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Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01071512
First received: February 17, 2010
Last updated: August 4, 2017
Last verified: August 2017
  Purpose
The long-term objective is to further establish the role of Tysabri in preventing neurological degeneration in multiple sclerosis (MS) and to establish powerful and efficient new markers for neurological degeneration in MS. The study intends to correlate cognition with two instruments and their measurements-MRI and OCT (optical coherence tomography).

Condition Intervention
Multiple Sclerosis Drug: Tysabri

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Change in Cognitive Function Over Time [ Time Frame: Baseline, 48 weeks, 96 weeks ]
    Cognitive function was assessed using the oral version of the Symbol Digit Modalities Test (SDMT). The number of correct responses in 90 seconds was recorded (possible range 0-110). For analysis, SDMT scores were converted to z-scores using published age and education based norms. A negative z-score indicates a SDMT score below the mean based on the age and education based norms, for example a z-score of -2 = 2 standard deviations below the mean; a positive z-score indicating a score above the mean. Higher scores indicate better cognitive function.


Secondary Outcome Measures:
  • Change Over Time in Retinal Nerve Fiber Layer Thickness [ Time Frame: Baseline, 24, 48, 72, and 96 weeks ]
    Retinal Nerve Fiber Layer (RNFL) thickness was measured using spectral domain OCT scans by a trained technician. Scans were performed without pupil dilation.

  • Change Over Time in Brain Parenchymal Fraction [ Time Frame: Baseline, 48 weeks, 96 weeks ]
    Measured based on MRI scan on a 3T Phillips scanner. This is a measure of brain atrophy with lower values indicating greater atrophy (possible range 0-1).

  • Change Over Time in Normalized Thalamic Volume [ Time Frame: Baseline, 48 weeks, 96 weeks ]
    Measured on MRI scan

  • Change Over Time in Normalized Hippocampal Volume [ Time Frame: Baseline, 48 weeks, 96 weeks ]
    Measured on MRI scan


Enrollment: 20
Study Start Date: April 2010
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tysabri
Natalizumab 300 mg IV every 4 weeks
Drug: Tysabri
Infuse TYSABRI® 300 mg in 100 mL 0.9% Sodium Chloride Injection, USP over approximately one hour. After the infusion is complete, flush with 0.9% Sodium Chloride Injection, USP. Tysabri will be infused every four weeks.
Other Name: Natalizumab

Detailed Description:

The specific aims are:

  1. To determine the effects of Tysabri on cognition (memory, thought processes, etc.)
  2. To determine the effects of Tysabri on specific MRI markers for cognitive dysfunction
  3. To determine the effects of Tysabri on retinal nerve fiber layer thickness (RNFL) using optical coherence tomography (OCT), a special instrument used in ophthalmology
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 through 60 years of age inclusive
  • Diagnosis of relapsing remitting multiple sclerosis
  • Prior to treatment phase, have had disease activity with at least 1 documented relapse during the previous year OR 2 documented relapses during the previous 2 years OR one or more new MRI lesions (Gd+ and/or T2 hyperintense)
  • An Expanded Disability Status Scale (EDSS) score of 0-4.5 inclusive
  • Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to treatment
  • Never been treated with Tysabri/natalizumab.

Exclusion Criteria:

  • Another type of MS other than relapsing remitting multiple sclerosis (RRMS)
  • A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome/immunocompromised
  • A history or presence of cancer (except for successfully treated basal or squamous cell carcinoma of skin)
  • Active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively
  • Have received any live or live attenuated vaccines (including for varicella-zoster virus or Measles) within the last 2 months
  • Have received total lymphoid irradiation or bone marrow transplantation
  • Have been treated with: corticosteroids or adrenocorticotropic hormones (ACTH) within the last month, IFN-β or glatiramer acetate within the last 3 months, immunosuppressive medications such as azathioprine or methotrexate within the last 6 months, immunoglobulins and/or monoclonal antibodies (including natalizumab) within the last 6 months, or cladribine, cyclophosphamide or mitoxantrone at any time.
  • Any medically unstable condition or a progressive neurological disorder, other than MS, which may affect participation in the study
  • History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease
  • Unable to undergo MRI scans, including claustrophobia, have a pacemaker or history of hypersensitivity to gadolinium-DTPA
  • Have had a relapse within 30 days prior AND/OR not stabilized from a previous relapse
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity to natalizumab/Tysabri
  • A clinically significant infectious disease, such as cellulitis, pneumonia, septicemia
  • History of progressive multifocal leukoencephalopathy(PML)
  • Participation in any clinical research study evaluating another investigational drug or therapy within the last 6 months
  • History of Tysabri therapy
  • Abnormal screening blood test
  • Females who are not postmenopausal for at least 1 year, surgically sterile or willing to practice effective contraception during the study
  • Nursing mothers, pregnant women, and women planning to become pregnant while on 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: NCT01071512

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Biogen
Investigators
Principal Investigator: Jacqueline Bernard, M.D. University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01071512     History of Changes
Other Study ID Numbers: 10-094A
Study First Received: February 17, 2010
Results First Received: June 15, 2017
Last Updated: August 4, 2017

Keywords provided by University of Chicago:
MRI
OCT
Tysabri
Multiple Sclerosis
cognition

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

ClinicalTrials.gov processed this record on September 21, 2017