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 14. 慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー [臨床試験数:65,薬物数:91(DrugBank:23),標的遺伝子数:13,標的パスウェイ数:15] 

Searched query = "Chronic inflammatory demyelinating polyneuropathy", "Chronic inflammatory demyelinating poly (radiculo) neuropathy", "Multifocal motor neuropathy", "CIDP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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Inclusion_
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Target_
size
PhaseCountries
1NCT03772717October 201930 September 2019Non-invasive Vagus Nerve Stimulation (nVNS) in Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Non-invasive Vagus Nerve Stimulation (nVNS) in Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic Inflammatory Demyelinating PolyneuropathyDrug: Standard of Care;Device: Vital EMS+Emory UniversityGeorgia Institute of TechnologyNot recruiting5 Years21 YearsAll10N/AUnited States
2NCT04051944August 21, 201928 October 2019A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating PolyradiculoneuropathyAn Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Drug: RozanolixizumabUCB Biopharma S.P.R.L.Recruiting18 YearsN/AAll34Phase 2United States;Spain
3JPRN-UMIN0000357532019/03/2823 April 2019The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical TrialThe Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE TrialChronic Inflammatory Demyelinating PolyneuropathyCIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.

CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155):
Administer placebo IV infusion once weekly for 4 doses.
CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.
Nagoya University HospitalZenyaku Kogyo Co., Ltd.Recruiting12years-oldNot applicableMale and Female25Phase 2Japan
4JPRN-jRCT204118003728/03/201922 July 2019RECIPE TrialThe Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE TrialChronic Inflammatory Demyelinating Polyneuropathy
Chronic Inflammatory Demyelinating Polyneuropathy
CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) or placebo IV infusion once weekly for 4 doses.
CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.
Masahiro IijimaRecruiting>=12 age oldBoth25Phase 2none
5NCT03861481March 26, 201911 November 2019A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating PolyradiculoneuropathyA Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Drug: Rozanolixizumab;Other: PlaceboUCB Biopharma S.P.R.L.Recruiting18 YearsN/AAll34Phase 2United States;Belgium;France;Germany;Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03684018February 28, 20194 November 2019Single vs. Multiple Privigen Dose Regimens in Pediatric CIDPRandomized Study of Single vs. Multiple Privigen Dose Regimens in Pediatric CIDPPediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Biological: IgPro10CSL BehringRecruiting2 Years16 YearsAll30Phase 4United States;Canada
7NCT03801135October 3, 201821 January 2019Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate AnticoagulationA Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors ReplacementHumoral Rejection;Guillain-Barre Syndrome;Miller Fisher Syndrome;CIDP;Good Pasture Syndrome;Hyperviscosity SyndromeDrug: Fibrinogen concentrate;Other: Fresh Frozen PlasmaUniversity Medical Centre LjubljanaRecruiting18 YearsN/AAll20N/ASlovenia
8NCT02638207September 27, 20177 October 2019Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) NeuropathyProspective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(Radiculo)NeuropathyChronic Inflammatory Demyelinating Poly(Radiculo)NeuropathyDrug: NewGamOctapharmaNot recruiting18 YearsN/AAll142Phase 3Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Romania;Russian Federation;Ukraine;Australia;Denmark;Sweden
9EUCTR2017-002024-24-DK08/09/201716 October 2017Systematic reduction in dosage of subcutanoeus immunoglobulin in patients with chronic inflammatory neuropathyRandomized, cohort study of standardized reduction of subcutaneous immunoglobulin treatment in patients with chronic inflammatory demyelinating polyneuropathyChronic inflammatory demyelinating polyneuroapthy
