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Report for Clinical Trial NCT01951924

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT01951924 Motor Neuron Disease
MeSH: Motor Neuron Disease Amyotrophic Lateral Sclerosis
HPO: Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis

2 Interventions

Name: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL)

Type: Drug

Group A: I10E then Kiovig® Group B : Kiovig® then I10E

Name: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)

Type: Drug

Group A: I10E then Kiovig® Group B : Kiovig® then I10E


Primary Outcomes

Measure: Change between I10E and Kiovig® in the original MMRC 10 sum score described by Cats 2008

Time: at 6 months and 1 year

Secondary Outcomes

Measure: Change between I10E and Kiovig® in: MMRC 10 new sum score (10 slightly different muscles on both sides)

Time: at 6 months and 1 year

Measure: AEs observed and reported TAAEs (temporally associated AE) beginning at infusion or within 72H after infusion

Time: from 49 to 56 weeks

Measure: Change between I10E and Kiovig® in : Rasch built MMRC sum score (Cats 2008)

Time: at 6 months and 1 year

Measure: Change between I10E and Kiovig® in : INCAT: upper and lower limbs

Time: at 6 months and 1 year

Measure: Change between I10E and Kiovig®: Grip strength

Time: at 6 months and 1 year

Measure: Change between I10E and Kiovig® in: MMRC 14 sum score

Time: at 6 months and 1 year

Purpose: Treatment

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 I10E

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 ---



HPO Nodes


HPO:
Abnormal anterior horn cell morphology
Genes 18
ASAH1 TFG CPLANE1 CEP126 DCTN1 IGHMBP2 PRPH SMN1 SMN2 VRK1 SMN1 ATXN3 UBA1 SOD1 SMN1 NEFH SETX GLE1
Amyotrophic lateral sclerosis
Genes 77
MATR3 TREM2 VCP FUS PRPH ANXA11 ALS2 C9ORF72 HNRNPA1 PRPH PFN1 FUS UBQLN2 SQSTM1 ATXN2 MATR3 TBK1 CHMP2B SIGMAR1 PON1 OPTN MAPT MATR3 ANG VCP DAO ERBB4 SQSTM1 SPG11 NEFH EPHA4 CCNF ANG TARDBP DCTN1 PON2 SOD1 ANXA11 UBQLN2 GLT8D1 FIG4 OPTN DCTN1 TARDBP CHMP2B VAPB SIGMAR1 HNRNPA1 CFAP410 PFN1 PSEN1 HNRNPA1 SOD1 SPG11 C9ORF72 ALS2 TRPM7 ERBB4 CHCHD10 KIF5A VAPB PON3 FIG4 GLE1 NEK1 CHCHD10 PPARGC1A TUBA4A VCP UNC13A TBK1 VCP HNRNPA2B1 TAF15 FUS NEFH SETX