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.
Name: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL)
Type: DrugGroup A: I10E then Kiovig® Group B : Kiovig® then I10E
Name: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)
Type: DrugGroup A: I10E then Kiovig® Group B : Kiovig® then I10E
Allocation: Randomized
Crossover Assignment
There is one SNP
A European, Randomised, Double-blind, Active Comparator Controlled, Cross-over, Efficacy and Safety Study of a New 10% Ready To-use Liquid Human Intravenous Immunoglobulin (I10E) Versus Kiovig® in Patients With Multifocal Motor Neuropathy. --- I10E ---
LIME Study (LFB IVIg MMN Efficacy Study) 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. --- I10E ---
Change between I10E and Kiovig® in the original MMRC 10 sum score described by Cats 2008. --- I10E ---
Change between I10E and Kiovig® in: MMRC 10 new sum score (10 slightly different muscles on both sides). --- I10E ---
Change between I10E and Kiovig® in : Rasch built MMRC sum score (Cats 2008). --- I10E ---
Change between I10E and Kiovig® in : INCAT: upper and lower limbs. --- I10E ---
Change between I10E and Kiovig®: Grip strength. --- I10E ---
Change between I10E and Kiovig® in: MMRC 14 sum score. --- I10E ---
5. Known hypersensitivity to the active substance or to any of the excipients of I10E (glycine and polysorbate 80) or Kiovig(glycine). --- I10E ---
Any serious medical condition that would interfere with the clinical assessment of I10E or prevent the patient from complying with the protocol requirements. --- I10E ---
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. --- I10E ---