11. 重症筋無力症
［臨床試験数：226，薬物数：172（DrugBank：45），標的遺伝子数：43，標的パスウェイ数：118］
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.
| 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 | EUCTR2020-003230-20-HU (EUCTR) | 01/12/2020 | 01/10/2020 | A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis | An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan | ||
| 2 | NCT04650854 (ClinicalTrials.gov) | December 2020 | 5/11/2020 | A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: Rozanolixizumab | UCB Biopharma SRL | NULL | Not yet recruiting | 18 Years | N/A | All | 230 | Phase 3 | NULL |
| 3 | EUCTR2020-003230-20-GB (EUCTR) | 30/11/2020 | 02/09/2020 | A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis | An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan | ||
| 4 | EUCTR2020-003230-20-DK (EUCTR) | 17/11/2020 | 06/10/2020 | A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis | An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan | ||
| 5 | EUCTR2020-000949-14-FR (EUCTR) | 16/11/2020 | 08/10/2020 | Inebilizumab efficacy and safety in adults with myasthenia gravis | A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITHOPEN-LABEL PERIOD TO EVALUATE THE EFFICACYAND SAFETY OF INEBILIZUMAB IN ADULTS WITHMYASTHENIA GRAVIS - Myasthenia Gravis INebilizumab Trial (MINT) | Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Inebilizumab INN or Proposed INN: INEBILIZUMAB Other descriptive name: CD19-directed humanised afucosylated monoclonal antibody | Viela Bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 3 | Ukraine;United States;Belarus;Finland;Spain;Guatemala;Turkey;Russian Federation;Israel;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Germany;Japan;China | ||
| 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 | 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 | ||
| 7 | NCT04226170 (ClinicalTrials.gov) | September 30, 2020 | 9/1/2020 | Study of Pyridostigmine With Ondansetron in Subjects With Anti-AchR Positive Myasthenia Gravis | A Phase II, Study to Evaluate the Safety and Tolerability of Pyridostigmine When Given With Ondansetron to Subjects With Anti-AchR Positive Myasthenia Gravis | Myasthenia Gravis | Drug: DAS-001 | DAS-MG, Inc | NULL | Not yet recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States |
| 8 | NCT04524273 (ClinicalTrials.gov) | August 30, 2020 | 10/8/2020 | Myasthenia Gravis Inebilizumab Trial | A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis | Myasthenia Gravis | Drug: inebilizumab;Drug: IV Placebo | Viela Bio | NULL | Recruiting | 18 Years | N/A | All | 252 | Phase 3 | United States |
| 9 | EUCTR2019-003383-47-IT (EUCTR) | 12/08/2020 | 25/09/2020 | A Study to Investigate the Safety, Tolerability, and Efficacy of TAK-079 in Participants With Generalized Myasthenia Gravis | A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis - - | 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] - Immune System Diseases [C20] | Product Name: TAK-079 Product Code: [TAK-079, TSF-021, TSF79] INN or Proposed INN: TAK-079 Other descriptive name: TAK-079 Product Name: metilprdnisolone Product Code: [-] INN or Proposed INN: METILPREDNISOLONE Other descriptive name: methylprednisolone Product Name: difenidramina Product Code: [NA] INN or Proposed INN: DIFENIDRAMINA CLORIDRATO Other descriptive name: diphenhydramine hydrochloride Product Name: paracetamolo Product Code: [acetominofene] INN or Proposed INN: PARACETAMOLO Other descriptive name: acetaminophen | MILLENNIUM PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Serbia;Canada;Spain;Poland;Italy | ||
| 10 | NCT04346888 (ClinicalTrials.gov) | July 23, 2020 | 13/4/2020 | A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamic and Pharmacokinetic of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis | Myasthenia Gravis | Drug: HBM9161 Injection (680mg and 340 mg);Drug: Placebos;Drug: HBM9161 Injection (340 mg) | Harbour BioMed (Guangzhou) Co. Ltd. | NULL | Recruiting | 18 Years | 99 Years | All | 30 | Phase 2 | China |
| 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 | JPRN-JapicCTI-205350 | 20/7/2020 | 01/07/2020 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | Generalized myasthenia gravis | Intervention name : Rozanolixizumab INN of the intervention : rozanolixizumab Dosage And administration of the intervention : Rozanolixizumab will be administered by subcutaneous infusion in 2 different dosages (dose 1 and dose 2) in dosage regimen 1 and 2. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | UCB Japan Co., Ltd. | NULL | pending | 18 | BOTH | 18 | Phase 3 | Japan, Asia except Japan, North America, Europe | |
| 12 | EUCTR2018-003243-39-PT (EUCTR) | 15/06/2020 | 06/02/2020 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | 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: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Portugal;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 13 | NCT04431895 (ClinicalTrials.gov) | June 11, 2020 | 12/6/2020 | Safety And Efficacy Of Tofacitinib In Patients With Refractory Myasthenia Gravis: A Pilot Study | A Prospective,Single-center,Single-Arm,Single-Blind Pilot Study To Investigate The Efficacy Of Tofacitinib In Patients With Refractory Myasthenia Gravis | Myasthenia Gravis, Generalized | Drug: Tofacitinib 5 MG | Huashan Hospital | NULL | Recruiting | 18 Years | 60 Years | All | 5 | Early Phase 1 | China |
| 14 | EUCTR2019-001564-30-ES (EUCTR) | 13/05/2020 | 11/11/2019 | A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia Gravis | A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Zilucoplan INN or Proposed INN: Zilucoplan | Ra Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United Kingdom;Japan;Italy;United States;France;Canada;Spain;Norway;Germany | ||
| 15 | EUCTR2019-001565-33-ES (EUCTR) | 13/05/2020 | 14/01/2020 | Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis | A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Zilucoplan INN or Proposed INN: Zilucoplan | Ra Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;France;Canada;Spain;Norway;Germany;United Kingdom;Japan;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 |
| 16 | EUCTR2019-000969-21-DE (EUCTR) | 20/04/2020 | 05/11/2019 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 276 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 17 | EUCTR2019-000969-21-PL (EUCTR) | 12/04/2020 | 20/02/2020 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 276 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany | ||
| 18 | NCT04302103 (ClinicalTrials.gov) | April 2020 | 6/3/2020 | A Study of TACI(Transmembrane Activator and Calcium-modulator and Cyclophilin Ligand (CAML) Interactor)-Antibody Fusion Protein Injection (RC18) in Subjects With Systemic Myasthenia Gravis | A Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Systemic Myasthenia Gravis | Systemic Myasthenia Gravis | Biological: RC18 160mg;Biological: RC18 240 mg | RemeGen | NULL | Recruiting | 18 Years | 70 Years | All | 20 | Phase 2 | China |
| 19 | JPRN-JapicCTI-205207 | 11/3/2020 | 04/03/2020 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | Generalized myasthenia gravis | Intervention name : Rozanolixizumab INN of the intervention : rozanolixizumab Dosage And administration of the intervention : Rozanolixizumab will be administered by subcutaneous infusion in 2 different dosages (dose 1 and dose 2) in dosage regimen 1 and 2. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | UCB Japan Co., Ltd. | NULL | pending | 18 | BOTH | 18 | Phase 3 | Japan, Asia except Japan, North America, Europe | |
| 20 | EUCTR2019-000969-21-CZ (EUCTR) | 24/02/2020 | 20/12/2019 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 276 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 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 | EUCTR2019-000969-21-ES (EUCTR) | 14/02/2020 | 11/11/2019 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 22 | EUCTR2018-003243-39-GB (EUCTR) | 11/02/2020 | 08/10/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | 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: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 23 | NCT04159805 (ClinicalTrials.gov) | January 14, 2020 | 8/11/2019 | A Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Participants With Generalized Myasthenia Gravis | A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis | Myasthenia Gravis | Drug: TAK-079;Drug: TAK-079 Placebo | Takeda | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States;Canada;Italy;Poland;Serbia;Spain |