MedDRA version: 20.0 Level: LLT Classification code 10077384 Term: Chronic inflammatory demyelinating polyneuropathy System Organ Class: 100000014567 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gammanorm
Product Name: Gammanorm
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 165-
Trade Name: Hizentra
Product Name: Hizentra
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Trade Name: Subcuvia
Product Name: Subcuvia
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
Aarhus Unversity HospitalAuthorisedFemale: yes
Male: yes
Phase 4Denmark
10NCT03166527June 1, 201716 December 2017Panzyga in CIDP Administered at Different Infusion RatesProspective, Open-Label, Phase IIIb Study Evaluating the Safety, Tolerability and Efficacy of Panzyga® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy Administered at Standard and High Infusion RatesChronic Inflammatory Demyelinating Polyneuropathy (CIDP)Drug: Immune Globulin 10% Intravenous SolutionVera BrilNot recruiting18 YearsN/AAll30Phase 3Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2015-005443-14-DE28/04/201728 February 2019Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy.Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 20.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: PANZYGA
Product Name: NewGam
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Immunoglobulin G
CAS Number: 308067-58-5
Other descriptive name: IMMUNOGLOBULIN G
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous drip use (Noncurrent)
Octapharma Pharmazeutika Produktionsges.m.b.H.Authorised Female: yes
Male: yes
140Phase 3Sweden;Germany;Bulgaria;Russian Federation;Australia;Denmark;Romania;Ukraine;Poland;Canada;Czech Republic;Hungary
12NCT02955355December 12, 201617 September 2018Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDPLong-Term Tolerability and Safety of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Chronic Inflammatory Demyelinating PolyradiculoneuropathyBiological: HYQVIABaxalta now part of ShireRecruiting18 YearsN/AAll149Phase 3Canada;Czechia;Denmark;France;Greece;Italy;Serbia;Slovakia;Spain;Turkey;United Kingdom
13EUCTR2016-000374-37-FR28/10/20166 February 2017Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIPDLong-Term Tolerability and Safety of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Chronic inflammatory demyelinating polyradiculoneuropathy
MedDRA version: 19.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: HyQvia 100 mg/ml solution for infusion for subcutaneous use
Product Name: HyQvia
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Baxalta Innovations GmbHAuthorisedFemale: yes
Male: yes
149Phase 3Serbia;Slovakia;Greece;Spain;Turkey;Israel;Colombia;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Denmark;Norway;Germany;Sweden
14NCT02885259September 20165 September 2016HyQvia in Multifocal Motor NeuropathySubcutaneous Immunoglobulin With rHuPH20 in Multifocal Motor NeuropathyMultifocal Motor NeuropathyDrug: rHuPH20UMC UtrechtNot recruiting18 Years99 YearsBoth20N/ANetherlands
15NCT02967679September 201628 November 2016SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot StudyChronic Inflammatory Demyelinating Polyneuropathy;Peripheral Neuropathy;Charcot-Marie-Tooth Disease;Charcot-Marie-Tooth Disease Type 1A;Charcot-Marie-Tooth Disease, Type IADrug: MD1003MedDay Pharmaceuticals SARecruiting20 Years85 YearsBoth15Phase 1/Phase 2France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
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agemax
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size
PhaseCountries
16EUCTR2015-000828-28-NL26/07/20168 August 2016Immunoglobulins given under the skin to treat patients with multifocal motor neuropathy (MMN). To increase the amount of immunoglobulins, an enzyme is added that will temporarily create more space under the skin. This space is filled with immunoglobulins. By this way less infusions should be needed.Titlle: Subcutaneous immunoglobulins with rHuPH20 in multifocal motor neuropathy (MMN) It is an interventional cross-over study where the use of the combination of subcutaneous immunoglobulins together with the enzyme hyaluronidase (rHuPH20) is compared with the current gold standard intravenous immunoglobulins (IVIg). Non-inferiority and tolerability are studied in 20 MMN patients. The reason to add rHuPH20 is to increase volumes per infusion and in this way contribute to reduced frequency of infusions. - HymneNon-inferiority and safety/tolerance of Hyqvia compared to IVIg in 20 MMN patients with at least one conduction block on EMG and stable on IVIg.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Hyqvia
