Clinical Trials in Relapsing-Remitting Multiple Sclerosis /A New Proposal for Dealing with Basic Problems and Restrictions/

Mieczyslaw      Wender; Grazyna      Michalowska-Wender

Abstract

The natural course of multiple sclerosis is characterized by a high variability of pattern, relapse rate and different progression indices. They also present a dramatic impact on the interpretation of treatment trials. Reports, based on uncontrolled observations are therefore of little value. Currently it is generally accepted that a proper treatment trial should be double blinded and, although probably controversial, that it should be compared with a group of MS patients treated with placebo. Currently MS is considered as a generalized degenerative disease. The lesions are persistent, which is the reason why immunomodulatory treatment has to be started as early as possible. An alternative approach, somewhat suggestive for the use of placebo trials, seems to be a comparison of proposed new drug therapy group with a group of patients treated with a generally accepted reference drug.

Keywords: Multiple sclerosis, clinical trial, placebo, pathophysiology, reference drug, degenerative disease, T cell-mediated autoimmune, T2-weighted scans, T1-weighted, gadolinium enhanced, EDSS scale