Short report
Placebo controlled pilot trial to study the remyelinating
potential of intravenous immunoglobulins in multiple sclerosis
Martin Stangela, Friedrich Boegnera, Christel H Klattb, Christoph Hofmeistera, Sepp Seyferta
a Department of
Neurology, Universitätsklinikum Benjamin Franklin, Freie
Universität Berlin, Hindenburgdamm 30, D-12200 Berlin, Germany, b Clinical Neurophysiology
Correspondence to: Dr M Stangel, Department of Neurology, Universitätsklinikum Benjamin Franklin, Hindenburgdamm 30, D-12200 Berlin, Germany email mstangel{at}zedat.fu-berlin.de
Received 1 June 1999 and in revised form 16 August 1999;
Accepted 3 September
1999
Currently there is no treatment available to improve a stable
deficit in multiple sclerosis. It was shown in animal models that
intravenous immunoglobulins (IVIg) can enhance central nervous remyelination, and the first open trials were promising. We therefore conducted a double blind, placebo controlled pilot study to evaluate the effect of IVIg treatment in patients with multiple sclerosis with a
stable clinical deficit. The primary outcome parameter was the change
in central motor conduction time as an indirect measure of central
myelination. Secondary outcome parameters were neurological
examinations including the expanded disability status scale (EDSS),
neurological 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 consecutive days), the two treatments being separated
by an interval of 6 weeks. There was no difference in the central motor
conduction times measured before and 6 weeks after each treatment.
Clinically there was a small improvement after IVIg treatment, but
there was no significant difference when compared with placebo. In
conclusion, our data do not support a role for IVIg in the
remyelination of stable multiple sclerosis lesions as measured by
central conduction time. The importance of the small clinical benefit
is currently not clear.
Keywords: multiple sclerosis; intravenous immunoglobulins; remyelination
© 2000 by Journal of Neurology, Neurosurgery, and Psychiatry
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