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：15，標的パスウェイ数：57］
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 of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03772717 | October 2019 | 30 September 2019 | Non-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 Polyneuropathy | Drug: Standard of Care;Device: Vital EMS+ | Emory University | Georgia Institute of Technology | Not recruiting | 5 Years | 21 Years | All | 10 | N/A | United States |
| 2 | NCT04051944 | August 21, 2019 | 28 October 2019 | A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy | An 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: Rozanolixizumab | UCB Biopharma S.P.R.L. | Recruiting | 18 Years | N/A | All | 34 | Phase 2 | United States;Spain | |
| 3 | JPRN-UMIN000035753 | 2019/03/28 | 23 April 2019 | The 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 | The 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 Trial | Chronic Inflammatory Demyelinating Polyneuropathy | CIDP 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 Hospital | Zenyaku Kogyo Co., Ltd. | Recruiting | 12years-old | Not applicable | Male and Female | 25 | Phase 2 | Japan |
| 4 | JPRN-jRCT2041180037 | 28/03/2019 | 22 July 2019 | RECIPE Trial | The 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 Trial | Chronic 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 Iijima | Recruiting | >=12 age old | Both | 25 | Phase 2 | none | ||
| 5 | NCT03861481 | March 26, 2019 | 11 November 2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A 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: Placebo | UCB Biopharma S.P.R.L. | Recruiting | 18 Years | N/A | All | 34 | Phase 2 | United States;Belgium;France;Germany;Spain | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03684018 | February 28, 2019 | 4 November 2019 | Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP | Randomized Study of Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP | Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Biological: IgPro10 | CSL Behring | Recruiting | 2 Years | 16 Years | All | 30 | Phase 4 | United States;Canada | |
| 7 | NCT03801135 | October 3, 2018 | 21 January 2019 | Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation | A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement | Humoral Rejection;Guillain-Barre Syndrome;Miller Fisher Syndrome;CIDP;Good Pasture Syndrome;Hyperviscosity Syndrome | Drug: Fibrinogen concentrate;Other: Fresh Frozen Plasma | University Medical Centre Ljubljana | Recruiting | 18 Years | N/A | All | 20 | N/A | Slovenia | |
| 8 | NCT02638207 | September 27, 2017 | 7 October 2019 | Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) 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 | Drug: NewGam | Octapharma | Not recruiting | 18 Years | N/A | All | 142 | Phase 3 | Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Romania;Russian Federation;Ukraine;Australia;Denmark;Sweden | |
| 9 | EUCTR2017-002024-24-DK | 08/09/2017 | 16 October 2017 | Systematic reduction in dosage of subcutanoeus immunoglobulin in patients with chronic inflammatory neuropathy | Randomized, cohort study of standardized reduction of subcutaneous immunoglobulin treatment in patients with chronic inflammatory demyelinating polyneuropathy | Chronic 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 Hospital | Authorised | Female: yes Male: yes | Phase 4 | Denmark | ||||
| 10 | NCT03166527 | June 1, 2017 | 16 December 2017 | Panzyga in CIDP Administered at Different Infusion Rates | Prospective, 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 Rates | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Drug: Immune Globulin 10% Intravenous Solution | Vera Bril | Not recruiting | 18 Years | N/A | All | 30 | Phase 3 | Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2015-005443-14-DE | 28/04/2017 | 28 February 2019 | Prospective, 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 | 140 | Phase 3 | Sweden;Germany;Bulgaria;Russian Federation;Australia;Denmark;Romania;Ukraine;Poland;Canada;Czech Republic;Hungary | |||
| 12 | NCT02955355 | December 12, 2016 | 17 September 2018 | Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP | Long-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 | Biological: HYQVIA | Baxalta now part of Shire | Recruiting | 18 Years | N/A | All | 149 | Phase 3 | Canada;Czechia;Denmark;France;Greece;Italy;Serbia;Slovakia;Spain;Turkey;United Kingdom | |
| 13 | EUCTR2016-000374-37-FR | 28/10/2016 | 6 February 2017 | Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIPD | Long-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 GmbH | Authorised | Female: yes Male: yes | 149 | Phase 3 | Serbia;Slovakia;Greece;Spain;Turkey;Israel;Colombia;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Denmark;Norway;Germany;Sweden | |||