| 24 | EUCTR2019-000969-21-GB (EUCTR) | 06/01/2020 | 15/10/2019 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 276 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 25 | EUCTR2018-003243-39-CZ (EUCTR) | 02/01/2020 | 13/09/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of | |||
| 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 | NCT04225871 (ClinicalTrials.gov) | December 23, 2019 | 2/10/2019 | Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis | A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: zilucoplan (RA101495) | Ra Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 200 | Phase 3 | United States;Canada;France;Germany;Italy;Japan;Norway;Spain;United Kingdom |
| 27 | EUCTR2019-000968-18-PL (EUCTR) | 19/12/2019 | 09/07/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany | ||
| 28 | NCT04146051 (ClinicalTrials.gov) | December 4, 2019 | 29/10/2019 | Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG) | Autologous T-Cells Expressing A Chimeric Antigen Receptor Directed To B-Cell Maturation Antigen (BCMA) In Patients With Generalized Myasthenia Gravis (MG) | Myasthenia Gravis, Generalized | Drug: Descartes-08 | Cartesian Therapeutics | NULL | Recruiting | 18 Years | N/A | All | 18 | Phase 1;Phase 2 | United States |
| 29 | EUCTR2019-000968-18-DE (EUCTR) | 15/11/2019 | 10/07/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 30 | EUCTR2019-000968-18-GB (EUCTR) | 14/11/2019 | 28/06/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients with Generalized Myasthenia Gravis. - MycarinGstudy | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Taiwan;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;United States;Hong Kong;Spain;Russian Federation;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 |
| 31 | EUCTR2019-000968-18-CZ (EUCTR) | 11/11/2019 | 13/08/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 32 | EUCTR2019-000969-21-DK (EUCTR) | 07/11/2019 | 17/10/2019 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 276 | Phase 3 | United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 33 | NCT04182984 (ClinicalTrials.gov) | November 4, 2019 | 26/11/2019 | TheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world Study | TheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world Study | Ocular Myasthenia Gravis | Drug: Symptomatic Treatment, Steroids, Immunosuppressive Agents( azathioprine, tacrolimus, Mycophenolate Mofetil) | Tang-Du Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 200 | China | |
| 34 | EUCTR2019-001565-33-GB (EUCTR) | 30/10/2019 | 01/11/2019 | Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis | A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Zilucoplan INN or Proposed INN: Zilucoplan | Ra Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Spain;Norway;Germany;Japan;Italy;United Kingdom | ||
| 35 | EUCTR2019-001564-30-GB (EUCTR) | 29/10/2019 | 01/11/2019 | A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia Gravis | A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Zilucoplan INN or Proposed INN: Zilucoplan | Ra Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | France;United States;Canada;Spain;Norway;Germany;Japan;Italy;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 |
| 36 | NCT04124965 (ClinicalTrials.gov) | October 29, 2019 | 11/10/2019 | A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: Rozanolixizumab | UCB Biopharma SRL | NULL | Enrolling by invitation | 18 Years | N/A | All | 276 | Phase 3 | United States;Canada;Czechia;Denmark;France;Germany;Italy;Japan;Poland;Russian Federation;Spain;Taiwan |
| 37 | EUCTR2019-000968-18-BE (EUCTR) | 14/10/2019 | 14/08/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. - MycarinGstudy | 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] | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | |||
| 38 | EUCTR2018-003243-39-AT (EUCTR) | 09/10/2019 | 26/04/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | 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] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | Portugal;United States;Spain;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 39 | NCT04115293 (ClinicalTrials.gov) | October 1, 2019 | 2/10/2019 | Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis | A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis | Myasthenia Gravis, Generalized | Drug: zilucoplan (RA101495);Drug: Placebo | Ra Pharmaceuticals | NULL | Recruiting | 18 Years | 75 Years | All | 130 | Phase 3 | United States;Canada;France;Germany;Italy;Japan;Norway;Spain;United Kingdom |
| 40 | EUCTR2019-000968-18-HU (EUCTR) | 25/09/2019 | 23/07/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany | |||
| 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 |
| 41 | EUCTR2018-003243-39-DK (EUCTR) | 20/09/2019 | 22/05/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | 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: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Portugal;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 42 | EUCTR2019-000968-18-DK (EUCTR) | 06/09/2019 | 24/06/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 43 | EUCTR2019-000968-18-ES (EUCTR) | 28/08/2019 | 12/09/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. | A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. - MycarinGstudy | 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] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 44 | NCT03896295 (ClinicalTrials.gov) | August 6, 2019 | 28/3/2019 | An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: M281 | Momenta Pharmaceuticals, Inc. | NULL | Suspended | 18 Years | N/A | All | 60 | Phase 2 | United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom |
| 45 | EUCTR2018-003618-41-BE (EUCTR) | 05/08/2019 | 05/04/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | Generalized Myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;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 |
| 46 | EUCTR2018-003243-39-DE (EUCTR) | 30/07/2019 | 25/03/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | 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: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Portugal;Spain;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 47 | ChiCTR1900024644 | 2019-07-30 | 2019-07-19 | Investigation of the clinical heterogeneity of childhood onset myasthenia gravis in China | Investigation of mechanism of clinical heterogeneity of childhood onset myasthenia gravis and precision therapeutic strategies in China | maysthenia gravis | routine group:routine therapy;FK506 group:routine+FK506 therapy;RTX group:routine+RTX therapy;Thymectomy group:routine+Thymectomy therapy;FK506+Thymectomy group:routine+FK506+Thymectomy therapy;RTX+Thymectomy group:routine+RTX+Thymectomy therapy; | Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | NULL | Pending | Both | routine group:20;FK506 group:20;RTX group:20;Thymectomy group:20;FK506+Thymectomy group:20;RTX+Thymectomy group:20; | N/A | China | ||
| 48 | EUCTR2018-003243-39-NL (EUCTR) | 22/07/2019 | 01/05/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Canada;Spain;Denmark;Austria;Israel;Germany;Netherlands;Japan;Italy;Switzerland;Korea, Republic of | |||
| 49 | EUCTR2018-003618-41-PL (EUCTR) | 05/07/2019 | 13/05/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | 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] - Musculoskeletal Diseases [C05] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 2 | United States;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy | ||
| 50 | EUCTR2018-003618-41-DE (EUCTR) | 01/07/2019 | 29/03/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | Generalized Myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Germany;Italy;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 |
| 51 | EUCTR2018-002133-37-NL (EUCTR) | 06/06/2019 | 26/09/2018 | A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Japan;Sweden | |||
| 52 | EUCTR2018-003618-41-GB (EUCTR) | 05/06/2019 | 28/03/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | 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] - Musculoskeletal Diseases [C05] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom | ||
