LIME Study (LFB IVIg MMN Efficacy Study)

NCT01951924 | Completed Phase 3

• 1 other identifier: I10E-0901
• Study Type: interventional
• Target: 23
• Locations: 4 countries
• Sites: 18

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.

Conditions

Motor Neuron Disease

Keywords

Multifocal Motor Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change between I10E and Kiovig® in the original MMRC 10 sum score described by Cats 2008

  at 6 months and 1 year

Secondary Outcomes (6)

• Change between I10E and Kiovig® in: MMRC 10 new sum score (10 slightly different muscles on both sides)

  at 6 months and 1 year

• AEs observed and reported TAAEs (temporally associated AE) beginning at infusion or within 72H after infusion

  from 49 to 56 weeks

• Change between I10E and Kiovig® in : Rasch built MMRC sum score (Cats 2008)

  at 6 months and 1 year

• Change between I10E and Kiovig® in : INCAT: upper and lower limbs

  at 6 months and 1 year

• Change between I10E and Kiovig®: Grip strength

  at 6 months and 1 year

Study Arms (2)

Group A: I10E then Kiovig®

EXPERIMENTAL

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)

Group B : Kiovig® then I10E

EXPERIMENTAL

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)

Interventions

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

Group A: I10E then Kiovig®; Group B : Kiovig® then I10E

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

Group A: I10E then Kiovig®; Group B : Kiovig® then I10E

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient aged 18 to 80 years.
• Written informed consent obtained prior to any study-related procedures.
• Diagnosis of definite or probable MMN according to the EFNS/PNS Guideline 2010, First revision made by neuromuscular disease specialists with specific electrodiagnostic expertise.
• 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.
• Covered by national health care insurance system if required by local regulations.

You may not qualify if:

• Upper motor neuron, bulbar, cranial nerve or significant sensory deficit.
• CSF protein \>100 mg/dL (if available and done as part of a previous evaluation).
• 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.
• BMI \>= 40 kg/m2.
• Known hypersensitivity to the active substance or to any of the excipients of I10E (glycine and polysorbate 80) or Kiovig(glycine).
• Patient who have been treated with Kiovig shall not have received Kiovig during the last 6 months prior to enrolment.
• History of IgA deficiency, except if the absence of anti-IgA antibodies is documented.
• 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.
• History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrythmia, unstable ischemic heart disease, or uncontrolled hypertension.
• History of venous thrombo-embolic disease, myocardial infarction, or cerebrovascular accident.
• Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
• Glomerular filtration rate \<80 ml/min/1.73m2 measured according to the Modified Diet in Renal Disease (MDRD) calculation.
• Serum levels of AST, ALT \>2 times upper limit of normal range.
• 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).
• Plasma exchange, blood products or derivatives administered with the last 3 months prior to screening.

Sponsors & Collaborators

• Laboratoire français de Fractionnement et de Biotechnologies: lead
• TFS Trial Form Support: collaborator

Study Sites (18)

CHU de Bordeaux -Hôpital Haut-Lévêque

Bordeaux, 33604, France

Location

CHU Créteil - Groupe Hospitalier Henri Mondor

Créteil, 94010, France

Location

CHRU Lille - Hôpital Roger Salengro

Lille, 59037, France

Location

CHU de Lyon - Hôpital Pierre Wertheimer

Lyon, 69677, France

Location

CHU de Marseille - Hôpital de La Timone

Marseille, 13385, France

Location

CHU de Nice - Hôpital l'Archet

Nice, 06202, France

Location

CHU Paris - Hôpital Pitié Salpétrière

Paris, 75651, France

Location

CHU de Saint Etienne - Hôpital Nord

Saint-Etienne, 42055, France

Location

Università di Genova - Ospedale San Martino

Genova, 16132, Italy

Location

IRCCS Istituto Clinico Humanitas

Milan, 20089, Italy

Location

Università Cattolica del Sacro Cuore

Roma, 00168, Italy

Location

Azienda Ospedaliero Universitaria San Giovanni Battista

Turin, 10126, Italy

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

Queen Elizabeth Hospital

Birmingham, B15 2WB, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Motor Neuron Disease

Interventions

gamma-Globulins; Administration, Intravenous

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jean-Marc LEGER, MD

  Hôpital de la Pitié Salpêtrière - Paris 75013

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: September 27, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 19, 2016

Record last verified: 2016-07

Locations

IT (4); FR (8); GB (2); ES (4)