SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01951924

Developed by Shray Alag, 2019.
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
HPO: Abnormal anterior horn cell morphology

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 12
CPLANE1 VRK1 IGHMBP2 UBA1 TFG SOD1 SETX CEP126 ASAH1 GLE1 SMN1 ATXN3