Product Name: Hyqvia
Pharmaceutical Form: Concentrate for solution for injection/infusion
UMC UtrechtAuthorisedFemale: yes
Male: yes
Phase 3Netherlands
17NCT02556437June 201611 June 2018Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)Randomized, Single-blind, Cross-over Study Investigating the Non-inferiority of Efficacy and Safety of HyQvia in Comparison With Conventional Subcutaneous Ig Therapy in Multifocal Motor NeuropathyMultifocal Motor NeuropathyDrug: HyQvia;Drug: SubcuviaJohannes JakobsenBaxter Healthcare CorporationNot recruiting18 Years90 YearsAll18Phase 2Denmark
18NCT02549170April 29, 20164 November 2019Phase III Efficacy, Safety, and Tolerability Study of HYQVIA/HyQvia and GAMMAGARD LIQUID/KIOVIG in CIDPA Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Chronic Inflammatory Demyelinating PolyradiculoneuropathyBiological: HYQVIA;Biological: 0.25% albumin placebo solution with rHuPH20;Biological: IGIVBaxalta now part of ShireBaxalta Innovations GmbH, now part of ShireRecruiting18 YearsN/AAll232Phase 3United States;Argentina;Austria;Brazil;Canada;Colombia;Czechia;Denmark;France;Germany;Greece;Israel;Italy;Mexico;Norway;Poland;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic
19EUCTR2015-003453-18-DK25/11/201521 May 2018Study of the effect and safety of a new immunoglobulin preparation (HyQvia) for subcutaneous usage in patients with Multifocal Motor NeuropathyA Randomized, Single-blinded, Cross-over Study investigating the Non-inferiority of Efficacy and Safety of HyQvia in comparison with Conventional Subcutaneous Ig Therapy in Multifocal Motor NeuropathyMultifocal Motor Neuropathy (MMN)
MedDRA version: 18.1 Level: PT Classification code 10064135 Term: Polyneuropathy chronic System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: HyQvia
Product Name: HyQvia
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Trade Name: Subcuvia
Product Name: Subcuvia
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
RigshospitaletNot RecruitingFemale: yes
Male: yes
20Phase 2Denmark
20NCT02317562November 201516 December 2017Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302International, Multicentre, Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM Study I10E-1302Chronic Inflammatory Demyelinating PolyradiculoneuropathyDrug: I10ELaboratoire français de Fractionnement et de BiotechnologiesNot recruiting18 YearsN/AAll19Phase 3France;Italy;Spain;Tunisia;Turkey;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02574962August 20158 August 2016Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating NeuropathyPilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating NeuropathyChronic Inflammatory Demyelinating PolyneuropathyDrug: H.P. Acthar® GelMamatha Pasnoor, MDMallinckrodtNot recruiting18 YearsN/ABoth0Phase 2United States
22NCT02293460May 201516 December 2017Efficacy and Safety Study of I10E in Treatment of Patients With CIDPAn International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.Chronic Inflammatory Demyelinating PolyradiculoneuropathyDrug: I10ELaboratoire français de Fractionnement et de BiotechnologiesNot recruiting18 YearsN/AAll43Phase 3France;Italy;Spain;Tunisia;Turkey;United Kingdom;Morocco
23NCT02414490March 201517 June 2019IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength MeasurementsIntravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER)Chronic Inflammatory Demyelinating PolyneuropathyDrug: Intravenous ImmunoglobulinUniversity of Minnesota - Clinical and Translational Science InstituteBriovaRx Infusion Services;CSL BehringNot recruiting18 Years85 YearsAll30Phase 4United States
24NCT02372149February 201521 November 2016IVIg for Demyelination in Diabetes MellitusTreatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot StudyPeripheral Neuropathy;Diabetes Mellitus;Chronic Inflammatory Demyelinating PolyneuropathyDrug: 10% intravenous immunoglobulin (IVIg);Drug: 0.9% sodium chlorideUniversity of TorontoUniversity Health Network, TorontoRecruiting18 YearsN/ABoth25Phase 4Canada