| 14 | NCT02885259 | September 2016 | 5 September 2016 | HyQvia in Multifocal Motor Neuropathy | Subcutaneous Immunoglobulin With rHuPH20 in Multifocal Motor Neuropathy | Multifocal Motor Neuropathy | Drug: rHuPH20 | UMC Utrecht | Not recruiting | 18 Years | 99 Years | Both | 20 | N/A | Netherlands | |
| 15 | NCT02967679 | September 2016 | 28 November 2016 | SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study | Chronic Inflammatory Demyelinating Polyneuropathy;Peripheral Neuropathy;Charcot-Marie-Tooth Disease;Charcot-Marie-Tooth Disease Type 1A;Charcot-Marie-Tooth Disease, Type IA | Drug: MD1003 | MedDay Pharmaceuticals SA | Recruiting | 20 Years | 85 Years | Both | 15 | Phase 1/Phase 2 | France | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2015-000828-28-NL | 26/07/2016 | 8 August 2016 | Immunoglobulins 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. - Hymne | Non-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 Utrecht | Authorised | Female: yes Male: yes | Phase 3 | Netherlands | ||||
| 17 | NCT02556437 | June 2016 | 11 June 2018 | Efficacy 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 Neuropathy | Multifocal Motor Neuropathy | Drug: HyQvia;Drug: Subcuvia | Johannes Jakobsen | Baxter Healthcare Corporation | Not recruiting | 18 Years | 90 Years | All | 18 | Phase 2 | Denmark |
| 18 | NCT02549170 | April 29, 2016 | 4 November 2019 | Phase III Efficacy, Safety, and Tolerability Study of HYQVIA/HyQvia and GAMMAGARD LIQUID/KIOVIG in CIDP | A 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 Polyradiculoneuropathy | Biological: HYQVIA;Biological: 0.25% albumin placebo solution with rHuPH20;Biological: IGIV | Baxalta now part of Shire | Baxalta Innovations GmbH, now part of Shire | Recruiting | 18 Years | N/A | All | 232 | Phase 3 | United 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 |
| 19 | EUCTR2015-003453-18-DK | 25/11/2015 | 21 May 2018 | Study of the effect and safety of a new immunoglobulin preparation (HyQvia) for subcutaneous usage in patients with Multifocal Motor Neuropathy | A 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 Neuropathy | Multifocal 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- | Rigshospitalet | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Denmark | |||
| 20 | NCT02317562 | November 2015 | 16 December 2017 | Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 | International, Multicentre, Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM Study I10E-1302 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy | Drug: I10E | Laboratoire français de Fractionnement et de Biotechnologies | Not recruiting | 18 Years | N/A | All | 19 | Phase 3 | France;Italy;Spain;Tunisia;Turkey;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT02574962 | August 2015 | 8 August 2016 | Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy | Pilot Study of Acthar® Gel in Chronic Inflammatory Demyelinating Neuropathy | Chronic Inflammatory Demyelinating Polyneuropathy | Drug: H.P. Acthar® Gel | Mamatha Pasnoor, MD | Mallinckrodt | Not recruiting | 18 Years | N/A | Both | 0 | Phase 2 | United States |
| 22 | NCT02293460 | May 2015 | 16 December 2017 | Efficacy and Safety Study of I10E in Treatment of Patients With CIDP | An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy. | Chronic Inflammatory Demyelinating Polyradiculoneuropathy | Drug: I10E | Laboratoire français de Fractionnement et de Biotechnologies | Not recruiting | 18 Years | N/A | All | 43 | Phase 3 | France;Italy;Spain;Tunisia;Turkey;United Kingdom;Morocco | |
| 23 | NCT02414490 | March 2015 | 17 June 2019 | IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements | Intravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER) | Chronic Inflammatory Demyelinating Polyneuropathy | Drug: Intravenous Immunoglobulin | University of Minnesota - Clinical and Translational Science Institute | BriovaRx Infusion Services;CSL Behring | Not recruiting | 18 Years | 85 Years | All | 30 | Phase 4 | United States |
| 24 | NCT02372149 | February 2015 | 21 November 2016 | IVIg for Demyelination in Diabetes Mellitus | Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study | Peripheral Neuropathy;Diabetes Mellitus;Chronic Inflammatory Demyelinating Polyneuropathy | Drug: 10% intravenous immunoglobulin (IVIg);Drug: 0.9% sodium chloride | University of Toronto | University Health Network, Toronto | Recruiting | 18 Years | N/A | Both | 25 | Phase 4 | Canada |
| 25 | NCT02404298 | February 2015 | 18 June 2018 | Transcriptome Analysis of the Peripheral Blood in CIDP | Identification of the Mechanisms of Action of Intravenous Immunoglobulins in CIDP by Analysis of the Genetic Expression Profile in Blood Mononuclear Cells | Chronic Inflammatory Demyelinating Polyradiculoneuropathy;Autoimmune Diseases;Clarkson Syndrome;Muscular Autoimmune Disorders | Drug: IVIg | Assistance Publique - Hôpitaux de Paris | Not recruiting | 18 Years | N/A | All | 50 | N/A | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2013-005558-31-GB | 08/01/2015 | 10 July 2017 | Extension of the international study on efficacy and safety of I10E in CIDP patients | International, 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 2 | Chronic 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 BIOTECHNOLOGIES | Authorised | Female: yes Male: yes | 30 | Phase 3 | France;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | |||
