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Intravenous immunoglobulin (IVIG) treatment for patients with primary or secondary progressive multiple sclerosis - outline of a double-blind randomized, placebo-controlled trial

Neurologische Uniklinik der Ruhr-Universität Bochum am St. Josef Hospital, Gudrunstr. 56, 44791 Bochum, Germany

J. Federlein

Neurologische Uniklinik der Ruhr-Universität Bochum am St. Josef Hospital, Gudrunstr. 56, 44791 Bochum, Germany

T. Postert

Neurologische Uniklinik der Ruhr-Universität Bochum am St. Josef Hospital, Gudrunstr. 56, 44791 Bochum, Germany

M. Sailer

Institut für Neurophysiologie, Otto-von-Guericke-Universität, 39120 Magdeburg, Germany

F. Bethke

Neurologische klinik, Universität Münster, Albert-Schweitzer-St. 33, 48149 Münster, Germany

L. Kappos

Neurologische Universitätsklinik Kantonsspital Basel, Petersgraben 4, 4031 Basel, Switzerland

J. Haas

Jüdisches Krankenhaus Berlin, Iranische Strasse 2-4, 13347 Berlin, Germany

H. Przuntek

Neurologische Uniklinik der Ruhr-Universität Bochum am St. Josef Hospital, Gudrunstr. 56, 44791 Bochum, Germany

We present the design of a double-blind, randomised placebo-controlled phase III study to evaluate safety and efficacy of IVIG in the treatment of patients suffering from primary or secondary chronic progressive multiple sclerosis. The primary endpoint is disability. Two measures of disability were chosen in order to assess the primary end point: (a) sustained improvement (assessed at month 6, confirmed at month 9) and (b) progression to increasing disability of the disease (sustained for 3 months) at any time during the course of this 2 years study. The disability is measured by the Extended Disability Status Scale (EDSS). Secondary end points include the assessment of visual function, functions of the upper extremity, cognitive functions, depression and quality of life.

Key Words: chronic progressive multiple sclerosis • intravenous immunoglobulin • disability • clinical trial

Multiple Sclerosis, Vol. 3, No. 2, 149-152 (1997)
DOI: 10.1177/135245859700300217


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