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October 1983

A Working Protocol to Be Used as a Guideline for Trials in Multiple Sclerosis

Author Affiliations

From the Multiple Sclerosis Clinical and Research Unit, Division of Neurology, Department of Medicine, Brigham & Women's Hospital, Boston (Dr Weiner); and the Department of Neurology, UCLA (Dr Ellison).

Arch Neurol. 1983;40(11):704-710. doi:10.1001/archneur.1983.04050100044018

At the International Conference on A Therapeutic Trials in Multiple Sclerosis, it was decided that standardized working protocols should be designed for use by investigators planning clinical trials in multiple sclerosis (MS). Because a detailed protocol must take into account the local resources of the investigator, the unique properties of the therapeutic agent being tested, and the stage of the illness being treated, it is not possible to create one protocol that can be used "as is" for all clinical trials. Nonetheless, there are a large number of issues that must be addressed in all clinical trials of therapeutic agents in MS. This article addresses those issues in a form that can be used by investigators to construct specific protocols.

Depending on the stage of disease, four specific treatment goals might be addressed in a clinical trial of a therapeutic modality in MS. Because many aspects of an MS