| 27 | EUCTR2012-005150-34-NL | 18/11/2014 | 7 December 2015 | Dose response study of intravenous immunoglobulin in CIDP | Dose response trial of IV immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy | Chronic 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 MC | Authorised | Female: yes Male: yes | 17 | Netherlands | ||||
| 28 | EUCTR2013-005557-73-GB | 21/10/2014 | 30 April 2019 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E in initial and maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic 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 BIOTECHNOLOGIES | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | |||
| 29 | NCT02465359 | September 2014 | 6 May 2019 | Subcutaneous Immunoglobulin for CIDP | A Study of Subcutaneous Immunoglobulin as Chronic Treatment for Patients With Chronic Inflammatory Demyelinating Polyneuropathy | Chronic Inflammatory Demyelinating Polyneuropathy | Drug: Immune Globulin Subcutaneous (Human) | University of South Florida | CSL Behring | Not recruiting | 18 Years | 80 Years | All | 20 | N/A | United States |
| 30 | NCT02027701 | July 30, 2014 | 8 January 2018 | Extension 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_3003 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP);Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Biological: IgPro20 | CSL Behring | Not recruiting | 18 Years | N/A | All | 82 | Phase 3 | United States;Australia;Canada;Czechia;France;Germany;Italy;Japan;Netherlands;Spain;United Kingdom;Czech Republic;Finland | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2013-004988-32-NL | 22/01/2014 | 16 January 2017 | Pharmacokinetics of IVIg treatment in patients with CIDP | Rotterdam Observational Study in CIDP of Pharmacokinetics of Intravenous ?-globulin - ROCKY-1 | Chronic Inflammatory Demyelinating Polyneuropathy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kiovig Product Name: Kiovig Pharmaceutical Form: Solution for injection/infusion | Erasmus MC | Not Recruiting | Female: yes Male: yes | Phase 4 | Netherlands | ||||
| 32 | JPRN-JapicCTI-142471 | 10/1/2014 | 2 April 2019 | Phase 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 LIMITED | 20 | 74 | BOTH | 30 | Phase 3 | |||
| 33 | JPRN-JapicCTI-142472 | 10/1/2014 | 2 April 2019 | Phase 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 LIMITED | 20 | 74 | BOTH | 5 | Phase 3 | |||
| 34 | NCT02111590 | January 2014 | 28 September 2015 | Immunoglobulin Dosage and Administration Form in CIDP and MMN | The Influence of Immunoglobulin Dosage and Administration on Development of Hemolytic Anemia and Variation on Muscle Strength in Patients With CIDP and MMN | Chronic Inflammatory Demyelinating Polyneuropathy;Multifocal Motor Neuropathy;Hemolytic Anemia | Drug: Immunoglobulins | Rigshospitalet, Denmark | Aarhus University Hospital;Octapharma Pharmazeutika Produktionsges.m.b.H. | Not recruiting | 18 Years | 80 Years | Both | 36 | N/A | Denmark |
| 35 | NCT01951924 | December 2013 | 8 August 2016 | LIME 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 Neuropathy | 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) | Laboratoire français de Fractionnement et de Biotechnologies | TFS Trial Form Support | Not recruiting | 18 Years | 80 Years | Both | 23 | Phase 3 | France;Italy;Spain;United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT02494505 | November 18, 2013 | 25 March 2019 | Interest of Mycophenolate for CIDP Weaning | Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP) | Chronic Inflammatory Demyelinating Polyradiculopathy | Drug: placebo;Drug: Mycophenolate Mofetil | Assistance Publique - Hôpitaux de Paris | Not recruiting | 18 Years | N/A | All | 40 | Phase 3 | France | |
| 37 | EUCTR2012-001995-12-GB | 01/08/2013 | 21 September 2015 | 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 | 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 | Multifocal 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 BIOTECHNOLOGIES | Authorised | Female: yes Male: yes | 20 | France;Spain;United Kingdom | ||||
| 38 | EUCTR2012-001996-34-FR | 10/07/2013 | 26 August 2013 | A 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 BIOTECHNOLOGIES | Authorised | Female: yes Male: yes | France | |||||
| 39 | EUCTR2013-001428-20-DK | 06/06/2013 | 13 June 2016 | Study of the effect of subcutaneous administration of immunoglobulin in patients with newly diagnosed chronic inflammatory demyelinating polyradiculoneuropathy | Randomized, single-blind crossover study of subcutaneous immunoglobulin in newly diagnosed patients with chronic inflammatory demyelinating polyradiculoneuropathy | Chronic 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 Hospital | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | ||||
