Primary Progressive Multiple SclerosisPhase 2NAPMSNCT01077466
Natalizumab Treatment of Progressive Multiple Sclerosis
A Phase 2 study testing Natalizumab in people with Primary Progressive Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to study safety and efficacy of natalizumab treatment of primary and secondary progressive multiple sclerosis. This will be done by measuring the effect of treatment on inflammation in the CNS by means of osteopontin levels in the cerebrospinal fluid (CSF). Read more about this study
- Who is it for?
- Ages 19 to 55 years
- Conditions the study is for
- Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
- What is being tested?
- Natalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Jan 2012
- 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 19 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 19 and 55 years
- Progressive disease course of multiple sclerosis (primary or secondary)
- Duration of progressive phase of at least 1 year
- Progression of > 1 EDSS point during the last 2 years (>½ EDSS point if EDSS > 5,5)
- EDSS </= 6.5
- Written and informed consent
Who cannot join
- Pregnancy, breast-feeding or lack of anti.conception for fertile women.
- Attack during the last month before inclusion.
- Treatment with methylprednisolone during 3 months before inclusion.
- Treatment with interferon-beta, glatirameracetate, immunoglobulin G or other immune-modulating treatment 3 months prior to inclusion.
- Treatment with mitoxantrone, cyclophosphamide, azathioprine or other strong immunosuppressive drug 6 months prior to inclusion.
- Prior experimental treatment with strong immunosuppressive drug which the treating physician means will influence the results of the trial.
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- Diseases associated with immunodeficiency.
- Treatment with other anticoagulant than aspirin.
- Current malign disease.
- Diabetes Mellitus or other autoimmune disease.
- Renal insufficiency or creatinine > 150 μmol/l.
- Travel in tropical areas 3 months prior to inclusion.
- Acute or chronic infectious diseases, which the treating physician finds relevant (e.g.hepatitis B virus, hepatitis C virus, HIV).
- Psychiatric disease or other circumstances that may limit the patients participation in the trial.
- Contraindication for MRI scan or gadolinium contrast .
- Known hypersensitivity to natalizumab.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Multiple Sclerosis Center, Section 2082, Rigshospitalet
Copenhagen, 2100
About this study
The purpose of this study is to study safety and efficacy of natalizumab treatment of primary and secondary progressive multiple sclerosis.
This will be done by measuring the effect of treatment on inflammation in the CNS by means of osteopontin levels in the cerebrospinal fluid (CSF). Safety measures further includes physical and neurological examination,blood samples and MRI measures of disease activity.
Read the detailed description
The study will include 12 secondary progressive multiple sclerosis patients and 12 primary progressive multiple sclerosis patients to treatment with IV natalizumab for 60 weeks. At baseline and week 60 a lumbar puncture will be performed. MRI scans will be performed at baseline week 12 and week 60.Safety blood samples will be collected every 12 week.
- Being tested
- Natalizumab
- Keywords
- Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Natalizumab, Treatment, Safety, Efficacy, Cerebrospinal fluid, Osteopontin
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatalizumabDrug
Also called Tysabri
300 mg Natalizumab IV for every 4 week for 56 weeks (15 doses for every patient)
| Study group | Role | What they receive |
|---|---|---|
| Natalizumab | Experimental | 24 patients: 12 with secondary progressive multiple sclerosis 12 with primary progressive multiple sclerosis Receives: Drug: Natalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrospinal fluid (CSF) osteopontin
The primary endpoint is change in CSF osteopontin from baseline to week 60.
Measured: Change from baseline to week 60
Secondary outcomes (19)
Expanded disability status scale (EDSS)
Change in expanded disability status scale (EDSS)from baseline to week 60
Measured: Baseline to week 60
Timed 25-foot Walk (T25FW)
Measured: Baseline to week 60
Multiple Sclerosis Impairment Score (MSIS)
Measured: Baseline to week 60
Multiple Sclerosis Functional Composite
Measured: Baseline to week 60
Short Form 36 Health Survey (SF36)
Measured: Baseline to week 60
CSF Neurofilament Heavy Chain
Change in neurofilament heavy chain in the cerebrospinal fluid
Measured: Baseline to week 60
CSF Myelin Basic Protein
Change in myelin basic protein in CSF from baseline to week 60
Measured: Baseline to week 60
Atrophy
Change in normalised brain volume (NBV), grey matter volume (GMV) og white matter volume (WMV) from week 12 to week 60
Measured: Week 12 to week 60
Magnetization transfer ratio (MTR)
Change in MTR in whole brain, lesions, normal-appearing grey matter (NAGM) og normal-appearing white matter (NAWM) from baseline to week 60
Measured: Baseline to week 60
Diffusion transfer imaging (DTI)
Change in FA and ADC in lesions, GM and NAWM between baseline and week 60.
