Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis (COMTiMS)

Rigshospitalet

Status and phase

Completed

Phase 2

Conditions

Progressive Multiple Sclerosis

Treatments

Drug: methylprednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT01305837

2010-370

2010-024561-43 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 and 65 years old
Progressive form of MS (Eg. primary or secondary progressive MS)
Duration of progressive phase at least 1 year
Progression of at least 1 EDSS point for the last 2 years or at least ½ EDSS point in patients with EDSS > 5,5
Progressin in 2 FS point
EDSS </= 6,5
Signed informed consent and written authority

Exclusion criteria

Pregnancy and breast feeding
Lack of secure contraception for women of child-bearing age (hormonal or intrauterine device)
Attack in the last month previous to inclusion
Treatment with methylprednisolone or cyclic methylprednisolone the 3 previous month before inclusion
Treatment with interferon-beta, Glatiramer acetate, immunglobulin G or other immunomodulating treatment the 3 previous month before inclusion
Treatment with Mitoxantrone, ciclofosfamide, Azathioprin or other immunosuppressive treatment the 6 previous month before inclusion
Previous treatment with drugs which the treating physician finds could have influence on the study results
Diseases associated with immune defects
Treatment with other anticoagulant than acetyl salicyl acid
Malignancy
Diabetes Mellitus
Renal insufficiency or S-Creatinine > 150 mmol/l
Acute or chronic infections with hepatitis B og C virus, HIV or other infections which the treating physician finds relevant
Psychiatric illness or other conditions which can impair the collaboration of the patient participating in the study
Contra-indication to MRI
Hypersensitivity to methylprednisolone
Osteoporosis