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NEUROLOGY 1998;51:239-245
© 1998 American Academy of Neurology

A phase II study of IV methylprednisolone in secondary-progressive multiple sclerosis

D. E. Goodkin, MD, R. P. Kinkel, MD, B. Weinstock-Guttman, MD, S. VanderBrug Medendorp, MPH, M. Secic, MS, D. Gogol, RN, J. E. Perryman, M. M. Uccelli, BA and L. Neilley, NP

From the Mellen Center for Multiple Sclerosis Treatment and Research (Drs. Kinkel and Weinstock-Guttman, and S. VanderBrug Medendorp, M. Secic, D. Gogol, J.E. Perryman, and M.M. Uccelli), Cleveland, OH; and the USF/Mt. Zion Multiple Sclerosis Center (Dr. Goodkin and L. Neilley), San Francisco, CA.

Address correspondence and reprint requests to Dr Goodkin, the UCSF/Mt. Zion Multiple Sclerosis Center, 1600 Divisadero St., San Francisco, CA 94115.

Objective: To compare the tolerability and efficacy of two doses of IV methylprednisolone in patients with secondary-progressive MS.

Methods: IV methylprednisolone administered in high or low dose every other month for up to 2 years to 108 patients with secondary-progressive MS.

Results: No significant difference in efficacy with the primary outcome, a comparison of the proportions of patients in each treatment group who experienced sustained progression of disability. A relative treatment effect was detected with the high-dose regimen as measured by the preplanned secondary analysis, a comparison of time to onset of sustained progression of disability. Drug-related adverse events were observed more frequently in high-dose recipients but serious drug-related adverse events were uncommon, and cessation of study drug was only required in one patient.

Conclusion: The results of the secondary analysis of this study suggest that a phase III trial of corticosteroids for secondary-progressive MS is warranted.

Supported by the National Multiple Sclerosis Society (RG2350-A-3, Dr. Goodkin). Methylprednisolone and placebo tablets were supplied by The Upjohn Company, Kalamazoo, MI.

Received October 7, 1997. Accepted in final form March 28, 1998.




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