| 40 | NCT01824251 | April 2013 | 25 January 2016 | Phase 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 Polyneuropathy | Drug: NPB-01 | Nihon Pharmaceutical Co., Ltd | Not recruiting | 20 Years | 100 Years | Both | 49 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT01827072 | April 2013 | 25 January 2016 | Phase 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 Neuropathy | Drug: NPB-01 | Nihon Pharmaceutical Co., Ltd | Not recruiting | 20 Years | 100 Years | Both | 13 | Phase 3 | Japan | |
| 42 | NCT01625182 | December 22, 2012 | 16 December 2017 | Evaluate 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 Polyradiculoneuropathy | Drug: Fingolimod;Drug: Placebo Comparator | Novartis Pharmaceuticals | Mitsubishi Tanabe Pharma Corporation | Not recruiting | 18 Years | 75 Years | All | 106 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Netherlands;Poland;Spain;United Kingdom;Czech Republic;Norway |
| 43 | JPRN-JapicCTI-121961 | 01/9/2012 | 2 April 2019 | 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) | 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. | 18 | BOTH | 156 | Phase 3 | ||||
| 44 | EUCTR2011-003448-28-DE | 20/04/2012 | 17 October 2016 | Chronic 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 - PATH | Chronic 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 GmbH | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | |||
| 45 | NCT01545076 | March 2012 | 16 July 2018 | Chronic 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 | Chronic Inflammatory Demyelinating Polyneuropathy;Polyradiculoneuropathy | Biological: IgPro20 (low dose);Biological: Placebo;Biological: IgPro10;Biological: IgPro20 (high dose) | CSL Behring | ICON Clinical Research | Not recruiting | 18 Years | N/A | All | 208 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Estonia;Finland;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Spain;United Kingdom;Austria;Czech Republic |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT01225276 | October 2011 | 16 December 2017 | Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP | Double-blind, Placebo-controlled, Randomised, Multicentre, Adaptive, Two-stage Phase 2/3 Study Evaluating Safety and Efficacy of Three Dosages of NewGam in CIDP Patients | Chronic Inflammatory Demyelinating Polyradiculoneuropathy | Drug: NewGam 10%;Drug: Placebo | Octapharma | Not recruiting | 18 Years | N/A | All | 2 | Phase 2/Phase 3 | ||
| 47 | EUCTR2009-017805-13-CZ | 14/07/2011 | 19 February 2018 | PROSPECTIVE, 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-03 | PROSPECTIVE, 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-03 | Chronic 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 AG | Not Recruiting | Female: yes Male: yes | 172 | Phase 2;Phase 3 | Czech Republic;Bulgaria | |||
| 48 | EUCTR2009-017672-24-BE | 13/09/2010 | 21 August 2017 | A 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 GmbH | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Finland;Belgium | |||
| 49 | EUCTR2009-013841-27-DK | 17/12/2009 | 19 March 2012 | A 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 Trial | A 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 Trial | Multifocal 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 GmbH | Not Recruiting | Female: yes Male: yes | 40 | Denmark | ||||
| 50 | EUCTR2009-013930-25-DK | 24/11/2009 | 18 March 2013 | Randomiseret, 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 CIDP | Randomiseret, 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 CIDP | Chronic 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 Neurology | Not Recruiting | Female: yes Male: yes | Denmark | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | NCT00962429 | February 2009 | 19 February 2015 | Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy | Lipoic Acid for Chronic Inflammatory Demyelinating Polyneuropathy—A Randomized, Double-Blind, Placebo Controlled Pilot Study | CIDP;Chronic Inflammatory Demyelinating Polyneuropathy | Drug: lipoic acid | Oregon Health and Science University | Collins Medical Trust | Not recruiting | 18 Years | 80 Years | Both | 8 | Phase 2 | United States |
| 52 | EUCTR2008-005748-18-GB | 02/01/2009 | 19 March 2012 | SAFETY AND TOLERABILITY OF ECULIZUMAB IN THE TREATMENT OF MULTIFOCAL MOTOR NEUROPATHY: AN OPEN LABEL STUDY | SAFETY AND TOLERABILITY OF ECULIZUMAB IN THE TREATMENT OF MULTIFOCAL MOTOR NEUROPATHY: AN OPEN LABEL STUDY | Multifocal 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 Glasgow | Not Recruiting | Female: yes Male: yes | United Kingdom | |||||
