NCT01077466

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

1.8 years

First QC Date

February 26, 2010

Last Update Submit

February 15, 2012

Conditions

Primary Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis

Keywords

Primary Progressive Multiple SclerosisSecondary Progressive Multiple SclerosisNatalizumabTreatmentSafetyEfficacyCerebrospinal fluidOsteopontin

Outcome Measures

Primary Outcomes (1)

  • Cerebrospinal fluid (CSF) osteopontin

    The primary endpoint is change in CSF osteopontin from baseline to week 60.

    Change from baseline to week 60

Secondary Outcomes (19)

  • Expanded disability status scale (EDSS)

    Baseline to week 60

  • Timed 25-foot Walk (T25FW)

    Baseline to week 60

  • Multiple Sclerosis Impairment Score (MSIS)

    Baseline to week 60

  • Multiple Sclerosis Functional Composite

    Baseline to week 60

  • Short Form 36 Health Survey (SF36)

    Baseline to week 60

  • +14 more secondary outcomes

Study Arms (1)

Natalizumab

EXPERIMENTAL

24 patients: 12 with secondary progressive multiple sclerosis 12 with primary progressive multiple sclerosis

Drug: Natalizumab

Interventions

NatalizumabDRUG

300 mg Natalizumab IV for every 4 week for 56 weeks (15 doses for every patient)

Also known as: Tysabri
Natalizumab

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy, breast-feeding or lack of anti.conception for fertile women.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Multiple Sclerosis Center, Section 2082, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Finn Sellebjerg, MD PhD DMSc

    Danish Multiple Sclerosis Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. professor, MD, PhD, DMSci, Finn Sellebjerg

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 1, 2010

Study Start

March 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations

DK(1)