DDrare: Database of Drug Development for Rare Diseases

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：145，薬物数：139（DrugBank：23），標的遺伝子数：12，標的パスウェイ数：21］

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: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0.9% sodium chloride; 10% intravenous immunoglobulin (IVIg); 10% liquid formulation of human immunoglobulin; : immunoglobulina umana normale 10% per somministrazione endovenosa; ARGX-113; Acthar; Albumin (Human) 25%, United States Pharmacopeia (USP); Anti-C5 antibody; Anti-Thymocyte Globulin; BIVV020; Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL); Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL); CLORFENAMINA MALEATO; Carmustine; Chloride; Clorfenamina; Clorfenamina maleato; Cyclophosphamide; Cytarabine; Device: Vital EMS+; Dexamethasone; Eculizumab; Efgartigimod PH20 SC; Efgartigimod PH20 SC in stage B; Efgartigimod alfa; Etoposide; FAMPRIDINE; FINGOLIMOD HYDROCHLORIDE; FTY720; FTY720I; Fampridine; Fampyra; Fibrinogen; Fibrinogen concentrate; Fingolimod; Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS); GILENYA 0,5 mg cápsulas duras; Gammanorm; Gilenya; H.P. Acthar® Gel; HIDROCLORURO DE FINGOLIMOD; HUMAN IMMUNOGLOBULIN G; HUMAN NORMAL IMMUNOGLOBULIN; HUMAN NORMAL IMMUNOGLOBULIN (IV); Hematopoietic stem cell transplantation; Hizentra; Hizentra®; Human Immunoglobulin G; Human immunoglobulin G; Human normal 10% immunoglobulin for intravenous administration; Human normal 10% immunoglobulin for intravenous administrationn; Human normal immunoglobulin; Human normal immunoglobulin (SCIg); Human normal immunoglobulin G (IgG > 98% purity); Human normal immunoglobulin for intravenous administration; HyQvia; Hyqvia; I10; I10E; IGIV, 10%; IGVENA*FL 200ML 10G+SET; IMMUNOGLOBULIN G; IMMUNOGLOBULINA UMANA NORMALE per somministrazione endovenosa; IQYMUNE; IVIg; IgPro10; IgPro20; IgPro20 (high dose); IgPro20 (low dose); Immune Globulin 10% Intravenous Solution; Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified; Immune Globulin Intravenous (human), 10%; Immune Globulin Subcutaneous (Human); Immune globulin; Immunoglobulin; Immunoglobulin G; Immunoglobulin perfusion; Immunoglobulina umana normale per somministrazione endovenosa; Immunoglobuline G; Immunoglobulins; Immunoglobulins, normal human, for extravascular adm.; Immunoglobulins, normal human, for intravascular adm.; Intravenous Immunoglobulin; Intravenous immunoglobulin; Intravenous immunoglobulin (IVIg); KIOVIG; KIOVIG 100 mg/ml solution for infusion; Kiovig; Lipoic acid; MABTHERA - 1 FIALA 500 MG 50 ML; MD1003; METILPREDNISOLONE SODIO SUCCINATO; MabThera; Melphalan; Methylprednisolon; Methylprednisolon (Solu-Medrol); Methylprednisolone; Methylprednisolone (Solu-Medrol); Metilprednisolone sodio succinato; NPB-01; NewGam; Other: Fresh Frozen Plasma; Other: Laboratory Biomarker Analysis; PANZYGA; PARACETAMOLO; Paracetamolo; Placebo; Prednisolone; Prednisone; Privigen; Privigen®; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Syngeneic Bone Marrow Transplantation; RHuPH20; RITUXIMAB; ROZANOLIXIZUMAB; RVG 51680; RVG 56083; Rituximab; Rituximab (genetical recombination); Rozanolixizumab; SOLIRIS; SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML; Sodium Chloride 0.9%; Sodium chloride; Sodium chloride 0.9%; Soliris; Standard of Care; Subcutaneous immunoglobulin; Subcuvia; TACHIPIRINA - 1000 MG COMPRESSE 8 COMPRESSE; TRIMETON - 10 MG/1 ML SOLUZIONE INIETTABILE 5 FIALE 1 ML; UCB7665; Vivaglobin; [Clorfenamina maleato]; [Metilprednisolone sodio succinato]; [Paracetamolo]; [Rituximab]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2020-002438-34-DK (EUCTR)	19/08/2020	11/06/2020	Fampridine for treatment of functional disability in patients with immune mediated polyneuropathy	Fampridine for treatment of residual neurological deficits in patients treated with immunoglobulins for chronic inflammatory demyelinating polyneuropathy	Chronic inflammatory demyelinating polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10072650;Term: CIDP;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Fampyra Product Name: Fampyra INN or Proposed INN: FAMPRIDINE	Department of Neurology, Odense University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	Denmark
2	EUCTR2015-000828-28-NL (EUCTR)	26/07/2016	30/11/2015	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	UMC Utrecht	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 3	Netherlands
3	NCT02111590 (ClinicalTrials.gov)	January 2014	9/4/2014	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.	Completed	18 Years	80 Years	Both	36	N/A	Denmark
4	EUCTR2007-000710-37-IT (EUCTR)	04/10/2007	12/02/2008	A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - ND	A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - ND	Maintenance treatment with subcutaneous immunoglobulin (Vivaglobin) in patients with MMN. MedDRA version: 9.1;Level: LLT;Classification code 10036105;Term: Polyneuropathy	Trade Name: Vivaglobin INN or Proposed INN: Immunoglobulins, normal human, for extravascular adm.	CSL Behring AG	NULL	Not Recruiting			Female: yes Male: yes	10		United Kingdom;Germany;Italy
5	EUCTR2005-001136-76-IT (EUCTR)	09/07/2007	07/09/2007	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 INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.	KEDRION	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2020-002438-34-DK
(EUCTR)

19/08/2020

11/06/2020

Fampridine for treatment of functional disability in patients with immune mediated polyneuropathy

Fampridine for treatment of residual neurological deficits in patients treated with immunoglobulins for chronic inflammatory demyelinating polyneuropathy

Chronic inflammatory demyelinating polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10072650;Term: CIDP;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Fampyra
Product Name: Fampyra
INN or Proposed INN: FAMPRIDINE

Department of Neurology, Odense University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark

EUCTR2015-000828-28-NL
(EUCTR)

26/07/2016

30/11/2015

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

UMC Utrecht

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Netherlands

NCT02111590
(ClinicalTrials.gov)

January 2014

9/4/2014

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.

Completed

18 Years

80 Years

Both

N/A

Denmark

EUCTR2007-000710-37-IT
(EUCTR)

04/10/2007

12/02/2008

A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - ND

Maintenance treatment with subcutaneous immunoglobulin (Vivaglobin) in patients with MMN.
MedDRA version: 9.1;Level: LLT;Classification code 10036105;Term: Polyneuropathy

Trade Name: Vivaglobin
INN or Proposed INN: Immunoglobulins, normal human, for extravascular adm.

CSL Behring AG

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Germany;Italy

EUCTR2005-001136-76-IT
(EUCTR)

09/07/2007

07/09/2007

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
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.

KEDRION

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Italy