Measured: Baseline to week 60
CSF cell count
Change in CSF cell count from baseline to week 60
Measured: Baseline to week 60
Change in IgG-index
Measured: Baseline to week 60
CSF nitrogen oxide metabolites
Measured: Baseline to week 60
CSF-serum albumine concentration quotient
Measured: Baseline to week 60
CSF CXCL13
Measured: Baseline to week 60
Matrix metalloproteinase-9 (MMP-9)
Measured: Baseline to week 60
New Gadolinium-enhancing lesions (GdEL)
Measured: Baseline to week 60
Volume of lesions on T2-weighted MRI images
Measured: Baseline to week 60
Number of new or enlarging lesions on T2-weighted MRI images
Measured: Baseline to week 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 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, Biogen, University of Copenhagen, Signifikans ApS
- Responsible party
- Principal investigator, Finn Sellebjerg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Finn Sellebjerg, MD PhD DMSc, Principal investigator, Danish Multiple Sclerosis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077466
- Sponsor's protocol ID
- NAPMS version 3.4
- Acronym
- NAPMS
- Status last verified
- Feb 2012
- First submitted
- 26 Feb 2010
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natalizumab Treatment of Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01077466
- Acronym / sponsor ID
- NAPMS / NAPMS version 3.4
- Keywords
- Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Natalizumab, Treatment, Safety, Efficacy, Cerebrospinal fluid, Osteopontin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, Biogen, University of Copenhagen, Signifikans ApS
- Study start
- Mar 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 Mar 2010 (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 study safety and efficacy of natalizumab treatment of primary and secondary progressive multiple sclerosis.
This will be done by measuring the effect of treatment on inflammation in the CNS by means of osteopontin levels in the cerebrospinal fluid (CSF). Safety measures further includes physical and neurological examination,blood samples and MRI measures of disease activity.
Detailed description
The study will include 12 secondary progressive multiple sclerosis patients and 12 primary progressive multiple sclerosis patients to treatment with IV natalizumab for 60 weeks. At baseline and week 60 a lumbar puncture will be performed. MRI scans will be performed at baseline week 12 and week 60.Safety blood samples will be collected every 12 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natalizumab | Experimental | Drug: Natalizumab24 patients: 12 with secondary progressive multiple sclerosis 12 with primary progressive multiple sclerosis |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 19 and 55 years
- Progressive disease course of multiple sclerosis (primary or secondary)
- Duration of progressive phase of at least 1 year
- Progression of > 1 EDSS point during the last 2 years (>½ EDSS point if EDSS > 5,5)
- EDSS </= 6.5
Key exclusion criteria (16 listed)
- Pregnancy, breast-feeding or lack of anti.conception for fertile women.
- Attack during the last month before inclusion.
- Treatment with methylprednisolone during 3 months before inclusion.
- Treatment with interferon-beta, glatirameracetate, immunoglobulin G or other immune-modulating treatment 3 months prior to inclusion.
- Treatment with mitoxantrone, cyclophosphamide, azathioprine or other strong immunosuppressive drug 6 months prior to 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 |
|---|---|---|
| NatalizumabAlso: Tysabri300 mg Natalizumab IV for every 4 week for 56 weeks (15 doses for every patient) | Drug | Natalizumab |
Primary outcome
Cerebrospinal fluid (CSF) osteopontin
Time frame: Change from baseline to week 60
The primary endpoint is change in CSF osteopontin from baseline to week 60.
19 secondary outcomes
Expanded disability status scale (EDSS)
Time frame: Baseline to week 60
Timed 25-foot Walk (T25FW)
Time frame: Baseline to week 60
Multiple Sclerosis Impairment Score (MSIS)
Time frame: Baseline to week 60
Multiple Sclerosis Functional Composite
Time frame: Baseline to week 60
Short Form 36 Health Survey (SF36)
Time frame: Baseline to week 60
CSF Neurofilament Heavy Chain
Time frame: Baseline to week 60
CSF Myelin Basic Protein
Time frame: Baseline to week 60
Atrophy
Time frame: Week 12 to week 60
Magnetization transfer ratio (MTR)
Time frame: Baseline to week 60
Diffusion transfer imaging (DTI)
Time frame: Baseline to week 60
CSF cell count
Time frame: Baseline to week 60
Change in IgG-index
Time frame: Baseline to week 60
CSF nitrogen oxide metabolites
Time frame: Baseline to week 60
CSF-serum albumine concentration quotient
Time frame: Baseline to week 60
CSF CXCL13
Time frame: Baseline to week 60
Matrix metalloproteinase-9 (MMP-9)
Time frame: Baseline to week 60
New Gadolinium-enhancing lesions (GdEL)
Time frame: Baseline to week 60
Volume of lesions on T2-weighted MRI images
Time frame: Baseline to week 60
Number of new or enlarging lesions on T2-weighted MRI images
Time frame: Baseline to week 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 17 Feb 2012.
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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.
Finn Sellebjerg, MD PhD DMSc principal investigator
Danish Multiple Sclerosis Center
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 Natalizumab in people with Primary Progressive Multiple Sclerosis and Secondary 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 6 inclusion and 16 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 17 Feb 2012. 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?
Cerebrospinal fluid (CSF) osteopontin (time frame: Change from baseline to 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 17 Feb 2012.