Clinical trials in relapsing-remitting multiple sclerosis (a new proposal for dealing with basic problems and restrictions)

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. Older 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. Such an approach would be easily acceptable to prove the effectiveness of recently discovered disease modifying drugs. We know that current standard methods of therapy with interferon beta or glatiramer acetate are able to decrease the relapse rate at least by one third, to elongate the intervals between the relapses and to decrease the progression indices. Currently MS is considered a generalized degenerative disease. The lesions are persistent, therefore 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, such as interferon beta or glatiramer acetate, including all clinical and MRI measures.