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Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01071512
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : September 6, 2017
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE February 17, 2010
First Posted Date  ICMJE February 19, 2010
Results First Submitted Date June 15, 2017
Results First Posted Date September 6, 2017
Last Update Posted Date October 25, 2017
Study Start Date  ICMJE April 2010
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
specific MRI parameters and RNFL (retinal nerve fiber layer) thickness in OCT optical coherence tomography in correlation with cognition measurements [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT01071512 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
  • 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 (i.e., brain volume loss) 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis
Official Title  ICMJE Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis
Brief Summary 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).
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
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE 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
Study Arms Experimental: Tysabri
Natalizumab 300 mg IV every 4 weeks
Intervention: Drug: Tysabri
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2010)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01071512
Other Study ID Numbers  ICMJE 10-094A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Biogen
Investigators  ICMJE
Principal Investigator: Jacqueline Bernard, M.D. University of Chicago
PRS Account University of Chicago
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP