Clinical Trial: LIME Study (LFB IVIg MMN Efficacy Study)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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® i

Brief 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.

Detailed Summary:

Multifocal motor neuropathy (MMN) is a chronic acquired, probably autoimmune, demyelinating, motor neuropathy. It is a rare disease, variable in its clinical features. The disease course is usually steadily progressive.

Intravenous immunoglobulin (IVIg) is the standard and the first line treatment for MMN. The Cochrane review of four randomized placebo-controlled studies showed a significant clinical improvement in muscle strength from IVIg in 78% of patients with MMN versus 4% with placebo but a non-significant improvement in disability (39% versus 11%) (van Schaik IN, 2005). However, IVIg treatment does not prevent a mild gradual decline in muscle strength which is probably due to ongoing axonal degeneration. In addition to its efficacy, IVIg is also a safe treatment with a positive benefit-risk ratio in MMN.

Muscle strength measured with the Modified Medical Research Council (MMRC 10) sum score as described in the study of Cats (Cats EA, 2008) including 20 movements i.e. 10 muscle groups of the upper and lower limbs on each side was selected as the primary endpoint. 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.


Sponsor: Laboratoire français de Fractionnement et de Biotechnologies

Current Primary Outcome: Change between I10E and Kiovig® in the original MMRC 10 sum score described by Cats 2008 [ Time Frame: at 6 months and 1 year ]

Original Primary Outcome: Change between I10E and Kiovig® in the original MMRC 10 sum score described by Cats 2008 [ Time Frame: between 3 and 6 months and between 9 and 12 months ]

Current Secondary Outcome:

  • Change between I10E and Kiovig® in: MMRC 10 new sum score (10 slightly different muscles on both sides) [ Time Frame: at 6 months and 1 year ]
  • AEs observed and reported TAAEs (temporally associated AE) beginning at infusion or within 72H after infusion [ Time Frame: from 49 to 56 weeks ]
  • Change between I10E and Kiovig® in : Rasch built MMRC sum score (Cats 2008) [ Time Frame: at 6 months and 1 year ]
  • Change between I10E and Kiovig® in : INCAT: upper and lower limbs [ Time Frame: at 6 months and 1 year ]
  • Change between I10E and Kiovig®: Grip strength [ Time Frame: at 6 months and 1 year ]
  • Change between I10E and Kiovig® in: MMRC 14 sum score [ Time Frame: at 6 months and 1 year ]


Original Secondary Outcome:

  • Change between I10E and Kiovig® in: MMRC 10 new sum score (10 slightly different muscles on both sides) [ Time Frame: at 6 months and 1 year ]
  • AEs observed and reported TAAEs (temporally associated AE) beginning at infusion or within 72H after infusion [ Time Frame: from 49 to 56 weeks ]
  • Change between I10E and Kiovig® in : Rash built MMRC sum score (CATs 2008) [ Time Frame: at 6 months and 1 year ]
  • Change between I10E and Kiovig® in : INCAT: upper and lower limbs [ Time Frame: at 6 months and 1 year ]
  • Change between I10E and Kiovig®: Grip strengh [ Time Frame: at 6 months and 1 year ]
  • Change between I10E and Kiovig® in: MMRC 14 sum score [ Time Frame: at 6 months and 1 year ]


Information By: Laboratoire français de Fractionnement et de Biotechnologies

Dates:
Date Received: September 20, 2013
Date Started: December 2013
Date Completion:
Last Updated: July 18, 2016
Last Verified: July 2016