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LIME Study (LFB IVIg MMN Efficacy Study)

NCT01951924 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2016-07-19

No results posted yet for this study

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.

Conditions

  • Motor Neuron Disease

Interventions

DRUG

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

DRUG

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

Sponsors & Collaborators

  • TFS Trial Form Support

    collaborator INDUSTRY

  • Laboratoire français de Fractionnement et de Biotechnologies

    lead INDUSTRY

Principal Investigators

  • Jean-Marc LEGER, MD · Hôpital de la Pitié Salpêtrière - Paris 75013

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01951924 on ClinicalTrials.gov