Progressive Multiple SclerosisPhase 2COMTiMSNCT01305837
Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis
A Phase 2 study testing methylprednisolone in people with Progressive Multiple Sclerosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Progressive Multiple Sclerosis
- What is being tested?
- methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Progressive Multiple Sclerosis
- Being tested
- methylprednisolone
- Keywords
- multiple sclerosis, methylprednisolone, osteopontin, inflammation, demyelinating
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Medrol
500 mg of methylprednisolone taken in 3 days every month
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone | Experimental | all patients will be treated with the active drug methylprednisolone 500 mg in 3 days every month for 60 weeks. Receives: Drug: methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF osteopontin
Measured: baseline and week 60
Secondary outcomes (4)
aims for clinical progression
- Change in expanded disability status scale (EDSS)
- Change in Timed 25-foot Walk (T25FW)
- Change in Multiple sclerosis impairment scale (MSIS)
- Change in multiple sclerosis functional composite (MSFC)
- Change in short form 36 (SF-36)
Measured: baseline and week 60
aims for demyelination and disease activity
- 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)
Measured: baseline, week 12 (only MRI aims and MEP) and week 60
aims of intrathecal inflammation
- Change in cellcount i CSF
- Change in IgG-index
- Change in the concentration of nitric oxid (NO) metabolittes in CSV
- Change in CSV-serum albumin qvotient
- Change in the concentration of CXCL13 i CSF
- Change in the concentration of MMP-9 i CSF
- Number of new Gd-enhancing lessions on MRI
- Volume of T2 lessions on MRI
- Number of new or bigger T2 lessions on
- Change in MTR in the hole brain, in lessions, grey matter og white matter
- Change in DTI the hole brain, in lessions, grey matter og white matter
Measured: baseline and week 60
safety
physical examination, blood pressure, pulse, DEXA scan, bloodtests
Measured: screnning, baseline, week 12, 24, 36, 48, 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikke Ratzer, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Rikke Ratzer, MD, Principal investigator, Scleroseklinikken, RigshospitaletPer S Sørensen, Professor, MD, Study chair, Scleroseklinikken, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305837
- Sponsor's protocol ID
- 2010-370
- Other IDs
- 2010-024561-43
- Acronym
- COMTiMS
- Status last verified
- Jul 2013
- First submitted
- 28 Feb 2011
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01305837
- Acronym / sponsor ID
- COMTiMS / 2010-370
- Conditions
- Progressive Multiple Sclerosis
- Keywords
- multiple sclerosis, methylprednisolone, osteopontin, inflammation, demyelinating
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone | Experimental | Drug: methylprednisoloneall patients will be treated with the active drug methylprednisolone 500 mg in 3 days every month for 60 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylprednisoloneAlso: Medrol500 mg of methylprednisolone taken in 3 days every month | Drug | methylprednisolone |
Primary outcome
CSF osteopontin
Time frame: baseline and week 60
4 secondary outcomes
aims for clinical progression
Time frame: baseline and week 60
aims for demyelination and disease activity
Time frame: baseline, week 12 (only MRI aims and MEP) and week 60
aims of intrathecal inflammation
Time frame: baseline and week 60
safety
Time frame: screnning, baseline, week 12, 24, 36, 48, 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rikke Ratzer, MD principal investigator
Scleroseklinikken, Rigshospitalet
Per S Sørensen, Professor, MD study chair
Scleroseklinikken, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing methylprednisolone in people with Progressive Multiple Sclerosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF osteopontin (time frame: baseline and week 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.