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From the Department of Neurology (Drs. Johnson and Panitch), University of Maryland, Baltimore, MD; the Department of Neurology (Dr. Brooks), University of Wisconsin, Madison, WI; the Department of Neurology (Dr. Cohen), University of Pennsylvania, Philadelphia, PA; the Department of Neurology (Dr. Ford), University of New Mexico, Albuquerque, NM; the Department of Neurology (Drs. Goldstein and Vollmer), Yale University, New Haven, CT; the Department of Neurology (Dr. Lisak), Wayne State University, Detroit, MI; the Department of Neurology (Dr. Myers), University of California, Los Angeles, CA; the Department of Neurology (Dr. Rose), University of Utah/VAMC, Salt Lake City, UT; the Department of Neurology (Dr. Schiffer), University of Rochester, NY; the Department of Neurology (Dr. Weiner), University of Southern California, Los Angeles, CA; and the Department of Neurology (Dr. Wolinsky), University of Texas, Houston, TX.
Address correspondence and reprint requests to Dr. Kenneth P. Johnson, Department of Neurology, University of Maryland Hospital, 22 S. Greene Street, Baltimore, MD 21201.
When 251 relapsing-remitting patients with multiple sclerosis were randomized to receive daily subcutaneous injections of glatiramer acetate, previously called copolymer 1 (Copaxone; n = 125) or placebo (n = 126) for 24 months, there were no laboratory abnormalities associated with glatiramer acetate treatment and it was well tolerated with few side effects. Patients receiving glatiramer acetate had significantly fewer relapses and were more likely to be neurologically improved, whereas those receiving placebo were more likely to worsen. This study was extended for 1 to 11 months (mean of 5.2 months for the glatiramer acetate group and 5.9 months for the placebo group). The blinding and study conditions used during the core 24-month study were unchanged throughout the extension. The results of this extension study confirm the excellent tolerance and safety profile of glatiramer acetate for injection. The clinical benefit of glatiramer acetate for both the relapse rate and for neurologic disability was sustained at the end of the extension trial.
*See the Appendix on page 707 for a complete listing of the Copolymer 1 Multiple Sclerosis Study Group.
Supported by the Federal Food and Drug Administration Orphan Drug Program no. FD-4000559-01, the National Multiple Sclerosis Society no. RG 2202-A-6, and Teva Pharmaceutical Industries Ltd., Petah Tiqva, Israel.
Received February 18, 1997. Accepted in final form September 22, 1997.
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