25NCT02404298February 201518 June 2018Transcriptome Analysis of the Peripheral Blood in CIDPIdentification of the Mechanisms of Action of Intravenous Immunoglobulins in CIDP by Analysis of the Genetic Expression Profile in Blood Mononuclear CellsChronic Inflammatory Demyelinating Polyradiculoneuropathy;Autoimmune Diseases;Clarkson Syndrome;Muscular Autoimmune DisordersDrug: IVIgAssistance Publique - Hôpitaux de ParisNot recruiting18 YearsN/AAll50N/AFrance
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2013-005558-31-GB08/01/201510 July 2017Extension of the international study on efficacy and safety of I10E in CIDP patientsInternational, multicentre, efficacy and safety study of I10E in the maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM study I10E-1302 - PRISM 2Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 20.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IQYMUNE
Product Name: Human normal 10% immunoglobulin for intravenous administration
Product Code: I10
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Current Sponsor code: I10
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
LFB BIOTECHNOLOGIESAuthorisedFemale: yes
Male: yes
30Phase 3France;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
27EUCTR2012-005150-34-NL18/11/20147 December 2015Dose response study of intravenous immunoglobulin in CIDPDose response trial of IV immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathyChronic inflammatory demyelinating polyradiculoneuropathy.
MedDRA version: 18.1 Level: LLT Classification code 10035325 Term: Plasma immunoglobulin G decreased System Organ Class: 100000004848 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kiovig
Pharmaceutical Form: Solution for infusion
Erasmus MCAuthorisedFemale: yes
Male: yes
17Netherlands
28EUCTR2013-005557-73-GB21/10/201430 April 2019An international study on efficacy and safety of I10E in CIDP patientsAn international, multicentre, efficacy and safety study of I10E in initial and maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy - PRISMChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 20.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IQYMUNE
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Current Sponsor code: I10E
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
LFB BIOTECHNOLOGIESNot Recruiting Female: yes
Male: yes
42Phase 3France;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
29NCT02465359September 20146 May 2019Subcutaneous Immunoglobulin for CIDPA Study of Subcutaneous Immunoglobulin as Chronic Treatment for Patients With Chronic Inflammatory Demyelinating PolyneuropathyChronic Inflammatory Demyelinating PolyneuropathyDrug: Immune Globulin Subcutaneous (Human)University of South FloridaCSL BehringNot recruiting18 Years80 YearsAll20N/AUnited States
30NCT02027701July 30, 20148 January 2018Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Subjects Completing Study IgPro20_3003Chronic Inflammatory Demyelinating Polyneuropathy (CIDP);Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingBiological: IgPro20CSL BehringNot recruiting18 YearsN/AAll82Phase 3United States;Australia;Canada;Czechia;France;Germany;Italy;Japan;Netherlands;Spain;United Kingdom;Czech Republic;Finland
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
31EUCTR2013-004988-32-NL22/01/201416 January 2017Pharmacokinetics of IVIg treatment in patients with CIDPRotterdam Observational Study in CIDP of Pharmacokinetics of Intravenous ?-globulin - ROCKY-1Chronic Inflammatory Demyelinating Polyneuropathy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Kiovig
Product Name: Kiovig
Pharmaceutical Form: Solution for injection/infusion
Erasmus MCNot RecruitingFemale: yes
Male: yes
Phase 4Netherlands
32JPRN-JapicCTI-14247110/1/20142 April 2019Phase 3 study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP)Open-label, uncontrolled, before-and-after study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP) (Phase 3 study)Chronic inflammatory demyelinating polyneuropathy(CIDP)Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS)
