Phase
Condition
Amyotrophic Lateral Sclerosis (Als)
Myasthenia Gravis (Chronic Weakness)
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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, Firstrevision made by neuromuscular disease specialists with specific electrodiagnosticexpertise.
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 3months prior to enrolment.
Covered by national health care insurance system if required by local regulations.
Exclusion
Exclusion Criteria:
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, dietarydifficency, uncontrolled diabetes, hyperthyroidism, cancer, systemic lupuserythematosus or other connective diseases, infection with HIV, hepatitis B virus (HBV), or hepatitis C (HCV), Lyme disease, multiple myeloma, Waldenström'smacroglobulinemia, 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 thelast 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 serumalbumin levels <30 g/l or nephrotic syndrome characterised by proteinuria >=3.5 g/24hours, 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 uncontrolledhypertension.
History of venous thrombo-embolic disease, myocardial infarction, or cerebrovascularaccident.
Risk factor for blood hyperviscosity such as cryoglobulinemia or haematologicalmalignancy with monoclonal gammopathy.
Glomerular filtration rate <80 ml/min/1.73m2 measured according to the Modified Dietin 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 orimmunosuppressant 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).
Administration of another investigational product within the last month prior toinclusion.
Plasma exchange, blood products or derivatives administered with the last 3 monthsprior to screening.
Woman with positive results of pregnancy test or breast-feeding woman or woman ofchildbearing potential without an effective contraception. Effective contraception are injectible, patch or combined oestro-progestative orprogestative contraceptives, Cooper T or levonorgest releasing intra-uterine devices,depot intramuscular medroxyprogesterone, subcutaneous progestative contraceptiveimplants, condoms or occlusive caps (diaphragm or cervical/vault caps) withspermicide, true abstinence (when this is in line with the preferred and usuallifestyle of the patient).
Any serious medical condition that would interfere with the clinical assessment ofI10E or prevent the patient from complying with the protocol requirements.
Anticipated poor compliance of patient with study procedures during the 12 monthduration of the study.
Drug or alcohol abuse.
Study Design
Study Description
Connect with a study center
CHU de Bordeaux -Hôpital Haut-Lévêque
Bordeaux, 33604
FranceSite Not Available
CHU Créteil - Groupe Hospitalier Henri Mondor
Creteil, 94010
FranceSite Not Available
CHRU Lille - Hôpital Roger Salengro
Lille, 59037
FranceSite Not Available
CHU de Lyon - Hôpital Pierre Wertheimer
Lyon, 69677
FranceSite Not Available
CHU de Marseille - Hôpital de La Timone
Marseille, 13385
FranceSite Not Available
CHU de Nice - Hôpital l'Archet
Nice, 06202
FranceSite Not Available
CHU Paris - Hôpital Pitié Salpétrière
Paris, 75651
FranceSite Not Available
CHU de Saint Etienne - Hôpital Nord
Saint Etienne, 42055
FranceSite Not Available
Università di Genova - Ospedale San Martino
Genova, 16132
ItalySite Not Available
IRCCS Istituto Clinico Humanitas
Milan, 20089
ItalySite Not Available
Università Cattolica del Sacro Cuore
Roma, 00168
ItalySite Not Available
Azienda Ospedaliero Universitaria San Giovanni Battista
Turin, 10126
ItalySite Not Available
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
SpainSite Not Available
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, 15706
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainSite Not Available
Hospital Universitari i Politècnic La Fe
Valencia, 46026
SpainSite Not Available
Queen Elizabeth Hospital
Birmingham, B15 2WB
United KingdomSite Not Available
Royal Preston Hospital
Preston, PR2 9HT
United KingdomSite Not Available
Southampton General Hospital
Southampton, SO16 6YD
United KingdomSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.