Status unknownRelapsing MSNCT03193086

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

What it measured

Main measures

  • Blood-Brain-Barrier Permeability

    1 year

    MRI lesions

Other measures (9)

  • Oxygen Consumption

    1 year

    MRI lesions
  • Cerebral perfusion

    1 year

    MRI lesions
  • Diffusion Tensor MRI parameters and MR spectroscopy metabolite concentrations

    1 year

    MRI lesions
  • Brain atrophy

    2 years

    MRI lesionsBrain volume loss
  • Clinical Severity of Disease

    1 year

    Disability progression
  • Relapse frequency

    1 year

    Relapses
  • Plasma markers of Blood-Brain-Barrier breakdown

    1 year

  • Plasma markers of neuronal damage

    1 year

  • Urinary markers of inflammation

    1 year

    Smouldering inflammationBladder, bowel and sexual function

Who could take part

Relapsing MS · 18 to 60

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)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The development and progression of multiple sclerosis seem to be driven by concomitant inflammation and, to a less well-defined degree, disturbances in metabolism of individual cells of the human central nervous system as well as changes in the dynamical supply of blood to the brain. These alterations in normal physiology can be quantified by investigating the change in specific parameters over the time course of multiple sclerosis evolution. Amongst these specific parameters, the ability of the so-called blood-brain-barrier to selectively filter nutrients from the blood stream prior to passage into the nervous tissue, is disrupted in multiple sclerosis, and the severity of this deficiency seem to be related to the underlying disease burden. The present study utilises a novel imaging technology in order to monitor changes in the integrity of the blood-brain-barrier over the course of treatment with a biological disease modifying agent known as alemtuzumab. Alemtuzumab is a potent immunosuppressant drug. It is hypothesised that alemtuzumab reverts the deficiency in blood-brain-barrier integrity and, conversely, the severity of blood-brain-barrier disruption at several time points during alemtuzumab treatment can be utilised as prognostic marker for the requirement of additional administration of alemtuzumab beyond the regular treatment regimen. In addition, several other factors are investigated by advanced imaging techniques in combination with blood and urine samples in order to elucidate the possible underlying mechanism of alemtuzumab efficacy. It is hypothesized that alemtuzumab normalises metabolic alterations and changes in the blood supply through resolution of inflammation in the brains of multiple sclerosis patients.

Papers

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Related trials

History

    1. Started

      Jan 2017

    2. Main results due

      Mar 2020

    3. Finished

      Mar 2020

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