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MS Trial Alert: Investigators Recruiting for Trial of Ozanimod to Describe Cognitive Function in People with Relapsing MS

July 8, 2021

SUMMARY: Investigators are recruiting 250 people with relapsing forms of MS for a clinical trial to determine if ozanimod (Zeposia®, Bristol Myers Squibb) improves cognitive functions, specifically information processing speed. The study is funded by Celgene.

DETAILS
Rationale: The U.S. Food and Drug Administration approved Zeposia in March 2020 as an oral disease-modifying therapy for adults with relapsing forms of MS. Zeposia is thought to act by retaining certain white blood cells in the body’s lymph nodes, keeping them out of circulation and from entering the central nervous system. An analysis conducted after one clinical trial suggested that Zeposia may improve cognitive function, but the study was not specifically designed to show this benefit.  

Eligibility and Details: Participants should be 18 to 65 years old, and diagnosed (in the past five years) with a relapsing form of MS, which includes relapsing-remitting, and have not been treated with more than one disease-modifying therapy approved to treat relapsing-remitting MS at time of study entry.  Other criteria may apply.
 
This is an “open-label” study, meaning that all participants will take ozanimod by mouth daily for 36 months. The primary outcome being measured is the change in processing speed, as measured by a cognitive function scale called the “Symbol Digit Modalities Test.” Other outcomes being measured include disease activity on MRI scans, relapse rates, changes in the EDSS disability scale, impacts on fatigue, treatment satisfaction, quality of life, and safety and tolerability.

What Else is Involved? The study involves in-clinic visits every 3 months, with a total of 17 visits over 3 years. Visits will involve annual MRI scans, annual blood draws, clinical exams, and responding to questionnaires.

Please note: This study requires in-person visits to the study site. Precautions are being taken to reduce the on-site risks of exposure to COVID-19.  In the U.S., sites will be enrolling in the following cities:
Birmingham, Alabama
Cullman, Alabama
Mobile, Alabama
Phoenix, Arizona
Arcadia, California
Laguna Hills, California
Sacramento, California
Aurora, Colorado
Colorado Springs, Colorado
Fort Collins, Colorado
Washington, District of Columbia
Boca Raton, Florida
Vero Beach, Florida
Savannah, Georgia
Hoffman Estates, Illinois
Northbrook, Illinois
Fort Wayne, Indiana
Ames, Iowa
Kansas City, Kansas
Alexandria, Louisiana
Detroit, Michigan
Golden Valley, Minnesota
Saint Louis, Missouri
Great Falls, Montana
Audubon, New Jersey
Teaneck, New Jersey
Amherst, New York
Buffalo, New York
 
East Setauket, New York
New York, New York
Patchogue, New York
Chapel Hill, North Carolina
Greensboro, North Carolina
Mooresville, North Carolina
Raleigh, North Carolina
Cincinnati, Ohio
Cleveland, Ohio
Dayton, Ohio
Oklahoma City, Oklahoma
Philadelphia, Pennsylvania
Pittsburgh, Pennsylvania
Franklin, Tennessee
Knoxville, Tennessee
Dallas, Texas
Round Rock, Texas
San Antonio, Texas
Norfolk, Virginia
Kirkland, Washington
Seattle, Washington
Spokane Valley, Washington
Tacoma, Washington
Huntington, West Virginia
Morgantown, West Virginia
Madison, Wisconsin
Milwaukee, Wisconsin
 
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
 
Without participants in research studies, MS research would come to a standstill. Read more here.

Zeposia is a registered trademark of Bristol Myers Squibb.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.

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