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LIME Study (LFB IVIg MMN Efficacy Study) (LIME)

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ClinicalTrials.gov Identifier: NCT01951924
Recruitment Status : Completed
First Posted : September 27, 2013
Last Update Posted : July 19, 2016
Sponsor:
Collaborator:
TFS Trial Form Support
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies

Study Description
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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.

Condition or disease Intervention/treatment Phase
Motor Neuron Disease Drug: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL) Drug: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL) Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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® in Patients With Multifocal Motor Neuropathy
Study Start Date : December 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A: I10E then Kiovig®
1 g/kg for 1-3 days up to 2 g/kg for 2-5 days every 4 to 8 weeks (±7 days)
 Drug: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL)
Drug: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)
Experimental: Group B : Kiovig® then I10E
1 g/kg for 1-3 days up to 2 g/kg for 2-5 days every 4 to 8 weeks (±7 days)
 Drug: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL)
Drug: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. AEs observed and reported TAAEs (temporally associated AE) beginning at infusion or within 72H after infusion [ Time Frame: from 49 to 56 weeks ]
  3. Change between I10E and Kiovig® in : Rasch built MMRC sum score (Cats 2008) [ Time Frame: at 6 months and 1 year ]
  4. Change between I10E and Kiovig® in : INCAT: upper and lower limbs [ Time Frame: at 6 months and 1 year ]
  5. Change between I10E and Kiovig®: Grip strength [ Time Frame: at 6 months and 1 year ]
  6. Change between I10E and Kiovig® in: MMRC 14 sum score [ Time Frame: at 6 months and 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951924


Locations
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Sponsors and Collaborators
Laboratoire français de Fractionnement et de Biotechnologies
TFS Trial Form Support
Investigators
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Principal Investigator: Jean-Marc LEGER, MD Hôpital de la Pitié Salpêtrière - Paris 75013
More Information
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Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier: NCT01951924    
Other Study ID Numbers: I10E-0901
First Posted: September 27, 2013    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Keywords provided by Laboratoire français de Fractionnement et de Biotechnologies:
Multifocal Motor Neuropathy
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
 Proteostasis Deficiencies
Metabolic Diseases
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs