COMTiMS
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Methylprednisolone
Glucocorticoid receptor agonist
What it measured
Main measures
CSF osteopontin
baseline and week 60
Blood or spinal fluid markers· Ændring i koncentrationen af osteopontin i CSV fra baseline til uge 60.
Other measures (4)
aims for clinical progression
baseline and week 60
Disability progressionWalking and mobilityQuality of life (reported by participants)aims for demyelination and disease activity
baseline, week 12 (only MRI aims and MEP) and week 60
MRI lesionsBrain volume lossBlood or spinal fluid markersMyelin repairNerve conduction testsaims of intrathecal inflammation
baseline and week 60
MRI lesionsBlood or spinal fluid markersMyelin repairsafety
screnning, baseline, week 12, 24, 36, 48, 60
Safety
Who could take part
Progressive MS · 18 to 65
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Apr 2011
Main results due
Jul 2013
Finished
Jul 2013
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