| 53 | NCT03971422 (ClinicalTrials.gov) | June 3, 2019 | 29/5/2019 | A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: Rozanolixizumab;Other: Placebo | UCB Biopharma SRL | NULL | Recruiting | 18 Years | N/A | All | 240 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Poland;Russian Federation;Spain;Taiwan;United Kingdom |
| 54 | NCT03863080 (ClinicalTrials.gov) | May 21, 2019 | 20/2/2019 | A Study of RVT-1401 in Myasthenia Gravis (MG) Patients | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis Patients | Myasthenia Gravis | Drug: RVT-1401;Drug: Placebo | Immunovant Sciences GmbH | NULL | Recruiting | 18 Years | N/A | All | 21 | Phase 2 | United States;Canada |
| 55 | EUCTR2018-003243-39-ES (EUCTR) | 21/05/2019 | 27/05/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Canada;Spain;Denmark;Austria;Israel;Netherlands;Germany;Japan;Italy;Switzerland;Korea, Republic of | |||
| 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 |
| 56 | EUCTR2018-002132-25-NL (EUCTR) | 30/04/2019 | 26/09/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Sweden | ||
| 57 | NCT03772587 (ClinicalTrials.gov) | April 10, 2019 | 10/12/2018 | A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: M281;Other: Placebo | Momenta Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | All | 69 | Phase 2 | United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom |
| 58 | EUCTR2018-003618-41-ES (EUCTR) | 02/04/2019 | 12/04/2019 | To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis | Generalized Myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Momenta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Germany;Italy;United Kingdom | |||
| 59 | NCT03914638 (ClinicalTrials.gov) | April 1, 2019 | 11/4/2019 | Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia Gravis | Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia Gravis | Myasthenia Gravis | Drug: Salbutamol 4Mg Tablet;Drug: Placebo oral capsule | University of Aarhus | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2;Phase 3 | Denmark |
| 60 | EUCTR2019-000895-40-DK (EUCTR) | 28/03/2019 | 26/02/2019 | Beta-agonist Efficacy and Tolerability as Adjuvant therapy in Myasthenia Gravis | Beta-agonist Efficacy and Tolerability as Adjuvant therapy in Myasthenia Gravis - BETA-MG | 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] - Musculoskeletal Diseases [C05] | Trade Name: Salbutamol WZF 4 mg INN or Proposed INN: Salbutamol Other descriptive name: SALBUTAMOL SULFATE PH. EUR. | Aarhus University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 3 | Denmark | ||
| 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 |
| 61 | NCT03920293 (ClinicalTrials.gov) | March 26, 2019 | 16/4/2019 | Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Biological: Ravulizumab;Drug: Placebo | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 175 | Phase 3 | United States;Austria;Canada;Czechia;Denmark;France;Germany;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Spain;Switzerland |
| 62 | EUCTR2018-002247-28-BE (EUCTR) | 18/03/2019 | 05/12/2018 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 63 | NCT03770403 (ClinicalTrials.gov) | March 1, 2019 | 16/11/2018 | A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness. | A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness | Generalized Myasthenia Gravis | Biological: ARGX-113 | argenx | NULL | Active, not recruiting | 18 Years | N/A | All | 151 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Serbia |
| 64 | EUCTR2018-002247-28-PL (EUCTR) | 27/02/2019 | 31/12/2018 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;France;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy | ||
| 65 | EUCTR2018-002133-37-DK (EUCTR) | 26/02/2019 | 13/11/2018 | A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;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 |
| 66 | EUCTR2018-002132-25-CZ (EUCTR) | 25/02/2019 | 01/11/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 67 | EUCTR2018-002133-37-CZ (EUCTR) | 25/02/2019 | 02/11/2018 | A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;Netherlands;Japan | |||
| 68 | EUCTR2018-002132-25-DE (EUCTR) | 22/02/2019 | 12/11/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 69 | EUCTR2018-002133-37-DE (EUCTR) | 22/02/2019 | 12/11/2018 | A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Russian Federation;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan | |||
| 70 | EUCTR2018-002247-28-GB (EUCTR) | 05/02/2019 | 30/11/2018 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 INN or Proposed INN: M281 Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;Italy;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 |
| 71 | EUCTR2018-002247-28-IT (EUCTR) | 04/02/2019 | 04/11/2020 | To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis - VIVACITY | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: M281 Injection Product Code: [M281] INN or Proposed INN: M281 | MOMENTA PHARMACEUTICALS, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy | ||
| 72 | EUCTR2018-002132-25-HU (EUCTR) | 28/01/2019 | 16/11/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 73 | EUCTR2018-002133-37-HU (EUCTR) | 28/01/2019 | 22/11/2018 | A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan;Sweden | |||
| 74 | EUCTR2018-002132-25-BE (EUCTR) | 21/01/2019 | 16/11/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 75 | EUCTR2018-002133-37-BE (EUCTR) | 21/01/2019 | 19/11/2018 | A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Japan;United States;Serbia;Russian Federation;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands | ||
| 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 |
| 76 | EUCTR2018-002132-25-FR (EUCTR) | 15/01/2019 | 29/10/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 77 | 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 |
| 78 | EUCTR2018-002247-28-ES (EUCTR) | 14/12/2018 | 18/01/2019 | To evaluate the efficacy of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis | Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduce of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Momenta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | France;United States;Canada;Poland;Belgium;Spain;Germany;Italy;United Kingdom | |||
| 79 | EUCTR2018-002132-25-DK (EUCTR) | 13/12/2018 | 28/09/2018 | An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 80 | ChiCTR1800017564 | 2018-09-08 | 2018-08-04 | Optimal Timing of Thymectomy in Nonthymomatous Myasthenia Gravis Patients In China: A Follow-up Prospective Study | Optimal Timing of Thymectomy in Nonthymomatous Myasthenia Gravis Patients In China: A Prospective Study | Myasthenia Gravis | Experiment group versus Control group:Thymectomy plus oral prednisone, an immunosuppressant protocol versus Prednisone, or immunosuppressants alone; | The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine | NULL | Pending | 1 | 80 | Both | Experiment group versus Control group:822; | China | |
| 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 |
| 81 | NCT03669588 (ClinicalTrials.gov) | September 5, 2018 | 6/9/2018 | An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness | Generalized Myasthenia Gravis | Biological: ARGX-113;Biological: Placebo | argenx | NULL | Completed | 18 Years | N/A | All | 167 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Serbia;United Kingdom |
| 82 | NCT03579966 (ClinicalTrials.gov) | July 1, 2018 | 5/6/2018 | Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis) | Long Term Safety Study of Amifampridine Phosphate in Patients With MuSK Antibody Positive and AChR (Acetylcholine Receptor) Antibody Positive Myasthenia Gravis | Myasthenia Gravis, MuSK | Drug: Amifampridine Phosphate | Catalyst Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 70 | Phase 3 | United States |
| 83 | NCT03165435 (ClinicalTrials.gov) | July 2018 | 17/5/2017 | A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Active Targeted Immunotherapy CV-MG01 in Patients With Moderate to Severe Myasthenia Gravis. | Myasthenia Gravis, Generalized | Biological: CV-MG01;Biological: Placebo | CuraVac | Aepodia;University Hospital, Antwerp | Withdrawn | 18 Years | N/A | All | 0 | Phase 2;Phase 3 | Belgium;Netherlands |
| 84 | NCT03490539 (ClinicalTrials.gov) | May 7, 2018 | 21/3/2018 | Disease-Modifying Treatments for Myasthenia Gravis | Prospective Multicenter Observational Cohort Study of Comparative Effectiveness of Disease-modifying Treatments for Myasthenia Gravis | Neurological Disorder;Autoimmune Diseases | Drug: Mycophenolate Mofetil;Drug: Azathioprine | Duke University | Beth Israel Deaconess Medical Center;Patient-Centered Outcomes Research Institute | Recruiting | 18 Years | N/A | All | 220 | United States;Canada | |