| 53 | NCT00666263 | August 2008 | 16 December 2017 | Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy | A 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 Neuropathy | Multifocal Motor Neuropathy | Biological: Immune Globulin Intravenous (human), 10%;Biological: 0.25% human albumin solution (Placebo) | Baxalta now part of Shire | Not recruiting | 18 Years | N/A | All | 50 | Phase 3 | United States;Canada;Denmark;Netherlands;Poland | |
| 54 | NCT00716066 | June 2008 | 9 September 2019 | Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune Diseases | High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases | Autoimmune 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 Transplant | Biological: 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 Transplantation | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) | Recruiting | N/A | 70 Years | All | 40 | Phase 2 | United States |
| 55 | EUCTR2007-000710-37-DE | 10/12/2007 | 19 March 2012 | A 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 AG | Not Recruiting | Female: yes Male: yes | 10 | United Kingdom;Germany;Italy | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | EUCTR2005-001136-76-IT | 09/07/2007 | 7 January 2013 | Double 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 CIDP | Double 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 CIDP | Chronic 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 | KEDRION | Not Recruiting | Female: yes Male: yes | Phase 3 | Italy | ||||
| 57 | JPRN-UMIN000000674 | 2006/08/01 | 2 April 2019 | Cyclosporin A (Neoral) for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) requiring repetitive administration of high-dose intravenous immunoglobulin | Chronic inflammatory demyelinating polyradiculoneuropathy | Cyclosporin 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 Group | 18years-old | 70years-old | Male and Female | 50 | Not selected | Japan | |||
| 58 | NCT00305266 | August 2005 | 19 February 2015 | Study of CIDP Patients During IVIG Treatment | Clinical Study of Intravenous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Drug: intravenous gammaglobulin | University of Aarhus | Not recruiting | 18 Years | 80 Years | Both | 11 | N/A | Denmark | |
| 59 | NCT00278629 | February 21, 2005 | 11 November 2019 | Hematopoietic Stem Cell Transplantation in Chronic Inflammatory Demyelinating Polyneuropathy | Non-myeloablative Autologous Hematopoietic Stem Cell Transplantation in Patients With Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II Trial | Chronic Inflammatory Demyelinating Polyneuropathy | Biological: hematopoietic stem cell transplantation | Northwestern University | Not recruiting | 18 Years | 65 Years | All | 80 | Phase 2 | United States | |
| 60 | NCT01349270 | June 2004 | 19 February 2015 | Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg | Multicentre 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 up | Demyelinating Polyneuropathy | Drug: Immunoglobulin perfusion;Drug: Prednisone | Centre Hospitalier Universitaire de Saint Etienne | Laboratoire français de Fractionnement et de Biotechnologies | Not recruiting | 18 Years | 80 Years | Both | 40 | Phase 3 | France |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT00220740 | April 2004 | 19 October 2017 | Immune 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 Polyneuropathy | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Drug: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified;Drug: Albumin (Human) 25%, United States Pharmacopeia (USP) | Grifols Therapeutics Inc. | Not recruiting | 18 Years | N/A | All | 117 | Phase 3 | United States;Argentina;Canada;Czech Republic;Germany;Israel;Italy;Mexico;Poland;Serbia;Former Serbia and Montenegro | |
| 62 | NCT00099489 | February 2004 | 19 February 2015 | Safety 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 Polyradiculoneuropathy | Drug: Interferon Beta-1a | Biogen Idec | Not recruiting | 18 Years | 75 Years | Both | 67 | Phase 2 | United States;Australia;Canada;United Kingdom | |
| 63 | NCT01236456 | October 2003 | 19 February 2015 | High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating Polyneuropathy | A Phase II Trial of High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating Polyneuropathy | Chronic Inflammatory Demyelinating Polyneuropathy | Drug: Cyclophosphamide | Stony Brook University | Not recruiting | 18 Years | 75 Years | Both | 25 | Phase 2 | United States | |
| 64 | NCT00004772 | September 1992 | 19 February 2015 | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Drug: Immune globulin | National Center for Research Resources (NCRR) | Ohio State University | Not recruiting | 15 Years | N/A | Both | 90 | Phase 3 | ||
| 65 | NCT00001287 | December 1990 | 19 February 2015 | Intravenous 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;Paraproteinemias | Drug: intravenous immunoglobulin (IVIg) | National Institute of Neurological Disorders and Stroke (NINDS) | Not recruiting | N/A | N/A | Both | 60 | Phase 2 | United States |