Multifocal motor neuropathy (MMN) MedDRA version: 15.1 Level: PT Classification code 10065579 Term: Multifocal motor neuropathy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: KIOVIG
Product Name: KIOVIG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentrati
Sponsors
LFB BIOTECHNOLOGIES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient may be included in the study if all of the following criteria are fulfilled: 1. Male or female patient aged 18 to 80 years. 2. Written informed consent obtained prior to any study-related procedures. 3. Diagnosis of definite or probable MMN according to the EFNS/PNS Guideline 2010, First revision made by neuromuscular disease specialists with specific electrodiagnostic expertise. 4. Patients treated with a stable maintenance dose (without any change in doses > or =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: A patient may be included in the study if none of the following criteria is met: 1. Upper motor neuron, bulbar, cranial nerve or significant sensory deficit. 2. CSF protein >100 mg/dL (if available and done as part of a previous evaluation). 3. Any disease that may cause neuropathy or may interfere with outcome assessments, such as diabetes, vasculitis, or systemic lupus erythematosus. 4. BMI = 40 kg/m2. 5. Known hypersensitivity to the active substance or to any of the excipients of I10E (glycine and polysorbate 80) or Kiovig® (glycine). 6. History of Kiovig® use. 7. History of IgA deficiency, except if the absence of anti-IgA antibodies is documented. 8. Patient infected with hepatitis B virus (HBV) and/or hepatitis C virus (HCV), or human immunodeficiency virus (HIV). 9. Protein-losing enteropathy characterised by serum protein levels 2 times upper limit of normal range. 14. Patient treated with immunomodulator/immunosuppressor (e.g. cyclophosphamide, cyclosporine or interferon), except use at the same dose of: methotrexate, mycophenolate mofetil, or azathioprine for at least 6 months before the inclusion visit. 15. Treatment with an anti-CD20 antibody within the 12 previous months. 16. Administration of another investigational product within the last month prior to inclusion. 17. Exposure to blood products or derivatives other than commercial IgG, within 3 months prior to inclusion. 18. Positive results of pregnancy blood test or breast-feeding woman, or woman of childbearing potential without effective contraception for the duration of the study. 19. Any serious medical condition that would interfere with the clinical assessment of I10E or prevent the patient from complying with the protocol requirements. 20. Anticipated poor compliance of patient with study procedures during the 12 month duration of the study. 21. Drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of I10E compared to Kiovig® for maintenance treatment of patients with MMN in a randomised, double-blind, active comparator-controlled, cross-over design.;Secondary Objective: The secondary objective of this study is to assess the safety.;Primary end point(s): Difference between I10E and Kiovig® in the original MMRC 10 sum score (10 muscles on both sides see Table 20.1) described by Cats 2008;Timepoint(s) of evaluation of this end point: - Before the course - Efficacy assessments between 13 and 25 weeks for each period and depending on courses frequencies - End of study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference between I10E and Kiovig® in: • MMRC 10 new sum score (10 slightly different muscles on both sides chosen because they are expected to be more relevant and responsive to change; see Table 20.1) • Rasch built MMRC sum score (based on the 10 muscles in the MMRC sum score described by Cats 2008) • MMRC 14 sum score (14 muscles on both sides) • Grip strength with dynamometer in the most affected hand • Need for change of the IVIG dose or frequency due to a worsening of the patient’s neurological status with IMPs. • Change of Clinical Global Impression (CGI) • Discontinuation of study treatment • INCAT: upper and lower limbs;Timepoint(s) of evaluation of this end point: - Before the course - End of study visit - For INCAT: assessments between 13 and 25 weeks for each period and depending on courses frequencies - For Grip strength: 2 weeks (15-18 days) after the last course of each period | — |
Countries
France, Italy, Spain, United Kingdom
Contacts
Public ContactClinical trial information desk
LFB BIOTECHNOLOGIES
Outcome results
None listed