DDrare: Database of Drug Development for Rare Diseases

Searched query = "Myasthenia", "MG"
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 = 250 mg CK-2017357; 3,4-DAP; 3,4-Diaminopyridine; 3,4-diaminopyridine; 500 mg CK-2017357; ALXN1210; AMIFAMPRIDINA; AMIFAMPRIDINE; ARGX-113; ATG (rabbit); AZA; Abatacept; Abatacept Injection; Acetaminophen; Amifampridine; Amifampridine Phosphate; Anti-C5 antibody; Anti-Thymocyte Globulin; Azathioprine; B-peptide-CRM197 conjugate; BBR 2778; BELIMUMAB; BENLYSTA® (belimumab); BORTEZOMIB; Belimumab; Benlysta (belimumab); Bortezomib; CD19-directed humanised afucosylated monoclonal antibody; CELLCEPT; CFZ533; CV-MG01; Carmustine; CellCept; CellCept 500 mg; CellCept 500 mg film-coated tablets; CellCept 500 mg tablets; CellCept®500 mg tablets; Cellcept; Cellcept 500 mg tablets; Chloride; Cyclophosphamide; Cyclosporine; Cytarabine; DAP; DAS-001; DIFENIDRAMINA CLORIDRATO; Descartes-08; Difenidramina; Diphenhydramine; Diphenhydramine hydrochloride; ECULIZUMAB; EFALIZUMAB; EN101; EPHEDRINE HYDROCHLORIDE; Eculizumab; Efalizumab; Efedrina; Efgartigimod; Ephedrine; Etoposide; FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE; FIRDAPSE 10mg Tablets; Fc- and CDR-modified humanised monoclonal antibody against C5; Firdapse; G-CSF; GAMUNEX 10%; GB-0998 (Intravenous immunoglobulin); GSK1550188; Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF); HBM9161 Injection (340 mg); HBM9161 Injection (680mg and 340 mg); HIZENTRA ®; HUMAN NORMAL IMMUNOGLOBULIN (IV); Hematopoietic Stem Cell Transplantation; Hidrocloruro de efedrina; Human normal immunoglobulin; Human normal immunoglobulin G (IgG); IGIV-C; IMMUNOGLOBULIN G; INEBILIZUMAB; IVIG; IVIg; Immune Globulin (Human), 10% Caprylate/Chromatography Purified; Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C); Immune globulin; Inebilizumab; Influenza vaccine; Intravenous ImmuneGlobulin; Leflunomide; M281; M281 Injection; METILPREDNISOLONE; MONARSEN; MONITOR; MabThera; Mabthera; Magnesium; Magnesium sulfate; Melphalan; Mesna; Mestinon; Methotrexate; Methylprednisolone; Metilprdnisolone; Mutagrip; Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofetil; Mycophenolate mofetil (CellCept); Mycophenolate mofetil [CellCept]; Mycophenolic acid; Other: Laboratory Biomarker Analysis; PARACETAMOLO; PIXANTRONE; PRIVIGEN; PYRIDOSTIGMINE; Paracetamolo; Phosphate; Pixantrone; Prednisolone; Prednisone; Prednisone - Azathioprine; Prednisone alone; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: PLEX; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Plasmapheresis; Procedure: Syngeneic Bone Marrow Transplantation; Procedure: thymectomy plus prednisone; Pyridostigmine; RC18 160mg; RC18 240 mg; RITUXIMAB; ROZANOLIXIZUMAB; RTX; RVT-1401; Rabbit; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Ravulizumab; Rituximab; Rituximab (Rituxan); Rozanolixizumab; SALBUTAMOL SULFATE PH. EUR.; SOLIRIS; Salbutamol; Salbutamol 4Mg Tablet; Salbutamol WZF 4 mg; Sodium Chloride solution; Sodium chloride; Soliris; Subcutaneous immunoglobulins; Sulfate; Symptomatic Treatment, Steroids, Immunosuppressive Agents( azathioprine, tacrolimus, Mycophenolate Mofetil); Symptomatic Treatment, Steroids, Immunosuppressive Agents, Plasma Exchange(PE), Intravenous Immunoglobulin(IVIg); T-peptide-CRM197 conjugate; TAK-079; Tacrolimus; Tacrolimus capsule; Tetanus vaccin; Tofacitinib; Tofacitinib 5 MG; UCB7665; Ultomiris; Velcade; Velcade®; Zilucoplan; Zilucoplan (RA101495); [M281]; [NA]; [TAK-079, TSF-021, TSF79]; [acetominofene]

