LIME Study (LFB IVIG MMN Efficacy Study)
Research type
Research Study
Full title
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
IRAS ID
130001
Contact name
Yusuf Rajabally
Contact email
Sponsor organisation
Laboratoire français du Fractionnement et des Biotechnologies (LFB) BIOTECHNOLOGIES
Eudract number
2012-001995-12
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Multifocal motor neuropathy is a progressively worsening condition where muscles gradually weaken and it limits hand, and to a lesser extent lower limb movements. Multifocal motor neuropathy is usually treated with intravenous immunoglobulin. The following intravenous immunoglobulins have been registered for the treatment of multifocal motor neuropathy: Tegeline® LFB in France since 2006 and Kiovig® Baxter in Europe since 2011.
This study is to recruit patients already treated with repeated courses of intravenous immunoglobulin whose doctor estimates that their immunoglobulin dosage, the number of days to administrate the course and their frequency suit to their case and should be pursued.
The purpose of this study is to compare the efficacy and safety of I10E, a new intravenous immunoglobulin with Kiovig®, another intravenous immunoglobulin.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
13/EM/0263
Date of REC Opinion
1 Aug 2013
REC opinion
Further Information Favourable Opinion