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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 August 2016
Main ID:  NCT01951924
Date of registration: 20/09/2013
Prospective Registration: Yes
Primary sponsor: Laboratoire français de Fractionnement et de Biotechnologies
Public title: LIME Study (LFB IVIg MMN Efficacy Study) LIME
Scientific 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
Date of first enrolment: December 2013
Target sample size: 23
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01951924
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
France Italy Spain United Kingdom
Contacts
Name:     Jean-Marc LEGER, MD
Address: 
Telephone:
Email:
Affiliation:  Hôpital de la Pitié Salpêtrière - Paris 75013
Key inclusion & exclusion criteria

Inclusion Criteria:

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 within 15% of any brand of IVIg
(Kiovig® excluded) at 1 g/kg for 1-3 days up to 2 g/Kg for 2-5 days every 4 to 8
weeks (+/- 7 days), according to the EFNS/PNS Guideline 2010, First revision for at
least 3 months prior to enrolment.

5. Covered by national health care insurance system if required by local regulations.

Exclusion Criteria:

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 other ongoing disease that may cause neuropathy, such as toxin exposure, dietary
difficency, uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus
erythematosus or other connective diseases, infection with HIV, hepatitis B virus
(HBV), or hepatitis C (HCV), Lyme disease, multiple myeloma, Waldenström's
macroglobulinemia, amyloid, and hereditary neuropathy.

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. Patient who have been treated with Kiovig shall not have received Kiovig during the
last 6 months prior to enrolment.

7. History of IgA deficiency, except if the absence of anti-IgA antibodies is
documented.

8. Protein-losing enteropathy characterised by serum protein levels <60 g/l and serum
albumin levels <30 g/l or nephrotic syndrome characterised by proteinuria >=3.5 g/24
hours, serum protein levels <60 g/l and serum albumin levels <30 g/l.

9. History of cardiac insufficiency (New York Heart Association (NYHA) III/IV),
uncontrolled cardiac arrythmia, unstable ischemic heart disease, or uncontrolled
hypertension.

10. History of venous thrombo-embolic disease, myocardial infarction, or cerebrovascular
accident.

11. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological
malignancy with monoclonal gammopathy.

12. Glomerular filtration rate <80 ml/min/1.73m2 measured according to the Modified Diet
in Renal Disease (MDRD) calculation.

13. Serum levels of AST, ALT >2 times upper limit of normal range.

14. Treatment within 12 months prior to screeening with immunomodulator or
immunosuppressant agent (including but not limited to cyclophosphamide, cyclosporine,
interferon-a, interferon-b 1a, anti-CD20, alemtuzumab, azathioprine, etanarcept,
mycophenolate mofetil, methotrexate, haematopoietic stem cell transplantation).

15. Administration of another investigational product within the last month prior to
inclusion.

16. Plasma exchange, blood products or derivatives administered with the last 3 months
prior to screening.

17. Woman with positive results of pregnancy test or breast-feeding woman or woman of
childbearing potential without an effective contraception.

Effective contraception are injectible, patch or combined oestro-progestative or
progestative contraceptives, Cooper T or levonorgest releasing intra-uterine devices,
depot intramuscular medroxyprogesterone, subcutaneous progestative contraceptive
implants, condoms or occlusive caps (diaphragm or cervical/vault caps) with
spermicide, true abstinence (when this is in line with the preferred and usual
lifestyle of the patient).

18. Any serious medical condition that would interfere with the clinical assessment of
I10E or prevent the patient from complying with the protocol requirements.

19. Anticipated poor compliance of patient with study procedures during the 12 month
duration of the study.

20. Drug or alcohol abuse.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Motor Neuron Disease
Intervention(s)
Drug: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL)
Drug: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)
Primary Outcome(s)
Change between I10E and Kiovig® in the original MMRC 10 sum score described by Cats 2008 [Time Frame: at 6 months and 1 year]
Secondary Outcome(s)
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 : INCAT: upper and lower limbs [Time Frame: at 6 months and 1 year]
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: MMRC 10 new sum score (10 slightly different muscles on both sides) [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]
Change between I10E and Kiovig®: Grip strength [Time Frame: at 6 months and 1 year]
Secondary ID(s)
I10E-0901
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
TFS Trial Form Support
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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