Trial record 5 of 200 for:    Cerebral Atrophy

A Longitudinal Study of Brain Atrophy in MS Patients Over 5 Years (TST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01847287
Recruitment Status : Completed
First Posted : May 6, 2013
Last Update Posted : May 7, 2013
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo

Brief Summary:
The primary aim of this study is to evaluate the effect of using Tysabri on changes in the brain using MRI and on disease progression in patients with relapsing-remitting Multiple Sclerosis over 5 years.

Condition or disease
Multiple Sclerosis

Detailed Description:
This is a prospective, observational, single-blinded, longitudinal study of natalizumab effect on brain atrophy development and disability progression in multiple sclerosis patients over 5 years, which will evaluate originally treated patients with natalizumab who participated in a prospective 1- and 2-year VWMTR study. (Zivadinov et al., 2011b) All subjects will be assessed at 5-year follow-up with the same clinical examinations and will obtain 1.5T MRI examination on the same scanner that did not undergo any upgrade changes in the period of 5 years.

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Observational, Single-blinded, Longitudinal Study of Natalizumab Effect on Brain Atrophy and Disability in Multiple Sclerosis Patients Over 5 Years.
Study Start Date : May 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab
U.S. FDA Resources

All subjects took Tysabri and also had an MRI which we use for the baseline evaluation. Over 5 years, some patients remained on Tysabri, some started another drug and others were off Tysabri for a time but then restarted.

Primary Outcome Measures :
  1. The primary aim of this study is to define the effect of the number of natalizumab cycles on development of brain atrophy and progression of disability in originally treated patients with natalizumab in relapsing multiple sclerosis (MS). [ Time Frame: 5 years ]
    Evaluation of MRI images from baseline in comparison with a 5 year MRI.

Secondary Outcome Measures :
  1. The secondary objective of this study is to define the effect of the number of natalizumab cycles on accumulation of T2-LV and T1-LV and their VW-MTR changes over 5 years. [ Time Frame: 5 years ]
    To evaluate any effect of the number of Tysabri cycles on lesion volume.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multiple Sclerosis - relapsing remitting

Inclusion Criteria:

  • Participation in natalizumab 1-year follow-up study
  • Participants were aged 18-65
  • Have clinically definite MS according to the Polman criteria of either RR or RSP disease type
  • EDSS scores ≤6.5
  • disease duration <30 years
  • normal kidney function (creatinine clearance >59 mL/min)
  • started therapy either with natalizumab or IM interferon beta-1a (IFNβ-1a)
  • Signed informed consent
  • Normal kidney functioning (creatinine clearance >59)
  • None of the exclusion criteria

Exclusion Criteria:

  • A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to 5-year follow-up visit
  • Nursing mothers or pregnant women who will need to undergo 5-year follow-up MRI
  • Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
  • Any other reasons that, in the opinion of the Investigator, indicate that the subject is unsuitable for enrollment into this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01847287

United States, New York
Buffalo Neuroimaging Analysis Center
Buffalo, New York, United States, 14203
Sponsors and Collaborators
University at Buffalo

Responsible Party: Robert Zivadinov, MD, PhD, Director, Buffalo Neuroimaging Analysis Center, Professor, University at Buffalo Identifier: NCT01847287     History of Changes
Other Study ID Numbers: TST5
First Posted: May 6, 2013    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013

Keywords provided by Robert Zivadinov, MD, PhD, University at Buffalo:
Multiple sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathological Conditions, Anatomical
Immunologic Factors
Physiological Effects of Drugs