- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01305837
Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis (COMTiMS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- Scleroseklinikken, Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: methylprednisolone
all patients will be treated with the active drug methylprednisolone 500 mg in 3 days every month for 60 weeks.
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500 mg of methylprednisolone taken in 3 days every month
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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CSF osteopontin
Time Frame: baseline and week 60
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baseline and week 60
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
aims for clinical progression
Time Frame: baseline and week 60
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baseline and week 60
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aims for demyelination and disease activity
Time Frame: baseline, week 12 (only MRI aims and MEP) and week 60
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1. Change in the concentration of neurofilament heavy chain (NfH) in CSF 2. Change in the concentration of myelin basic protein (MBP) i CSF 3. Change in normalised brain volume (NBV), grey matter volume (GMV) og white matter volume (WMV) 4. Change in MTR og DTI i hele hjernen, lesions, normal appearing grey matter (NAGM) og normal appearing white matter (NAWM) 5. MEP (motor evoked potentials)
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baseline, week 12 (only MRI aims and MEP) and week 60
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aims of intrathecal inflammation
Time Frame: baseline and week 60
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baseline and week 60
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safety
Time Frame: screnning, baseline, week 12, 24, 36, 48, 60
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physical examination, blood pressure, pulse, DEXA scan, bloodtests
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screnning, baseline, week 12, 24, 36, 48, 60
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rikke Ratzer, MD, Scleroseklinikken, Rigshospitalet
- Study Chair: Per S Sørensen, Professor, MD, Scleroseklinikken, Rigshospitalet
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Multiple Sclerosis, Chronic Progressive
- Sclerosis
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- 2010-370
- 2010-024561-43 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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