The aim of this study is to evaluate the efficacy and safety of I10E (LFB 10% ready-to-use liquid human intravenous immunoglobulin) compared to Kiovig® for the maintenance treatment of MMN in a randomized, double-blind, active comparator-controlled, cross-over trial.
Multifocal motor neuropathy (MMN) is a chronic acquired, probably autoimmune, demyelinating, motor neuropathy. It is a rare disease, variable in its clinical features. The disease course is usually steadily progressive. Intravenous immunoglobulin (IVIg) is the standard and the first line treatment for MMN. The Cochrane review of four randomized placebo-controlled studies showed a significant clinical improvement in muscle strength from IVIg in 78% of patients with MMN versus 4% with placebo but a non-significant improvement in disability (39% versus 11%) (van Schaik IN, 2005). However, IVIg treatment does not prevent a mild gradual decline in muscle strength which is probably due to ongoing axonal degeneration. In addition to its efficacy, IVIg is also a safe treatment with a positive benefit-risk ratio in MMN. Muscle strength measured with the Modified Medical Research Council (MMRC 10) sum score as described in the study of Cats (Cats EA, 2008) including 20 movements i.e. 10 muscle groups of the upper and lower limbs on each side was selected as the primary endpoint. Other parameters of muscle strength such as measurement of grip strength by dynamometer - and functional disability will also be evaluated to reinforce the robustness of the study and substantiate the efficacy of I10E in MMN patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
CHU de Bordeaux -Hôpital Haut-Lévêque
Bordeaux, France
CHU Créteil - Groupe Hospitalier Henri Mondor
Créteil, France
Change between I10E and Kiovig® in the original MMRC 10 sum score described by Cats 2008
Time frame: at 6 months and 1 year
Change between I10E and Kiovig® in: MMRC 10 new sum score (10 slightly different muscles on both sides)
Time frame: at 6 months and 1 year
AEs observed and reported TAAEs (temporally associated AE) beginning at infusion or within 72H after infusion
Time frame: from 49 to 56 weeks
Change between I10E and Kiovig® in : Rasch built MMRC sum score (Cats 2008)
Time frame: at 6 months and 1 year
Change between I10E and Kiovig® in : INCAT: upper and lower limbs
Time frame: at 6 months and 1 year
Change between I10E and Kiovig®: Grip strength
Time frame: at 6 months and 1 year
Change between I10E and Kiovig® in: MMRC 14 sum score
Time frame: at 6 months and 1 year
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Università di Genova - Ospedale San Martino
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