| 85 | NCT03510546 (ClinicalTrials.gov) | April 9, 2018 | 6/4/2018 | Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia Gravis | Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia Gravis | Myasthenia Gravis | Drug: Pyridostigmine;Drug: Placebo oral capsule | University of Aarhus | Aarhus University Hospital | Recruiting | 18 Years | 90 Years | All | 44 | Phase 4 | Denmark |
| 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 |
| 86 | NCT03304054 (ClinicalTrials.gov) | March 7, 2018 | 28/9/2017 | Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG | A Randomized, Placebo-control, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients With MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis Patients | Myasthenia Gravis, Generalized | Drug: Amifampridine Phosphate;Drug: Placebo Oral Tablet | Catalyst Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | All | 70 | Phase 3 | United States |
| 87 | ChiCTR1900024692 | 2018-01-01 | 2019-07-22 | Comparison of the efficacy of azathioprine and cyclosporine in myasthenia gravis immune modification | Comparison of the efficacy of azathioprine and cyclosporine in myasthenia gravis immune modification | Myasthenia Gravis | eye muscles type:bromopyramine + hormone;eye muscles type:bromopyramine + hormone + azathioprine;eye muscles type:bromopyramine + hormone + cyclosporine;non-eye muscle type:bromopyramine + hormone + azathioprine;non-eye muscle type :bromopyramine + hormone + cyclosporine; | Neurology Department of the 940th Hospital of Joint Logistics Support force of Chinese People's Liberation Army | NULL | Recruiting | 3 | 80 | Both | eye muscles type:20;eye muscles type:20;eye muscles type:20;non-eye muscle type:20;non-eye muscle type :20; | N/A | China |
| 88 | JPRN-JMA-IIA00208 | 01/12/2017 | 10/03/2015 | Efficacy of 3,4-diaminopyridine in the treatment of Lambert-Eaton myasthenia syndrome | Efficacy of 3,4-diaminopyridine in the treatment of Lambert-Eaton myasthenia syndrome | Lambert-Eaton myasthenia syndrome | Intervention type:DRUG. Intervention1:3,4-diaminopyridine, Dose form:POWDER, Route of administration:ORAL. Control intervention1:placebo, Dose form:POWDER, Route of administration:ORAL. | Hiroyuki FUKUDA | NULL | Completed | No Limit | No Limit | BOTH | 3 | NOT APPLICABLE | Japan |
| 89 | EUCTR2017-002599-15-DK (EUCTR) | 07/11/2017 | 07/07/2017 | Effect of pyridostigmine (Mestinon®) on muscle strength in Myasthenia Gravis. | Effect of pyridostigmine (Mestinon®) on muscle strength in Myasthenia Gravis. | 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] - Musculoskeletal Diseases [C05] | Trade Name: Mestinon INN or Proposed INN: pyridostigmine Other descriptive name: PYRIDOSTIGMINE | Aarhus University | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 4 | Denmark | ||
| 90 | NCT03315130 (ClinicalTrials.gov) | October 11, 2017 | 16/10/2017 | Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: zilucoplan (RA101495);Drug: Placebo | Ra Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 85 Years | All | 44 | Phase 2 | United States;Canada |
| 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 |
| 91 | EUCTR2017-000323-27-NL (EUCTR) | 03/08/2017 | 18/04/2017 | A study to evaluate the efficacy of CV-MG01 (Myasterix), a therapy for Myasthenia gravis | A Multi-center, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Myasthenia Gravis Active Targeted Immunotherapy CV-MG01 in Patients with Moderate to Severe Myasthenia Gravis - Myasterix Efficacy Phase 2/3 Study | Myasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack. MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CV-MG01 INN or Proposed INN: Not applicable Other descriptive name: T-peptide-CRM197 conjugate INN or Proposed INN: Not applicable Other descriptive name: B-peptide-CRM197 conjugate | CuraVac Europe SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 66 | Phase 2;Phase 3 | Belgium;Netherlands | ||
| 92 | EUCTR2017-000323-27-BE (EUCTR) | 19/06/2017 | 13/04/2017 | A study to evaluate the efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis | A Multi-center, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Myasthenia Gravis Active Targeted Immunotherapy CV-MG01 in Patients with Moderate to Severe Myasthenia Gravis - Myasterix Efficacy Phase 2/3 Study | Myasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack. MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CV-MG01 INN or Proposed INN: Not applicable Other descriptive name: T-peptide-CRM197 conjugate INN or Proposed INN: Not applicable Other descriptive name: B-peptide-CRM197 conjugate | CuraVac Europe SA | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2;Phase 3 | Belgium;Netherlands | ||
| 93 | EUCTR2016-002698-36-CZ (EUCTR) | 26/05/2017 | 03/04/2017 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: rozanolixizumab Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany | ||
| 94 | EUCTR2016-002698-36-ES (EUCTR) | 25/05/2017 | 31/03/2017 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: UCB7665 Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany | ||
| 95 | EUCTR2016-002698-36-DK (EUCTR) | 19/05/2017 | 07/04/2017 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany | |||
| 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 |
| 96 | NCT03052751 (ClinicalTrials.gov) | May 15, 2017 | 10/2/2017 | Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis | Myasthenia Gravis | Drug: UCB7665;Other: Placebo | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 43 | Phase 2 | United States;Belgium;Canada;Czechia;Denmark;Germany;Spain |
| 97 | NCT03059888 (ClinicalTrials.gov) | April 12, 2017 | 17/2/2017 | Trial of Orencia in Patients With Myasthenia Gravis | Pilot Trial of Orencia in Myasthenia Gravis Patients Inadequately Responsive to Conventional Immunotherapy | Myasthenia Gravis | Drug: Abatacept Injection | Johns Hopkins University | Bristol-Myers Squibb | Terminated | 16 Years | 85 Years | All | 6 | Early Phase 1 | United States |
| 98 | NCT03062631 (ClinicalTrials.gov) | February 20, 2017 | 21/2/2017 | Treatment Use of 3,4 Diaminopyridine in Congenital Myasthenia and Lambert-Eaton Syndrome | Treatment Use of 3,4 Diaminopyridine in Congenital Myasthenia and Lambert-Eaton Syndrome | Congenital Myasthenic Syndrome;Lambert-Eaton Myasthenic Syndrome | Drug: 3,4-Diaminopyridine | Ricardo Maselli | Jacobus Pharmaceutical | Available | 3 Months | 75 Years | All | United States | ||
| 99 | EUCTR2016-002698-36-DE (EUCTR) | 09/02/2017 | 28/11/2016 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: rozanolixizumab Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany | ||
| 100 | NCT04101578 (ClinicalTrials.gov) | February 8, 2017 | 16/9/2019 | Clinical Prognosis and Progression of Myasthenia Gravis Patients | Prospective Observational Trial to Evaluate Clinical Prognosis and the Risk Factors for Progression for Myasthenia Gravis Patients | Myasthenia Gravis | Drug: Symptomatic Treatment, Steroids, Immunosuppressive Agents, Plasma Exchange(PE), Intravenous Immunoglobulin(IVIg) | Da, Yuwei, M.D. | NULL | Recruiting | 15 Years | N/A | All | 2000 | China | |
| 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 |
| 101 | EUCTR2016-002698-36-BE (EUCTR) | 30/01/2017 | 29/11/2016 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: rozanolixizumab Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;Czech Republic;Canada;Spain;Belgium;Denmark;Germany | ||
| 102 | NCT02965573 (ClinicalTrials.gov) | December 30, 2016 | 20/10/2016 | A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness | A Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness | Myasthenia Gravis | Biological: ARGX-113;Drug: Placebo | argenx | Quintiles, Inc. | Completed | 18 Years | N/A | All | 24 | Phase 2 | United States;Belgium;Canada;Italy;Netherlands;Poland;Spain;Sweden |
| 103 | EUCTR2016-002938-73-NL (EUCTR) | 08/12/2016 | 03/10/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | Myasthenia Gravis who have Generalized Muscle Weakness MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden | ||
| 104 | EUCTR2016-002938-73-IT (EUCTR) | 01/12/2016 | 22/02/2018 | A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness. - NA | Myasthenia Gravis who have Generalized Muscle Weakness MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 Other descriptive name: ARGX-113 | ARGEN-X BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden | ||
