Natalizumab Treatment of Progressive Multiple Sclerosis
Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Progressive Multiple Sclerosis; Secondary Progressive Multiple Sclerosis
Intervention: Natalizumab (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Rigshospitalet, Denmark Official(s) and/or principal investigator(s): Finn Sellebjerg, MD PhD DMSc, Principal Investigator, Affiliation: Danish Multiple Sclerosis Center
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). Safety measures further includes
physical and neurological examination,blood samples and MRI measures of disease activity.
Clinical Details
Official title: Natalizumab Treatment of Progressive Multiple Sclerosis
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cerebrospinal fluid (CSF) osteopontin
Secondary outcome: Expanded disability status scale (EDSS)Timed 25-foot Walk (T25FW) Multiple Sclerosis Impairment Score (MSIS) Multiple Sclerosis Functional Composite Short Form 36 Health Survey (SF36) CSF Neurofilament Heavy Chain CSF Myelin Basic Protein Atrophy Magnetization transfer ratio (MTR) Diffusion transfer imaging (DTI) CSF cell count Change in IgG-index CSF nitrogen oxide metabolites CSF-serum albumine concentration quotient CSF CXCL13 Matrix metalloproteinase-9 (MMP-9) New Gadolinium-enhancing lesions (GdEL) Volume of lesions on T2-weighted MRI images Number of new or enlarging lesions on T2-weighted MRI images
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.
Eligibility
Minimum age: 19 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Locations and Contacts
Danish Multiple Sclerosis Center, Section 2082, Rigshospitalet, Copenhagen 2100, Denmark
Additional Information
Starting date: March 2010
Last updated: February 15, 2012
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