Trial record 5 of 202 for:    Cerebral Atrophy

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo
ClinicalTrials.gov Identifier:
NCT01847287
First received: May 1, 2013
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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
Multiple Sclerosis

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Evaluation of MRI images from baseline in comparison with a 5 year MRI.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    To evaluate any effect of the number of Tysabri cycles on lesion volume.


Enrollment: 60
Study Start Date: May 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tysabri
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Multiple Sclerosis - relapsing remitting

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847287

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

No publications provided

Responsible Party: Robert Zivadinov, MD, PhD, Director, Buffalo Neuroimaging Analysis Center, Professor, University at Buffalo
ClinicalTrials.gov Identifier: NCT01847287     History of Changes
Other Study ID Numbers: TST5
Study First Received: May 1, 2013
Last Updated: May 6, 2013
Health Authority: USA: SUNY University at Buffalo Health Sciences Review Board

Keywords provided by University at Buffalo:
Multiple sclerosis
Tysabri
MRI
Natalizumab

Additional relevant MeSH terms:
Atrophy
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 24, 2014