| 105 | EUCTR2016-002938-73-ES (EUCTR) | 08/11/2016 | 26/09/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | Myasthenia Gravis who have Generalized Muscle Weakness MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;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 |
| 106 | EUCTR2016-002938-73-BE (EUCTR) | 31/10/2016 | 13/09/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness | Myasthenia Gravis who have Generalized Muscle Weakness MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Netherlands;Italy;Sweden | ||
| 107 | NCT02950155 (ClinicalTrials.gov) | October 16, 2016 | 28/10/2016 | A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis | A Randomized, Double-blind, Placebo-controlled Multicenter Study Evaluating the Safety and Efficacy of Rituximab (Mabthera®) in Patients With New Onset Generalized Myasthenia Gravis (MG) | Generalized Myasthenia Gravis | Drug: Rituximab;Drug: Sodium Chloride solution | Fredrik Piehl | NULL | Active, not recruiting | 18 Years | N/A | All | 47 | Phase 3 | Sweden |
| 108 | EUCTR2016-003138-26-NL (EUCTR) | 04/10/2016 | 08/08/2016 | Flu vaccine in patients with Myasthenia Gravis | Influenza vaccination in patients with Myasthenia Gravis - Influenza vaccine in Myasthenia Gravis | Myasthenia gravis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Influenza vaccine Product Name: Influenza vaccine | LUMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 109 | ChiCTR1800017696 | 2016-07-01 | 2018-08-10 | Effect of Magnesium Sulfate on Muscle Strength in Patients with Myasthenia Gravis | Effect of Magnesium Sulfate on Muscle Strength in Patients with Myasthenia Gravis | Myasthenia Gravis | Group A:Magnesium Sulfate;Group B:Normal saline; | The University of Hong Kong-Shenzhen Hospital | NULL | Recruiting | 18 | 60 | Both | Group A:30;Group B:30; | China | |
| 110 | EUCTR2015-005749-30-SE (EUCTR) | 23/06/2016 | 28/04/2016 | A clinical trial investigating the effect and safety of the drug rituximab in patients with new onset myasthenia gravis, an autoimmune condition affecting muscle strenght | A randomized, doubleblind, placebo-controlled multicenter trial to evaluate the safety and efficacy of rituximab (Mabthera) in subjects with new onset myasthenia gravis; the RINOMAX study - Rinomax | New onset myasthenia gravis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | 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 |
| 111 | EUCTR2014-003997-18-DE (EUCTR) | 30/05/2016 | 27/07/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;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: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | Lithuania;Germany;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;France;United States | ||
| 112 | NCT02609022 (ClinicalTrials.gov) | March 2016 | 13/11/2015 | Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis | A First-in-human and Proof-of-concept Study to Assess the Safety, Tolerability and Immunogenic Response of CV-MG01, Acetylcholine Receptor Mimetic Peptides, as Potential Therapeutic Vaccine, in Patients With Myasthenia Gravis | Myasthenia Gravis | Biological: CV-MG01;Biological: Placebo | CuraVac | Aepodia;University Hospital, Antwerp;Leiden University Medical Center | Completed | 18 Years | 64 Years | All | 24 | Phase 1;Phase 2 | Belgium |
| 113 | EUCTR2013-005098-28-LV (EUCTR) | 17/12/2015 | 22/10/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Grifols Therapeutics LLC | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Hungary;Estonia;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia | |||
| 114 | EUCTR2013-005099-17-DE (EUCTR) | 18/11/2015 | 28/07/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | |||
| 115 | 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 | |||
| 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 |
| 116 | EUCTR2013-005098-28-EE (EUCTR) | 07/10/2015 | 14/09/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Grifols Therapeutics LLC | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Hungary;Czech Republic;Estonia;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia | |||
| 117 | EUCTR2013-005099-17-BE (EUCTR) | 06/10/2015 | 15/01/2016 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 19.1;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: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 118 | EUCTR2014-003997-18-BE (EUCTR) | 06/10/2015 | 18/01/2016 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 18.1;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: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 119 | EUCTR2015-003127-62-IT (EUCTR) | 02/10/2015 | 17/03/2017 | A Randomized, Placebo-Controlled Study to Evaluate the Effect of Amifampridine in Patients with MuSK Antibody Positive Myasthenia Gravis | A Randomized, Placebo-Controlled, Pilot Crossover Study to Evaluate the Effect of Amifampridine Phosphate(3,4-Diaminopyridine Phosphate) in Patients with MuSK Antibody Positive Myasthenia Gravis - MuSK-001 | Patients with MuSK Antibody Positive Myasthenia Gravis MedDRA version: 19.1;Level: LLT;Classification code 10062976;Term: Neuromuscular weakness;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE Product Name: AMIFAMPRIDINA INN or Proposed INN: AMIFAMPRIDINA | FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Italy | ||
| 120 | 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 | |||
| 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 |
| 121 | NCT02565576 (ClinicalTrials.gov) | September 29, 2015 | 23/6/2015 | Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis | A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Preliminarily Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of CFZ533 in Patients With Moderate to Severe Myasthenia Gravis | Myasthenia Gravis, Generalized | Drug: Placebo;Drug: CFZ533 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 85 Years | All | 44 | Phase 2 | Canada;Denmark;Germany;Russian Federation;Taiwan |
| 122 | EUCTR2013-005099-17-CZ (EUCTR) | 10/09/2015 | 17/06/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Belgium;Poland;Lithuania;Germany | |||
| 123 | EUCTR2014-003997-18-CZ (EUCTR) | 10/09/2015 | 17/06/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;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: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 124 | EUCTR2015-000097-35-DK (EUCTR) | 03/09/2015 | 16/06/2015 | Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis | Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine. MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | Taiwan;Canada;Denmark;Russian Federation;Germany | |||
| 125 | EUCTR2015-000097-35-DE (EUCTR) | 02/09/2015 | 05/06/2015 | Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis | Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine. MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CFZ533 Other descriptive name: CFZ533 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | Taiwan;Canada;Denmark;Russian Federation;Germany | ||
| 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 |
| 126 | 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 | |||
| 127 | NCT02473952 (ClinicalTrials.gov) | August 2015 | 14/6/2015 | A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects With Generalized Myasthenia Gravis | Myasthenia Gravis, Generalized | Drug: IGIV-C;Drug: Placebo | Grifols Therapeutics LLC | NULL | Completed | 18 Years | 85 Years | All | 62 | Phase 2 | United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic |
| 128 | EUCTR2013-005098-28-RO (EUCTR) | 21/07/2015 | 10/03/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 18.1;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: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | France;Estonia;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Russian Federation;Germany | |||
| 129 | EUCTR2013-005099-17-HU (EUCTR) | 13/07/2015 | 26/05/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany | |||
| 130 | EUCTR2014-003997-18-HU (EUCTR) | 13/07/2015 | 26/05/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 18.1;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: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany | ||
| 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 |