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	EUCTR2016-001384-37-DE (EUCTR)	07/10/2020	17/12/2018	An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients with Refractory Generalized Myasthenia Gravis (gMG)	An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients with Refractory Generalized Myasthenia Gravis (gMG)	Refractory Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Soliris Product Name: Soliris Product Code: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	17	Phase 3	United States;Canada;Germany;Japan
2	NCT03759366 (ClinicalTrials.gov)	December 21, 2018	26/11/2018	A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)	An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients With Refractory Generalized Myasthenia Gravis	Myasthenia Gravis;Myasthenia Gravis, Juvenile Form;Myasthenia Gravis, Generalized	Drug: Eculizumab	Alexion Pharmaceuticals	NULL	Recruiting	6 Years	17 Years	All	12	Phase 3	United States;Japan
3	EUCTR2013-002191-41-CZ (EUCTR)	08/10/2015	31/08/2015	EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)	Generalized Myasthenia Gravis MedDRA version: 19.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
4	EUCTR2013-002191-41-FI (EUCTR)	01/10/2015	25/09/2015	EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)	Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
5	EUCTR2013-002191-41-NL (EUCTR)	31/08/2015	28/01/2015	EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)	Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Spain;Ireland;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
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
6	EUCTR2013-002191-41-DK (EUCTR)	03/06/2015	16/04/2015	EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)	Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
7	EUCTR2013-002191-41-ES (EUCTR)	29/04/2015	26/01/2015	EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)	Generalized Myasthenia Gravis MedDRA version: 18.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
8	EUCTR2013-003589-15-CZ (EUCTR)	22/04/2015	26/02/2015	STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS	A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)	Generalized Myasthenia Gravis MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden;United Kingdom
9	EUCTR2013-003589-15-HU (EUCTR)	31/03/2015	20/01/2015	STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS	A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)	Generalized Myasthenia Gravis MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
10	EUCTR2013-002191-41-HU (EUCTR)	27/02/2015	21/01/2015	EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)	Generalized Myasthenia Gravis MedDRA version: 18.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
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
11	EUCTR2013-002191-41-DE (EUCTR)	23/12/2014	03/11/2014	EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)	Generalized Myasthenia Gravis MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden
12	EUCTR2013-002191-41-SE (EUCTR)	11/12/2014	13/11/2014	EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)	Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden
13	NCT02301624 (ClinicalTrials.gov)	November 12, 2014	22/11/2014	Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis	A Phase III, Open-label Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)	Refractory Generalized Myasthenia Gravis	Biological: Eculizumab;Drug: Placebo	Alexion Pharmaceuticals	NULL	Completed	18 Years	N/A	All	117	Phase 3	United States;Argentina;Belgium;Brazil;Canada;Czechia;Denmark;Finland;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Turkey;United Kingdom
14	EUCTR2013-002191-41-GB (EUCTR)	27/10/2014	14/07/2014	EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)	Generalized Myasthenia Gravis MedDRA version: 19.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Spain;Ireland;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
15	EUCTR2013-002191-41-BE (EUCTR)	17/10/2014	02/09/2014	EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)	Generalized Myasthenia Gravis MedDRA version: 18.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden
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
16	EUCTR2013-002191-41-IT (EUCTR)	05/10/2014	29/08/2014	EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS	A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)	Generalized Myasthenia Gravis MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden
17	EUCTR2013-003589-15-NL (EUCTR)	09/09/2014	24/02/2014	STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS	A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)	Generalized Myasthenia Gravis MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Germany;Netherlands;Japan;Sweden
18	EUCTR2013-003589-15-FI (EUCTR)	04/06/2014	09/05/2014	STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS	A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)	Generalized Myasthenia Gravis MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden
19	EUCTR2013-003589-15-BE (EUCTR)	28/05/2014	10/02/2014	STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS	A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)	Generalized Myasthenia Gravis MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
20	EUCTR2013-003589-15-FR (EUCTR)	20/05/2014	17/06/2015	STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS	A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)	Generalized Myasthenia Gravis MedDRA version: 18.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92		United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
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
21	EUCTR2013-003589-15-DK (EUCTR)	29/04/2014	04/03/2014	STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS	A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)	Generalized Myasthenia Gravis MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden
22	EUCTR2013-003589-15-GR (EUCTR)	29/04/2014	31/03/2014	STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS	A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)	Generalized Myasthenia Gravis MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden
23	EUCTR2013-003589-15-DE (EUCTR)	07/04/2014	20/12/2013	STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS	A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)	Generalized Myasthenia Gravis MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden
24	EUCTR2013-003589-15-ES (EUCTR)	24/02/2014	27/12/2013	STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS	A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)	Generalized Myasthenia Gravis MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden
25	EUCTR2013-003589-15-IT (EUCTR)	11/02/2014	17/12/2013	STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS	A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)	Generalized Myasthenia Gravis MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden
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
26	EUCTR2013-003589-15-SE (EUCTR)	03/02/2014	16/12/2013	STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS	A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)	Generalized Myasthenia Gravis MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
27	EUCTR2013-003589-15-GB (EUCTR)	03/02/2014	17/12/2013	STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS	A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)	Generalized Myasthenia Gravis MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 3	United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
28	NCT01997229 (ClinicalTrials.gov)	December 2013	18/11/2013	Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)	Refractory Generalized Myasthenia Gravis	Biological: Eculizumab;Drug: Placebo	Alexion Pharmaceuticals	NULL	Completed	18 Years	N/A	All	125	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Turkey;United Kingdom;Czech Republic
29	EUCTR2009-014669-13-GB (EUCTR)	29/12/2009	23/10/2009	A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients with Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment with Immunosuppressants. - C08-001	A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients with Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment with Immunosuppressants. - C08-001	Generalized Myasthenia Gravis (gMG) MedDRA version: 12.0;Level: LLT;Classification code 10028417;Term: Myasthenia gravis	Trade Name: SOLIRIS Product Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	Alexion Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	24		United Kingdom
30	NCT00727194 (ClinicalTrials.gov)	October 2008	30/7/2008	Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis	A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients With Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment With Immunosuppressants	Myasthenia Gravis	Drug: eculizumab;Drug: Placebo	Alexion Pharmaceuticals	NULL	Terminated	18 Years	80 Years	All	14	Phase 2	United States;Canada;United Kingdom

