Study Enrolling to Evaluate Effects of Tysabri on Fatigue and Cognition

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http://www.nationalmssociety.org/site/PageServer?pagename=HOM_RES_research_2007dec7_2MS TRIAL ALERT:Study Enrolling to Evaluate Effects of Tysabri on Fatigue and Cognition

December 7, 2007Summary:

Researchers nationwide are enrolling people who have relapsing forms of

MS in a study to evaluate the effects of Tysabri® (natalizumab, Biogen

Idec and Elan Pharmaceuticals) on fatigue and cognition. Forty-eight

sites will recruit a total of 200 patients for this study, which is

funded by Biogen Idec.

For the purposes of this study, “relapsing forms of MS” would

include individuals who experience repeated, acute attacks or relapses

of symptoms, followed by periods of full or partial recovery.

Rationale: Tysabri is a laboratory-produced

monoclonal antibody that has been approved for marketing by the U.S.

FDA for relapsing forms of MS, based on data from two clinical trials.

Tysabri is designed to hamper the movement of potentially damaging

immune cells from the bloodstream, across the “blood-brain barrier,”

and into the brain and spinal cord. The drug inhibits this movement by

attaching to alpha 4-integrin, a protein on the surface of immune

T-cells that normally enables them to adhere to and pass through the

blood-brain barrier.

In a recently published study involving data available from 2,113

people enrolled in clinical trials of natalizumab, the drug was shown

to significantly improve quality of life as measured by several

clinical scales (Ann Neurol. 2007 Oct;62[4]:335-46). In

addition, the sponsor has unpublished data from those trials, along

with anecdotal reports, suggesting that Tysabri may have positive

impacts against fatigue. This new study is investigating the extent to

which Tysabri may affect fatigue and cognitive problems in people with

MS.

Eligibility and Details: To enroll in this study,

people must be between 18 and 55 years of age, have a diagnosis of a

relapsing form of MS, and have had an inadequate response to, or be

unable to tolerate, alternate therapies.

Patients must be enrolled in the TOUCH™ prescribing program in the U.S.,

which is designed to track opportunistic infections and to understand

their risk factors. This program was set up due to of PML (progressive

multifocal leukoencephalo­pathy), a brain disease that occurred in

three people (two of whom died) who had been in earlier clinical trials

of Tysabri. As of September 2007, 10,500 have been enrolled in this

program with no new PML cases having been confirmed.

All participants will receive Tysabri intravenously every four weeks

for 12 months. The primary objective of this study is to determine the

effects of Tysabri treatment on fatigue as measured by changes in the

Visual Analog Scale for Fatigue, and secondary objectives are to

measure changes in the Modified Fatigue Impact Scale and Fatigue

Severity Scale. These are questionnaires in which patients report the

effects of fatigue in terms of physical, cognitive, and psychosocial

functioning. Patients also will undergo neuropsychological assessments

to explore the effects of Tysabri on cognition.

Contact: For enrollment information, please contact

MS Active Source at , and ask for Medical Information.

Although not all sites are enrolling yet, participating sites will be

in the following cities:

Birmingham, AL

Huntsville, AL

Phoenix, AZ

Fresno, CA

Los Angeles, CA

Melbourne, FL

Atlanta, GA

Des Moines, IA

Idaho Falls, ID

ton, IL

Indianapolis, IN

Lexington, KY

Louisville, KY

Brighton, MA

Brookline, MA

Lexington, MA

Ann Arbor, MI

Detroit, MI

Ashville, NC

Chapel Hill, NC

High Point, NC

Freehold, NJ

Voorhees, NJ

Plainview, NY

Stony Brook, NY

Las Vegas, NV

Canton, OH

Columbus, OH

Bethlehem, PA

Collegeville, PA

Philadelphia, PA

, SC

Nashville, TN

Dallas, TX

Round Rock, TX

San , TX

Park City, UT

Richmond, VA

Vienna, VA

Seattle, WA

Madison, WI

ton, WV

-- Research and Clinical Programs Department

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Tysabri is a registered trademark of Biogen Idec and ElanTOUCH is a trademark of Biogen Idec and Elan This email is a natural hand made product. The slight variations in spelling and grammar enhance its individual character and beauty and in no way are to be considered flaws or defects.

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