| 131 | EUCTR2014-003997-18-LT (EUCTR) | 07/07/2015 | 25/05/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;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: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 132 | EUCTR2013-005098-28-PL (EUCTR) | 07/07/2015 | 01/06/2015 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 20.0;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: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Hungary;Estonia;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Russian Federation;South Africa;Latvia | ||
| 133 | EUCTR2013-005099-17-LT (EUCTR) | 07/07/2015 | 25/05/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;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: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | ||
| 134 | EUCTR2013-005099-17-EE (EUCTR) | 22/06/2015 | 26/05/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose. | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Grifols Therapeutics LLC | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany | |||
| 135 | EUCTR2014-003997-18-EE (EUCTR) | 22/06/2015 | 26/05/2015 | A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21). | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis | Myasthenia Gravis MedDRA version: 20.0;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: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany | ||
| 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 |
| 136 | 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 | |||
| 137 | NCT02473965 (ClinicalTrials.gov) | June 2015 | 14/6/2015 | Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of lGIV-C as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis | Myasthenia Gravis | Drug: IGIV-C;Drug: Placebo | Grifols Therapeutics LLC | NULL | Completed | 18 Years | 85 Years | All | 60 | Phase 2 | United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic |
| 138 | NCT02100969 (ClinicalTrials.gov) | May 2015 | 27/3/2014 | Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis | Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis | Myasthenia Gravis | Drug: HIZENTRA ® | Mazen Dimachkie, MD | CSL Behring | Completed | 18 Years | N/A | All | 23 | Phase 2 | United States;Canada |
| 139 | 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 | |||
| 140 | 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 | ||
| 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 |
| 141 | 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 | ||
| 142 | EUCTR2013-005098-28-BE (EUCTR) | 13/03/2015 | 12/12/2014 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 18.1;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: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Estonia;Russian Federation;Israel;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;South Africa;Latvia;Germany;Netherlands;Korea, Republic of | ||
| 143 | JPRN-UMIN000016564 | 2015/03/13 | 23/02/2015 | Rituximab for intractable myasthenia gravis | myasthenia gravis | rituximab | Tokushima University Hospital | NULL | Pending | 15years-old | 80years-old | Male and Female | 1 | Not selected | Japan | |
| 144 | NCT02413580 (ClinicalTrials.gov) | March 2015 | 7/4/2015 | A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations | A Multicenter, Prospective, Open-label, Non-controlled Clinical Trial to Assess the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Patients With Myasthenia Gravis Exacerbations | Myasthenia Gravis Exacerbations | Biological: IGIV-C | Grifols Therapeutics LLC | NULL | Completed | 18 Years | N/A | All | 49 | Phase 3 | Argentina;Belgium;Canada;Czechia;Estonia;France;Hungary;Latvia;Poland;Romania;Russian Federation;South Africa;Czech Republic |
| 145 | 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 |
| 146 | EUCTR2014-004344-35-NL (EUCTR) | 16/02/2015 | 16/02/2015 | The effect of tetanus revaccination in patients with myasthenia gravis | The effect of tetanus revaccination in patients with myasthenia gravis - Tetanus revaccination in patients with myasthenia gravis | Myasthenia gravisLambert-Eaton myasthenic syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tetanus vaccin Product Name: Tetanus vaccin | Leiden University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | Netherlands | ||
| 147 | EUCTR2013-005098-28-CZ (EUCTR) | 16/01/2015 | 03/10/2014 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 20.0;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: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics LLC. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Hungary;Estonia;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia | ||
| 148 | 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 | ||
| 149 | 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 | ||
| 150 | EUCTR2013-005098-28-HU (EUCTR) | 21/11/2014 | 07/10/2014 | A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. | A multicenter, prospective, open-label, non-controlled clinical trial to assess the efficacy and safety of Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in patients with Myasthenia Gravis exacerbations | Myasthenia Gravis Exacerbations MedDRA version: 19.0;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: GAMUNEX 10% INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Grifols Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 3 | Estonia;Russian Federation;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;South Africa;Netherlands;Latvia | ||
| 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 |
| 151 | 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 |
| 152 | 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 | ||
| 153 | 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 | |||
| 154 | 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 | ||
| 155 | NCT02102594 (ClinicalTrials.gov) | October 2014 | 25/3/2014 | Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) | Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) | Myasthenia Gravis;Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: Bortezomib | Charite University, Berlin, Germany | Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology);NeuroCure Clinical Research Center, Charite, Berlin | Terminated | 18 Years | 75 Years | All | 11 | Phase 2 | Germany |
| 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 |
| 156 | NCT02774239 (ClinicalTrials.gov) | October 2014 | 20/4/2015 | A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG) | A Pilot Trial To Assess The Feasibility And Efficacy Of Subcutaneous Immunoglobulin In Patients With Myasthenia Gravis Exacerbation | Myasthenia Gravis | Drug: Human normal immunoglobulin G (IgG) | University of Alberta | CSL Behring | Recruiting | 18 Years | 80 Years | All | 30 | Phase 3 | Canada |
| 157 | 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 | ||
| 158 | JPRN-UMIN000015019 | 2014/09/02 | 02/09/2014 | Initial therapy for myasthenia gravis of combined therapy for tacrolimus and IVIG | Myasthenia gravis | Tacrolimus and IVIG | Kansai medical university | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 20 | Not applicable | Japan | |
| 159 | EUCTR2014-001355-23-NL (EUCTR) | 29/08/2014 | 14/05/2014 | Ephedrine as add-on therapy for patients with myasthenia gravis | Ephedrine as add-on therapy for patients with myasthenia gravis - Ephedrine for MG | myasthenia gravis MedDRA version: 17.0;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: Hidrocloruro de efedrina INN or Proposed INN: EPHEDRINE HYDROCHLORIDE Other descriptive name: EPHEDRINE HYDROCHLORIDE | Leiden University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 160 | ChiCTR-IPR-15006081 | 2014-07-18 | 2015-03-14 | A prospective study of combined use of prednisone and methotrexate for the treatment of myasthenia gravis | A prospective study of combined use of prednisone and methotrexate for the treatment of myasthenia gravis | myasthenia gravis | prednisone group:prednisone;Prednisone + methotrexate:Prednisone + methotrexate; | Xuan Wu Hospital, Capital Medical University | NULL | Recruiting | 18 | 80 | Both | prednisone group:15;Prednisone + methotrexate:15; | Phase 4 | NULL |
| 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 |
| 161 | EUCTR2013-005362-19-DE (EUCTR) | 17/07/2014 | 18/12/2013 | Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB) | Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB) - TAVAB | Myasthenia Gravis Systemic Lupus Erythematosus Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Charité - Universitätsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Germany | |||