Dosage And administration of the intervention : Intravenous drip infusion
Control intervention name : null
TEIJIN PHARMA LIMITED2074BOTH30Phase 3
33JPRN-JapicCTI-14247210/1/20142 April 2019Phase 3 study of GGS in multifocal motor neuropathy (MMN)Open-label, uncontrolled, before-and-after study of GGS in multifocal motor neuropathy (MMN) (Phase 3 study)Multifocal motor neuropathy (MMN)Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS)
Dosage And administration of the intervention : Intravenous drip infusion
Control intervention name : null
TEIJIN PHARMA LIMITED2074BOTH5Phase 3
34NCT02111590January 201428 September 2015Immunoglobulin Dosage and Administration Form in CIDP and MMNThe Influence of Immunoglobulin Dosage and Administration on Development of Hemolytic Anemia and Variation on Muscle Strength in Patients With CIDP and MMNChronic Inflammatory Demyelinating Polyneuropathy;Multifocal Motor Neuropathy;Hemolytic AnemiaDrug: ImmunoglobulinsRigshospitalet, DenmarkAarhus University Hospital;Octapharma Pharmazeutika Produktionsges.m.b.H.Not recruiting18 Years80 YearsBoth36N/ADenmark
35NCT01951924December 20138 August 2016LIME Study (LFB IVIg MMN Efficacy Study)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 NeuropathyMotor Neuron DiseaseDrug: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL);Drug: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)Laboratoire français de Fractionnement et de BiotechnologiesTFS Trial Form SupportNot recruiting18 Years80 YearsBoth23Phase 3France;Italy;Spain;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
36NCT02494505November 18, 201325 March 2019Interest of Mycophenolate for CIDP WeaningDoes the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)Chronic Inflammatory Demyelinating PolyradiculopathyDrug: placebo;Drug: Mycophenolate MofetilAssistance Publique - Hôpitaux de ParisNot recruiting18 YearsN/AAll40Phase 3France
37EUCTR2012-001995-12-GB01/08/201321 September 2015A 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 NeuropathyA 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 NeuropathyMultifocal motor neuropathy (MMN)
MedDRA version: 18.0 Level: PT Classification code 10065579 Term: Multifocal motor neuropathy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Current Sponsor code: I10E
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
LFB BIOTECHNOLOGIESAuthorisedFemale: yes
Male: yes
20France;Spain;United Kingdom
38EUCTR2012-001996-34-FR10/07/201326 August 2013A comparative, double-blind, randomised, multicentre efficacy and safety study of ClairYg® versus Tégéline® in maintenance treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)A comparative, double-blind, randomised, multicentre efficacy and safety study of ClairYg® versus Tégéline® in maintenance treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Chronic Inflammatory Demyelinating Polyradiculoneuropathy
MedDRA version: 15.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: CLAIRYG 50mg/ml
Product Name: CLAIRYG 50 mg/ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Trade Name: TEGELINE 50mg/ml
Product Name: TEGELINE 50mg/ml
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
LFB BIOTECHNOLOGIESAuthorisedFemale: yes
Male: yes
France
39EUCTR2013-001428-20-DK06/06/201313 June 2016Study of the effect of subcutaneous administration of immunoglobulin in patients with newly diagnosed chronic inflammatory demyelinating polyradiculoneuropathyRandomized, single-blind crossover study of subcutaneous immunoglobulin in newly diagnosed patients with chronic inflammatory demyelinating polyradiculoneuropathyChronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 16.0 Level: PT Classification code 10064135 Term: Polyneuropathy chronic System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra
Product Name: Hizentra
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Human normal immunoglobulin
CAS Number: 0
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Trade Name: Privigen
Product Name: Privigen
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Human normal immunoglobulin
CAS Number: 0
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Aarhus University HospitalNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
