Placebo controlled pilot trial to study the remyelinating potential of intravenous immunoglobulins in multiple sclerosis

Currently there is no treatment available to improve a stable deficit in mu ltiple sclerosis. It was shown in animal models that intravenous immunoglob ulins (IVIg) can enhance central nervous remyelination, and the first open trials were promising. We therefore conducted a double blind, placebo contr olled pilot study to evaluate the effect of IVIg treatment in patients with multiple sclerosis with a stable clinical deficit. The primary outcome par ameter was the change in central motor conduction time as an indirect measu re of central myelination. Secondary outcome parameters were neurological e xaminations including the expanded disability status scale (EDSS), neurolog ical rating scale (NRS), and manual muscle testing (MMT). Ten patients were treated first with placebo and then with IVIg (0.4 g/kg body weight on 5 c onsecutive days), the two treatments being separated by an interval of 6 we eks. There was no difference in the central motor conduction times measured before and 6 weeks after each treatment. Clinically there was a small impr ovement after IVIg treatment, but there was no significant difference when compared with placebo. In conclusion, our data do not support a role for IV Ig in the remyelination of stable multiple sclerosis lesions as measured by central conduction time. The importance of the small clinical benefit is c urrently not clear.