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Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis (COMTiMS)

Primary Purpose

Progressive Multiple Sclerosis

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

methylprednisolone

About this trial

This is an interventional treatment trial for Progressive Multiple Sclerosis focused on measuring multiple sclerosis, methylprednisolone, osteopontin, inflammation, demyelinating

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Scleroseklinikken, Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

methylprednisolone

Arm Description

all patients will be treated with the active drug methylprednisolone 500 mg in 3 days every month for 60 weeks.

Outcomes

Primary Outcome Measures

CSF osteopontin

Secondary Outcome Measures

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)

aims for demyelination and disease activity

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)

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

safety

physical examination, blood pressure, pulse, DEXA scan, bloodtests

Full Information

NCT ID

NCT01305837

First Posted

February 28, 2011

Last Updated

July 10, 2013

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT01305837

Brief Title

Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis

Acronym

COMTiMS

Official Title

Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Progressive Multiple Sclerosis

Keywords

multiple sclerosis, methylprednisolone, osteopontin, inflammation, demyelinating

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

methylprednisolone

Arm Type

Experimental

Arm Description

all patients will be treated with the active drug methylprednisolone 500 mg in 3 days every month for 60 weeks.

Intervention Type

Drug

Intervention Name(s)

methylprednisolone

Other Intervention Name(s)

Medrol

Intervention Description

500 mg of methylprednisolone taken in 3 days every month

Primary Outcome Measure Information:

Title

CSF osteopontin

Time Frame

baseline and week 60

Secondary Outcome Measure Information:

Title

aims for clinical progression

Description

Time Frame

baseline and week 60

Title

aims for demyelination and disease activity

Description

Time Frame

baseline, week 12 (only MRI aims and MEP) and week 60

Title

aims of intrathecal inflammation

Description

Time Frame

baseline and week 60

Title

safety

Description

physical examination, blood pressure, pulse, DEXA scan, bloodtests

Time Frame

screnning, baseline, week 12, 24, 36, 48, 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rikke Ratzer, MD

Organizational Affiliation

Scleroseklinikken, Rigshospitalet

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Per S Sørensen, Professor, MD

Organizational Affiliation

Scleroseklinikken, Rigshospitalet

Official's Role

Study Chair

Facility Information:

Facility Name

Scleroseklinikken, Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

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Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis

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