40NCT01824251April 201325 January 2016Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.Chronic Inflammatory Demyelinating PolyneuropathyDrug: NPB-01Nihon Pharmaceutical Co., LtdNot recruiting20 Years100 YearsBoth49Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
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agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
41NCT01827072April 201325 January 2016Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Multifocal Motor Neuropathy.Multifocal Motor NeuropathyDrug: NPB-01Nihon Pharmaceutical Co., LtdNot recruiting20 Years100 YearsBoth13Phase 3Japan
42NCT01625182December 22, 201216 December 2017Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Chronic Inflammatory Demyelinating PolyradiculoneuropathyDrug: Fingolimod;Drug: Placebo ComparatorNovartis PharmaceuticalsMitsubishi Tanabe Pharma CorporationNot recruiting18 Years75 YearsAll106Phase 3United States;Australia;Belgium;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Netherlands;Poland;Spain;United Kingdom;Czech Republic;Norway
43JPRN-JapicCTI-12196101/9/20122 April 2019A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Intervention name : FTY720
INN of the intervention : fingolimod
Dosage And administration of the intervention : oral daily, 0.5 mg
Control intervention name : placebo
Dosage And administration of the control intervention : oral daily
Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K.18BOTH156Phase 3
44EUCTR2011-003448-28-DE20/04/201217 October 2016Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATHChronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 19.0 Level: PT Classification code 10061811 Term: Demyelinating polyneuropathy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CAS Number: 0
Current Sponsor code: IgPro10-SOL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
CSL Behring GmbHNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan
45NCT01545076March 201216 July 2018Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH StudyChronic Inflammatory Demyelinating Polyneuropathy;PolyradiculoneuropathyBiological: IgPro20 (low dose);Biological: Placebo;Biological: IgPro10;Biological: IgPro20 (high dose)CSL BehringICON Clinical ResearchNot recruiting18 YearsN/AAll208Phase 3United States;Australia;Belgium;Canada;Czechia;Estonia;Finland;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Spain;United Kingdom;Austria;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
46NCT01225276October 201116 December 2017Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDPDouble-blind, Placebo-controlled, Randomised, Multicentre, Adaptive, Two-stage Phase 2/3 Study Evaluating Safety and Efficacy of Three Dosages of NewGam in CIDP PatientsChronic Inflammatory Demyelinating PolyradiculoneuropathyDrug: NewGam 10%;Drug: PlaceboOctapharmaNot recruiting18 YearsN/AAll2Phase 2/Phase 3
47EUCTR2009-017805-13-CZ14/07/201119 February 2018PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 14.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders
Product Name: NewGam
Product Code: NewGam
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Immunoglobuline G
Other descriptive name: NewGam
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 86-110
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Octapharma AGNot RecruitingFemale: yes
Male: yes
172Phase 2;Phase 3Czech Republic;Bulgaria
48EUCTR2009-017672-24-BE13/09/201021 August 2017A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP)A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 13.1 Level: PT Classification code 10061811 Term: Demyelinating polyneuropathy System Organ Class: 10029205 - Nervous system disorders
Trade Name: Privigen®
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity)
CAS Number: 0
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-
CSL Behring GmbHNot RecruitingFemale: yes
Male: yes
30Phase 3Finland;Belgium
49EUCTR2009-013841-27-DK17/12/200919 March 2012A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN TrialA Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN TrialMultifocal motor neuropathy
MedDRA version: 12.0 Level: LLT Classification code 10065579 Term: Multifocal motor neuropathy
