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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 (LIME)
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.
Details
| Lead sponsor | Laboratoire français de Fractionnement et de Biotechnologies |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 23 |
| Start date | 2013-12 |
| Completion | 2016-07 |
Conditions
- Motor Neuron Disease
Interventions
- Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL)
- Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)
Primary outcomes
- Change between I10E and Kiovig® in the original MMRC 10 sum score described by Cats 2008 — at 6 months and 1 year
Countries
France, Italy, Spain, United Kingdom