| 162 | 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 | ||
| 163 | 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 | ||
| 164 | 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 | |||
| 165 | NCT02110706 (ClinicalTrials.gov) | May 2014 | 7/4/2014 | BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis | B Cell Targeted Treatment In Myasthenia Gravis (BeatMG): A Phase II Trial of Rituximab In Myasthenia Gravis | Myasthenia Gravis | Drug: Rituximab;Drug: Placebo | Yale University | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 21 Years | 90 Years | All | 52 | Phase 2 | United States |
| 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 |
| 166 | ChiCTR-OCC-14004533 | 2014-04-30 | 2014-04-16 | The superior anesthetic management scheme during perioperative period for myasthenia gravis patients | The superior anesthetic management scheme during perioperative period for myasthenia gravis patients | myasthenia gravis | volunteer:muscle relaxant monitor;MG group:muscle relaxant monitor; | Yijishan Hospital, Wannan Medical College, Wuhu 241001, China | NULL | Completed | 10 | 66 | Both | volunteer:30;MG group:30; | China | |
| 167 | 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 | |||
| 168 | 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 | ||
| 169 | 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 | ||
| 170 | 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 | ||
| 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 |
| 171 | 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 | ||
| 172 | 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 | ||
| 173 | 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 | |||
| 174 | 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 |
| 175 | JPRN-UMIN000012089 | 2013/10/15 | 23/10/2013 | Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study | Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study - Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study | MuSK antibody-positive myasthenia gravis | Administration of Rituximab at the standard dose of 375 mg/m2 every week for 4 consecutive weeks and then monthly for the next 3 months. | Department of NeurologyUniversity of Tokyo, Graduate School of Medicine | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 5 | Not selected | Japan |
| 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 |
| 176 | NCT01480596 (ClinicalTrials.gov) | April 2013 | 27/10/2011 | The Evaluation of Belimumab in Myasthenia Gravis (MG) | A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects With Generalized Myasthenia Gravis (MG) | Myasthaenia Gravis | Biological: Belimumab;Other: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 40 | Phase 2 | United States;Canada;Germany;Italy |
| 177 | ChiCTR-OCC-13003090 | 2012-12-20 | 2013-03-02 | Research on micrornas expression of Myasthenia gravis and the relationship with TH1, TH2 cells secrete cytokines | Research on micrornas expression of Myasthenia gravis and the relationship with TH1, TH2 cells secrete cytokines | Myasthenia gravis | experimental group:Pyridostigmine Bromide;control group:nothing; | The first affiliated hospital of Guangzhou university of Traditional Chinese medicine | NULL | Completed | 18 | 65 | Both | experimental group:30;control group:30; | China | |
| 178 | EUCTR2012-001544-21-ES (EUCTR) | 07/11/2012 | 23/08/2012 | Intravenous immunoglobulin for preparing myasthenia gravis patients for thymectomy and other surgical procedures preventing myasthenic crisis. | Intravenous immunoglobulin for preparing myasthenia gravis patients for thymectomy and other surgical procedures preventing myasthenic crisis. | Myasthenia gravis MedDRA version: 15.0;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: PRIVIGEN Other descriptive name: IMMUNOGLOBULIN G | Vall d'Hebron Institut de Recerca (VHIR) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Spain | |||
| 179 | NCT01727193 (ClinicalTrials.gov) | September 2012 | 8/11/2012 | The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy | Myasthenia Gravis | Drug: Azathioprine;Drug: Leflunomide | First Affiliated Hospital, Sun Yat-Sen University | NULL | Recruiting | 12 Years | 65 Years | All | 158 | Phase 3 | China | |
| 180 | JPRN-UMIN000007679 | 2012/04/01 | 09/04/2012 | Randomized comparative study on efficacy and safety of tacrolimus, prednisolone or placebo in ocular myasthenia gravis patients | Myasthenia gravis | Administration of tacrolimus 3 mg/day Administration of prednisolone 5 mg/day anticholinesterases | Department of Neurology, Chiba University Graduate School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan | |
| 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 |
| 181 | JPRN-UMIN000007671 | 2012/04/01 | 09/04/2012 | Randomized comparative study on efficacy and safety of reduced-dose steroid combined with tacrolimus vs conventional-dose steroid in late- or elderly-onset myasthenia gravis patients | Myasthenia gravis | Administration of prednisolone 35 mg/day with tacrolimus 3mg a day Administration of prednisolone 50 mg/day | Department of Neurology, Chiba University Graduate School of Medicine | NULL | Recruiting | 50years-old | Not applicable | Male and Female | 40 | Not applicable | Japan | |
| 182 | NCT01555580 (ClinicalTrials.gov) | April 2012 | 13/3/2012 | A Pilot Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Generalized Myasthenia Gravis | A Pilot Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Symptomatic Autoimmune Generalized Myasthenia Gravis | Myasthenia Gravis | Drug: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) | Muscular Dystrophy Association | NULL | Not yet recruiting | 18 Years | 80 Years | Both | 12 | Phase 0 | United States |
| 183 | EUCTR2011-002068-26-IT (EUCTR) | 28/12/2011 | 15/12/2011 | A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG) | A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG) - Evaluate the Use of Belimumab in Myasthenia Gravis (MG) | Subjects with Generalized Myasthenia Gravis (MG) MedDRA version: 14.0;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: BENLYSTA® (belimumab) INN or Proposed INN: BELIMUMAB | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 42 | United States;Canada;Germany;Italy | |||
| 184 | NCT00995722 (ClinicalTrials.gov) | December 2011 | 14/10/2009 | Efficacy of Prednisone In the Treatment of Ocular Myasthenia | Efficacy of Prednisone In the Treatment of Ocular Myasthenia: The EPITOME' Study | Ocular Myasthenia Gravis | Drug: Prednisone;Drug: Placebo | Michael Benatar | University of Miami;University of Rochester | Terminated | 18 Years | N/A | All | 11 | Phase 3 | United States;Canada |
| 185 | NCT02012933 (ClinicalTrials.gov) | December 2011 | 11/12/2013 | 3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenia (CM) | 3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenia | Lambert-Eaton Myasthenic Syndrome (LEMS);Congenital Myasthenia (CM) | Drug: 3,4-diaminopyridine | Oregon Health and Science University | Jacobus Pharmaceutical | No longer available | 2 Years | N/A | All | United States | ||
| 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 |
| 186 | EUCTR2011-002068-26-DE (EUCTR) | 24/11/2011 | 05/10/2011 | A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG) | A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG). | Myasthenia Gravis MedDRA version: 17.0;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: BENLYSTA® (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 42 | United States;Canada;Germany;Italy | |||
| 187 | EUCTR2010-021850-20-IT (EUCTR) | 23/11/2011 | 07/03/2012 | A Phase 3 placebo controlled study to evaluate safety and efficacy of Amifampridine phosphate. | A Phase 3, Multicenter, Double-blind, Placebo-controlled Randomized Discontinuation Study Followed by an Open-label Extension Period to Evaluate the Efficacy and Safety of Amifampridine Phosphate (3,4-Diaminopyridine Phosphate) in Patients with Lambert-Eaton Myasthenic Syndrome (LEMS) | Lambert-Eaton Myasthenic Syndrome (LEMS) MedDRA version: 14.1;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: FIRDAPSE 10mg Tablets INN or Proposed INN: AMIFAMPRIDINE Other descriptive name: 3,4-DAP | BIOMARIN PHARMACEUTICAL INC. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Hungary;Spain;Bulgaria;Germany;Italy | ||
