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Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis

Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Tysabri (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Jacqueline Bernard, M.D., Principal Investigator, Affiliation: University of Chicago

Overall contact:
Jacqueline Bernard, M.D., Phone: 773-702-4820, Email: jbernard@neurology.bsd.uchicago.edu

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).

Clinical Details

Official title: Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: specific MRI parameters and RNFL (retinal nerve fiber layer) thickness in OCT optical coherence tomography in correlation with cognition measurements

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

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Jacqueline Bernard, M.D., Phone: 773-702-4820, Email: jbernard@neurology.bsd.uchicago.edu

University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Jacqueline Bernard, M.D., Phone: 773-702-4820, Email: jbernard@neurology.bsd.uchicago.edu
Jessica Peyton, Phone: 773-702-0159, Email: jpeyton@neurology.bsd.uchicago.edu
Jacqueline Bernard, M.D., Principal Investigator
Additional Information

Starting date: April 2010
Last updated: December 6, 2013

Page last updated: August 23, 2015

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