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Summary: Investigators worldwide are recruiting 1350 people with MS to study the safety and effectiveness of glatiramer acetate (Teva Pharmaceutical Industries, Ltd.). The current approved dose for glatiramer acetate is 20 mg per day delivered subcutaneously (under the skin), and this study is investigating the effectiveness of a higher dose, 40 mg, given less frequently (three times a week). The one-year study is funded by Teva Pharmaceutical Industries, Ltd., and is also called the GALA study.
Rationale: Glatiramer acetate is a synthetic protein that simulates myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. This therapy seems to block myelin-damaging T-cells through a mechanism that is not completely understood. Glatiramer acetate is approved by the U.S. Food and Drug Administration to reduce the frequency of relapses in patients with relapsing-remitting MS and for use in individuals who have experienced a first clinical episode (clinically-isolated syndrome) and have MRI features that are consistent with MS.
Eligibility and details: Participants should be 18 to 55 years of age with a confirmed diagnosis of relapsing-remitting MS. Participants must be in a relapse-free, stable neurological condition for a minimum of 30 days, but have experienced at least one documented relapse in the past 12 months, two documented relapses in the past 24 months, or one documented relapse between 12 and 24 months with disease activity on MRI. Further details on enrollment criteria are available from the contact below.
Participants will be randomly assigned to receive either glatiramer acetate 40 mg or inactive placebo three times a week subcutaneously for 12 months. The primary endpoint being measured is the effectiveness in reducing the total number of relapses, and secondary endpoints being measured are new disease activity on MRI, cumulative disease activity on MRI, and brain tissue volume loss. Other endpoints under study include quality of life.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please email[email protected].
Sites are going to be recruiting in the following U.S. cities:
Akron, OH
Aurora, CO
Boulder, CO
Centennial, CO
Columbus, OH
Dayton, OH
Detroit, MI
Fort Collins, CO
Fullerton, CA
Gilbert, AZ
Kirkland, WA
La Jolla, CA
Lenexa, KS
Lexington, KY
Lubbock, TX
Miami, FL
Naples, FL
Nashville, TN
Northbrook, IL
Oklahoma City, OK
Phoenix, AZ
Pompano Beach, FL
Ponte Verde, FL
Richmond, VA
Roanoke, VA
Round Rock, TX
Salt Lake City, UT
San Antonio, TX
Sarasota, FL
Shreveport, LA
Tampa, FL
Uniontown, OH
Vero Beach, FL
Vienna, VA
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