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: IGIV, 10%
Pharmaceutical Form: Solution for infusion
CAS Number: 0
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Baxter Innovations GmbHNot RecruitingFemale: yes
Male: yes
40Denmark
50EUCTR2009-013930-25-DK24/11/200918 March 2013Randomiseret, dobbelt blindet placebokontrolleret undersøgelse af subkutan immunglobulinbehandling af kronisk inflammatorisk demyeliniserende polyradikuloneuropati (English: A randomized, double-blinded, placebo controlled trial of subcutaneous infusion of immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy) - Subcutaneous Immunoglobulin in CIDPRandomiseret, dobbelt blindet placebokontrolleret undersøgelse af subkutan immunglobulinbehandling af kronisk inflammatorisk demyeliniserende polyradikuloneuropati (English: A randomized, double-blinded, placebo controlled trial of subcutaneous infusion of immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy) - Subcutaneous Immunoglobulin in CIDPChronic inflammatory demyelinating polyradiculoneuropathy
MedDRA version: 12.0 Level: LLT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy
Trade Name: Subcuvia
Pharmaceutical Form: Concentrate for solution for injection
CAS Number: 0
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Concentrate for solution for injection
Route of administration of the placebo: Subcutaneous use
Aarhus University Hospital, Department of NeurologyNot RecruitingFemale: yes
Male: yes
Denmark
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
51NCT00962429February 200919 February 2015Lipoic Acid to Treat Chronic Inflammatory Demyelinating PolyneuropathyLipoic Acid for Chronic Inflammatory Demyelinating Polyneuropathy—A Randomized, Double-Blind, Placebo Controlled Pilot StudyCIDP;Chronic Inflammatory Demyelinating PolyneuropathyDrug: lipoic acidOregon Health and Science UniversityCollins Medical TrustNot recruiting18 Years80 YearsBoth8Phase 2United States
52EUCTR2008-005748-18-GB02/01/200919 March 2012SAFETY AND TOLERABILITY OF ECULIZUMAB IN THE TREATMENT OF MULTIFOCAL MOTOR NEUROPATHY: AN OPEN LABEL STUDYSAFETY AND TOLERABILITY OF ECULIZUMAB IN THE TREATMENT OF MULTIFOCAL MOTOR NEUROPATHY: AN OPEN LABEL STUDYMultifocal motor neuropathy
MedDRA version: 9.1 Level: PT Classification code 10065579 Term: Multifocal motor neuropathy
Trade Name: SOLIRIS
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: eculizumab
Current Sponsor code: h5G1.1-mAb
Other descriptive name: Anti-C5 antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Greater Glasgow and Clyde NHS Board and The University Of GlasgowNot RecruitingFemale: yes
Male: yes
United Kingdom
53NCT00666263August 200816 December 2017Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor NeuropathyA Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multifocal Motor NeuropathyMultifocal Motor NeuropathyBiological: Immune Globulin Intravenous (human), 10%;Biological: 0.25% human albumin solution (Placebo)Baxalta now part of ShireNot recruiting18 YearsN/AAll50Phase 3United States;Canada;Denmark;Netherlands;Poland
54NCT00716066June 20089 September 2019Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune DiseasesHigh-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic DiseasesAutoimmune Disease;Neurologic Autoimmune Disease;Autologous Transplant Autoimmune;Multiple Sclerosis Transplant;MS Stem Cell Transplant;Multiple Sclerosis Stem Cell Transplant;Stiff Person Syndrome;HCT for Neurologic Autoimmune Disorders;CIDP Transplant;Myasthenia Gravis TransplantBiological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Carmustine;Drug: Cytarabine;Drug: Etoposide;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Prednisone;Procedure: Syngeneic Bone Marrow TransplantationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)RecruitingN/A70 YearsAll40Phase 2United States
55EUCTR2007-000710-37-DE10/12/200719 March 2012A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN)A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN)Patients with multifocal motor neuropathy, who are treated successful with IVIG and had a stable IVIG treatment schedule for at least 12 weeks prior to screening.
