Progressive Multiple Sclerosis Clinical Trial
Official title:
Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis
The purpose of this study is to determine whether cyclic oral methylprednisolone once every month has an effect on the intrathecal inflammation in patients suffering from progressive multiple sclerosis.
Multiple Sclerosis (MS) is a chronic inflammatory demyelinating disease of the central
nervous system (CNS). It is presumably T-cell mediated and it is the most common
non-traumatic cause of disability affecting young people. 85 % of the MS causes starts out
as relapsing remitting MS (RRMS) and 15 % as primary progressive MS (PPMS). It has been
found that after 10 years 40-45 % of the RRMS patients will convert to a more progressive
state of disease, secondary progressive MS (SPMS).
Until recently it has been believed that the progression seen in MS occurred because of
axonal loss and neurodegeneration could occur independently of inflammation. Now
neuropathology studies shows that there is a close association between inflammation and
neurodegeneration in all stages of MS - also the progressive forms of MS.
Osteopontin (OPN) is an extracellular matrix protein with chemokine, cytokine and intergrin
properties. It has multiple immunological functions and is secreted by activated
macrophages, leukocytes and activated T lymphocytes. It is present in extracellular fluids
and is up-regulated at sites of inflammation. Increased levels of OPN where reported in the
cerebrospinal fluid (CSF) in patients with MS.
The main aim of this study is to analyze the effect of cyclic oral methylprednisolone on the
intrathecal inflammation in patients suffering from progressive multiple sclerosis measured
by OPN in the CSF. Second the investigators will look at other aims of intrathecal
inflammation, neurodegeneration, demyelination and safety.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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