main ID: |
NCT03193086 |
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Date of registration:
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14/06/2017 |
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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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The Effect of Alemtuzumab on the Blood-brain-barrier and the Brain's Metabolism in Multiple Sclerosis Patients
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Scientific title:
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The Effect of Alemtuzumab on the Blood-brain-barrier and Cerebral Metabolism in Multiple Sclerosis Patients; a New MRI Method for Treatment Response Evaluation in Multiple Sclerosis |
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Date of first enrolment:
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January 1, 2017 |
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Target sample size:
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35 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03193086 |
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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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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Henrik BW Larsson, MD, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Functional Imaging Unit, Department of Clinical Physiology, Nuclear medicine and PET, Glostrup Hospital |
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Name:
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Peter F Svane, MD |
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Address:
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Telephone:
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93906653 |
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Email:
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peter.frederiksen.svane@hotmail.com |
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Affiliation:
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Name:
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Peter F Svane, MD |
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Address:
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Telephone:
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93906653 |
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Email:
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peter.frederiksen.svane@regionh.dk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A diagnosis of Relapsing-Remitting Multiple Sclerosis
- Eligible for alemtuzumab treatment at Glostrup Hospital or The Danish Kingdom Hospital
- Subjects must be deemed physically and mentally able to participate in the study
Exclusion Criteria:
- Contraindications to MRI scanning (pregnancy, pacemakers, claustrophobia, extreme
obesity)
- Contraindications to the use of MRI contrast agents (kidney disease, previous allergic
reactions)
- Conflicting disorders (e.g. disorders with a systemic, inflammatory component)
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Alemtuzumab
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Primary Outcome(s)
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Blood-Brain-Barrier Permeability
[Time Frame: 1 year]
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Secondary Outcome(s)
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Cerebral perfusion
[Time Frame: 1 year]
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Relapse frequency
[Time Frame: 1 year]
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Brain atrophy
[Time Frame: 2 years]
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Urinary markers of inflammation
[Time Frame: 1 year]
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Oxygen Consumption
[Time Frame: 1 year]
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Plasma markers of Blood-Brain-Barrier breakdown
[Time Frame: 1 year]
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Diffusion Tensor MRI parameters and MR spectroscopy metabolite concentrations
[Time Frame: 1 year]
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Plasma markers of neuronal damage
[Time Frame: 1 year]
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Clinical Severity of Disease
[Time Frame: 1 year]
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Secondary ID(s)
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GZ-2016-11629
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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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