MedDRA version: 9.1 Level: LLT Classification code 10065579 Term: Multifocal motor neuropathy
Trade Name: Vivaglobin
Product Name: Vivaglobin
Pharmaceutical Form: Solution for injection
Other descriptive name: IMMUNOGLOBULIN G
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 16-
CSL Behring AGNot RecruitingFemale: yes
Male: yes
10United Kingdom;Germany;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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gender
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size
PhaseCountries
56EUCTR2005-001136-76-IT09/07/20077 January 2013Double blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDPDouble blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDPChronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 14.1 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IGVENA*FL 200ML 10G+SET
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
Concentration unit: % percent
Concentration number: .5-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
KEDRIONNot RecruitingFemale: yes
Male: yes
Phase 3Italy
57JPRN-UMIN0000006742006/08/012 April 2019Cyclosporin A (Neoral) for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) requiring repetitive administration of high-dose intravenous immunoglobulinChronic inflammatory demyelinating polyradiculoneuropathyCyclosporin A is given orally at an initial dose of 3 mg/kg/day. The dosage of cyclosporine A is adjusted to keep a serum trough concentration between 100 and 150 ng/ml. Adiministration of high-dose intravenous immunoglobulin (0.4g/kg)is continued same as observation period.
Administration of high-dose intravenous immunoglobulin (0.4g/kg) is continued same as observation period.
CIDP Study Group18years-old70years-oldMale and Female50Not selectedJapan
58NCT00305266August 200519 February 2015Study of CIDP Patients During IVIG TreatmentClinical Study of Intravenous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating PolyradiculoneuropathyPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingDrug: intravenous gammaglobulinUniversity of AarhusNot recruiting18 Years80 YearsBoth11N/ADenmark
59NCT00278629February 21, 200511 November 2019Hematopoietic Stem Cell Transplantation in Chronic Inflammatory Demyelinating PolyneuropathyNon-myeloablative Autologous Hematopoietic Stem Cell Transplantation in Patients With Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II TrialChronic Inflammatory Demyelinating PolyneuropathyBiological: hematopoietic stem cell transplantationNorthwestern UniversityNot recruiting18 Years65 YearsAll80Phase 2United States
60NCT01349270June 200419 February 2015Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIgMulticentre Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg in Patients With Chronic Inflammatory Demyelinating Polyneuropathy on a One Year Follow upDemyelinating PolyneuropathyDrug: Immunoglobulin perfusion;Drug: PrednisoneCentre Hospitalier Universitaire de Saint EtienneLaboratoire français de Fractionnement et de BiotechnologiesNot recruiting18 Years80 YearsBoth40Phase 3France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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agemin
Inclusion_
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PhaseCountries
61NCT00220740April 200419 October 2017Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of IGIV-Chromatography (IGIV-C), 10% Treatment in Subjects With Chronic Inflammatory Demyelinating PolyneuropathyPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingDrug: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified;Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)Grifols Therapeutics Inc.Not recruiting18 YearsN/AAll117Phase 3United States;Argentina;Canada;Czech Republic;Germany;Israel;Italy;Mexico;Poland;Serbia;Former Serbia and Montenegro
62NCT00099489February 200419 February 2015Safety and Efficacy of Avonex in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of AVONEX When Used in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Chronic Inflammatory Demyelinating PolyradiculoneuropathyDrug: Interferon Beta-1aBiogen IdecNot recruiting18 Years75 YearsBoth67Phase 2United States;Australia;Canada;United Kingdom
63NCT01236456October 200319 February 2015High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating PolyneuropathyA Phase II Trial of High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating PolyneuropathyChronic Inflammatory Demyelinating PolyneuropathyDrug: CyclophosphamideStony Brook UniversityNot recruiting18 Years75 YearsBoth25Phase 2United States
64NCT00004772September 199219 February 2015Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating PolyneuropathyPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingDrug: Immune globulinNational Center for Research Resources (NCRR)Ohio State UniversityNot recruiting15 YearsN/ABoth90Phase 3
65NCT00001287December 199019 February 2015Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)The Efficacy of High-Dose Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Demyelinating Diseases;ParaproteinemiasDrug: intravenous immunoglobulin (IVIg)National Institute of Neurological Disorders and Stroke (NINDS)Not recruitingN/AN/ABoth60Phase 2United States

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