Natalizumab Treatment of Progressive Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01077466
• Date of registration: 26/02/2010
• Primary sponsor: Rigshospitalet, Denmark
• Public title: Natalizumab Treatment of Progressive Multiple Sclerosis NAPMS
• Scientific title: Natalizumab Treatment of Progressive Multiple Sclerosis
• Date of first enrolment: March 2010
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01077466
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Denmark

Contacts

• Name: Finn Sellebjerg, MD PhD DMSc
• Affiliation: Danish Multiple Sclerosis Center

Key inclusion & exclusion 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
- 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.



Age minimum: 19 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Progressive Multiple Sclerosis

Secondary Progressive Multiple Sclerosis

Intervention(s)

Drug: Natalizumab

Primary Outcome(s)

Cerebrospinal fluid (CSF) osteopontin [Time Frame: Change from baseline to week 60]

Secondary Outcome(s)

Atrophy [Time Frame: Week 12 to week 60]

Change in IgG-index [Time Frame: Baseline to week 60]

CSF cell count [Time Frame: Baseline to week 60]

CSF CXCL13 [Time Frame: Baseline to week 60]

CSF Myelin Basic Protein [Time Frame: Baseline to week 60]

CSF Neurofilament Heavy Chain [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]

Diffusion transfer imaging (DTI) [Time Frame: Baseline to week 60]

Expanded disability status scale (EDSS) [Time Frame: Baseline to week 60]

Magnetization transfer ratio (MTR) [Time Frame: Baseline to week 60]

Matrix metalloproteinase-9 (MMP-9) [Time Frame: Baseline to week 60]

Multiple Sclerosis Functional Composite [Time Frame: Baseline to week 60]

Multiple Sclerosis Impairment Score (MSIS) [Time Frame: Baseline to week 60]

New Gadolinium-enhancing lesions (GdEL) [Time Frame: Baseline to week 60]

Number of new or enlarging lesions on T2-weighted MRI images [Time Frame: Baseline to week 60]

Short Form 36 Health Survey (SF36) [Time Frame: Baseline to week 60]

Timed 25-foot Walk (T25FW) [Time Frame: Baseline to week 60]

Volume of lesions on T2-weighted MRI images [Time Frame: Baseline to week 60]

Secondary ID(s)

NAPMS version 3.4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biogen Idec

Copenhagen University Hospital, Hvidovre

Signifikans ApS

University of Copenhagen