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

EUCTR2016-001384-37-DE
(EUCTR)

07/10/2020

17/12/2018

An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients with Refractory Generalized Myasthenia Gravis (gMG)

Refractory Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Soliris
Product Name: Soliris
Product Code: Soliris
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Canada;Germany;Japan

NCT03759366
(ClinicalTrials.gov)

December 21, 2018

26/11/2018

A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)

An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients With Refractory Generalized Myasthenia Gravis

Myasthenia Gravis;Myasthenia Gravis, Juvenile Form;Myasthenia Gravis, Generalized

Drug: Eculizumab

Alexion Pharmaceuticals

NULL

Recruiting

6 Years

17 Years

All

Phase 3

United States;Japan

EUCTR2013-002191-41-CZ
(EUCTR)

08/10/2015

31/08/2015

EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)

Generalized Myasthenia Gravis
MedDRA version: 19.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden

EUCTR2013-002191-41-FI
(EUCTR)

01/10/2015

25/09/2015

EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)

Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden

EUCTR2013-002191-41-NL
(EUCTR)

31/08/2015

28/01/2015

EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Spain;Ireland;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden

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

EUCTR2013-002191-41-DK
(EUCTR)

03/06/2015

16/04/2015

EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

EUCTR2013-002191-41-ES
(EUCTR)

29/04/2015

26/01/2015

EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)

Generalized Myasthenia Gravis
MedDRA version: 18.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden

