drugset / Trial / NCT01951924
LIME Study (LFB IVIg MMN Efficacy Study)
RandomizedCrossoverQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2013-12
- Primary completion
- 2016-07
- Completion
- 2016-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | I10E | Protein / enzyme biologic | 1 g/kg | Intravenous |
| Subject | I10E | Protein / enzyme biologic | 2 g/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 1 g/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 2 g/kg | Intravenous |