ESIMS--an ongoing clinical trial in secondary progressive multiple sclerosis

Abstract

The design of a double-blind, placebo-controlled, European-Canadian Study on IVIG treatment in multiple sclerosis-ESIMS- is described. Three hundred and eighteen multiple sclerosis patients with a secondary progressive course, are treated with monthly infusions of immunoglobulin 10% 1 g/kg bodyweight or with 0.1 g albumin/vial for 27 months. The primary efficacy parameter is the percentage of patients with a confirmed treatment failure in the EDSS scale and/or the Nine Hole Peg Test Secondary outcome measures are MRI T2 lesion load, Magnetization Transfer Imaging, and MRI brainatrophy measures. Documentation of health resource utilisation and ability to work will cover socio-economic aspects. Recruitment of patients was completed in October 1998. The clinical part of the trial will be completed in April 2001.