EUCTR2013-003589-15-CZ
(EUCTR)

22/04/2015

26/02/2015

STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Generalized Myasthenia Gravis
MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: SOLIRIS
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden;United Kingdom

EUCTR2013-003589-15-HU
(EUCTR)

31/03/2015

20/01/2015

STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Generalized Myasthenia Gravis
MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: SOLIRIS
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden

EUCTR2013-002191-41-HU
(EUCTR)

27/02/2015

21/01/2015

EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden

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

EUCTR2013-002191-41-DE
(EUCTR)

23/12/2014

03/11/2014

EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden

EUCTR2013-002191-41-SE
(EUCTR)

11/12/2014

13/11/2014

EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)

Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden

NCT02301624
(ClinicalTrials.gov)

November 12, 2014

22/11/2014

Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis

A Phase III, Open-label Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Refractory Generalized Myasthenia Gravis

Biological: Eculizumab;Drug: Placebo

Alexion Pharmaceuticals

NULL

Completed

18 Years

N/A

All

117

Phase 3

United States;Argentina;Belgium;Brazil;Canada;Czechia;Denmark;Finland;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Turkey;United Kingdom

EUCTR2013-002191-41-GB
(EUCTR)

27/10/2014

14/07/2014

EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)

Generalized Myasthenia Gravis
MedDRA version: 19.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Spain;Ireland;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden

EUCTR2013-002191-41-BE
(EUCTR)

17/10/2014

02/09/2014

EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

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

EUCTR2013-002191-41-IT
(EUCTR)

05/10/2014

29/08/2014

EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS

A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG)

Generalized Myasthenia Gravis
MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden

EUCTR2013-003589-15-NL
(EUCTR)

09/09/2014

24/02/2014

STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Germany;Netherlands;Japan;Sweden

EUCTR2013-003589-15-FI
(EUCTR)

04/06/2014

09/05/2014

STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden

EUCTR2013-003589-15-BE
(EUCTR)

28/05/2014

10/02/2014

STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

EUCTR2013-003589-15-FR
(EUCTR)

20/05/2014

17/06/2015

STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Generalized Myasthenia Gravis
MedDRA version: 18.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden

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

EUCTR2013-003589-15-DK
(EUCTR)

29/04/2014

04/03/2014

STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Generalized Myasthenia Gravis
MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden

EUCTR2013-003589-15-GR
(EUCTR)

29/04/2014

31/03/2014

STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Generalized Myasthenia Gravis
MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

EUCTR2013-003589-15-DE
(EUCTR)

07/04/2014

20/12/2013

STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden

EUCTR2013-003589-15-ES
(EUCTR)

24/02/2014

27/12/2013

STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden

EUCTR2013-003589-15-IT
(EUCTR)

11/02/2014

17/12/2013

STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

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

EUCTR2013-003589-15-SE
(EUCTR)

03/02/2014

16/12/2013

STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

EUCTR2013-003589-15-GB
(EUCTR)

03/02/2014

17/12/2013

STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)

Generalized Myasthenia Gravis
MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden

NCT01997229
(ClinicalTrials.gov)

December 2013

18/11/2013

Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

Refractory Generalized Myasthenia Gravis

Biological: Eculizumab;Drug: Placebo

Alexion Pharmaceuticals

NULL

Completed

18 Years

N/A

All

125

Phase 3

United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Turkey;United Kingdom;Czech Republic

EUCTR2009-014669-13-GB
(EUCTR)

29/12/2009

23/10/2009

A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients with Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment with Immunosuppressants. - C08-001

Generalized Myasthenia Gravis (gMG)
MedDRA version: 12.0;Level: LLT;Classification code 10028417;Term: Myasthenia gravis

Trade Name: SOLIRIS
Product Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody

Alexion Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

NCT00727194
(ClinicalTrials.gov)

October 2008

30/7/2008

Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis

A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients With Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment With Immunosuppressants

Myasthenia Gravis

Drug: eculizumab;Drug: Placebo

Alexion Pharmaceuticals

NULL

Terminated

18 Years

80 Years

All

Phase 2

United States;Canada;United Kingdom