| 188 | NCT01828294 (ClinicalTrials.gov) | October 2011 | 1/11/2011 | Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis | Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis | Myasthenia Gravis | Drug: Subcutaneous immunoglobulins | St. Louis University | CSL Behring | Terminated | 18 Years | 80 Years | All | 4 | Phase 1 | United States |
| 189 | NCT01325571 (ClinicalTrials.gov) | March 2011 | 16/3/2011 | A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis | A Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid Therapy | Myasthenia Gravis | Drug: Tacrolimus capsule;Drug: Placebo | Astellas Pharma Inc | Astellas Pharma China, Inc. | Completed | 18 Years | 70 Years | Both | 83 | Phase 3 | China |
| 190 | NCT01268280 (ClinicalTrials.gov) | December 2010 | 28/12/2010 | Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis | A Phase II, Double-Blind, Randomized, Three-Way Crossover, Placebo-Controlled, Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis on Standard Therapy | Myasthenia Gravis | Drug: Placebo;Drug: 250 mg CK-2017357;Drug: 500 mg CK-2017357 | Cytokinetics | National Institute of Neurological Disorders and Stroke (NINDS) | Terminated | 18 Years | 80 Years | All | 32 | Phase 2 | United States |
| 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 |
| 191 | ChiCTR-TRC-13004125 | 2010-10-01 | 2013-06-08 | The study on the pathogenesis of spleen-kidney deficiency type myasthenia gravis and the interference effect of Jianji Ning Granule on the patients | The study on the pathogenesis of spleen-kidney deficiency type myasthenia gravis and the interference effect of Jianji Ning Granule on the patients | Myasthenia gravis | trial:Jianji Ning Granule combined with olfactory pyridostigmine tablets ;Control:olfactory pyridostigmine tablets ; | Longhua Hospital Affiliated to Shanghai University of traditional Chinese Medicine | NULL | Completed | 14 | 75 | Both | trial:30;Control:30; | I+2 (Phase 1;Phase 2) | China |
| 192 | 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 | |||
| 193 | NCT00987116 (ClinicalTrials.gov) | June 2009 | 29/9/2009 | Study Comparing Two Tapering Strategies of Prednisone in Myasthenia Gravis | Comparison of Two Tapering Strategies of Prednisone in Patients With Generalised Myasthenia Gravis Treated With Prednisone and Azathioprine: a Single-blind Randomised Controlled Multicenter Study | Myasthenia Gravis | Drug: Prednisone - Azathioprine | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | 80 Years | All | 118 | Phase 4 | France |
| 194 | NCT00997412 (ClinicalTrials.gov) | May 2009 | 16/10/2009 | Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis | Randomized, Double-blind, Double-dummy Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis | Myasthenia Gravis | Drug: Mycophenolic acid;Drug: AZA | Qualitix Clinical Research Co., Ltd. | NULL | Active, not recruiting | 20 Years | 70 Years | Both | 40 | N/A | NULL |
| 195 | NCT00814138 (ClinicalTrials.gov) | April 2009 | 23/12/2008 | Efficacy of Methotrexate in Myasthenia Gravis | Phase II Trial of Methotrexate in Myasthenia Gravis | Myasthenia Gravis | Drug: Methotrexate;Other: Placebo | University of Kansas Medical Center | NULL | Completed | 18 Years | N/A | All | 50 | Phase 2 | United States;Canada |
| 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 |
| 196 | EUCTR2007-001377-28-PT (EUCTR) | 09/01/2009 | 25/08/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 197 | 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 |
| 198 | EUCTR2007-001377-28-DE (EUCTR) | 01/09/2008 | 15/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 199 | EUCTR2007-002817-37-IT (EUCTR) | 29/07/2008 | 30/06/2008 | A PHASE II, PLACEBO CONTROLLED, DOSE FINDING PILOT STUDY OF PIXANTRONE EFFICACY ADMINISTERED INTRAVENOUSLY IN PATIENTS AFFECTED WITH MYASTHENIA GRAVIS - ND | A PHASE II, PLACEBO CONTROLLED, DOSE FINDING PILOT STUDY OF PIXANTRONE EFFICACY ADMINISTERED INTRAVENOUSLY IN PATIENTS AFFECTED WITH MYASTHENIA GRAVIS - ND | Patients affected with MG showing clinically meaningful improvement after therapeutic plasmapheresis. MedDRA version: 9.1;Level: LLT;Classification code 10028417;Term: Myasthenia gravis | Product Name: PIXANTRONE Product Code: BBR 2778 INN or Proposed INN: pixantrone | ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Italy | |||
| 200 | EUCTR2007-001377-28-NL (EUCTR) | 15/07/2008 | 29/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 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 |
| 201 | EUCTR2007-001377-28-AT (EUCTR) | 26/06/2008 | 27/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 202 | EUCTR2007-001377-28-FR (EUCTR) | 11/06/2008 | 29/02/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 203 | NCT00716066 (ClinicalTrials.gov) | June 2008 | 15/7/2008 | 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;Autoimmune Nervous System Disorder;Central Nervous System Vasculitis;Cerebellar Degeneration;Chronic Inflammatory Demyelinating Polyneuropathy;Lambert Eaton Myasthenic Syndrome;Myasthenia Gravis;Neuromyelitis Optica;Opsoclonus Myoclonus Syndrome;Rasmussen Subacute Encephalitis | 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 | 71 Years | All | 40 | Phase 2 | United States |
| 204 | NCT00774462 (ClinicalTrials.gov) | January 2008 | 16/10/2008 | Rituximab for the Treatment of Refractory Inflammatory Myopathies and Refractory Myasthenia Gravis | FORCE: Rituximab (CD 20+-B Cell-depleting Monoclonal Antibody) for the Treatment of Refractory Inflammatory Myopathies With Specific Antibodies and Refractory Myasthenia Gravis | Myositis;Myasthenia Gravis | Drug: Rituximab | Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France;Roche Pharma AG | Completed | 18 Years | 80 Years | Both | 30 | Phase 2 | France |
| 205 | NCT00541216 (ClinicalTrials.gov) | October 2007 | 7/10/2007 | Ephedrine for the Treatment of Congenital Myasthenia | Myasthenic Syndromes, Congenital | Drug: Ephedrine | Hadassah Medical Organization | NULL | Enrolling by invitation | 12 Years | 75 Years | Both | 15 | Phase 1;Phase 2 | Israel | |
| 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 |
| 206 | NCT00515450 (ClinicalTrials.gov) | July 2007 | 10/8/2007 | Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis | A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Biological: GB-0998 (Intravenous immunoglobulin);Procedure: Plasmapheresis | Benesis Corporation | NULL | Completed | 16 Years | N/A | Both | 46 | Phase 3 | Japan |
| 207 | NCT01179893 (ClinicalTrials.gov) | March 2007 | 9/8/2010 | Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis | A Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia Gravis | Myasthenia Gravid | Biological: IVIG;Procedure: PLEX | University Health Network, Toronto | Grifols Therapeutics Inc. | Completed | 18 Years | N/A | Both | 87 | Phase 4 | Canada |
| 208 | EUCTR2006-004374-27-DE (EUCTR) | 12/10/2006 | 07/09/2006 | Prospective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIent | Prospective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIent | Generalized Myasthenia gravis with positive antibodies against Acetylcholine-receptors (ICD10GM2006 G70.0) | Trade Name: Mutagrip Product Name: Mutagrip | Philipps-University | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 209 | NCT00294658 (ClinicalTrials.gov) | June 2006 | 21/2/2006 | Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy | A Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving Prednisone | Myasthenia Gravis | Procedure: thymectomy plus prednisone;Drug: prednisone alone | University of Alabama at Birmingham | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | 65 Years | All | 126 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;Chile;Germany;Italy;Japan;Mexico;Netherlands;Poland;Portugal;South Africa;Spain;Taiwan;Thailand;United Kingdom;Ireland |
| 210 | NCT00309088 (ClinicalTrials.gov) | April 2006 | 29/3/2006 | FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients | FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients | Myasthenia Gravis | Drug: tacrolimus;Drug: placebo | Astellas Pharma Inc | NULL | Completed | 16 Years | 64 Years | Both | 80 | Phase 3 | Japan |
| 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 |
| 211 | EUCTR2005-000343-28-IT (EUCTR) | 29/03/2006 | 15/03/2006 | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis - ND | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis - ND | Myasthenia Gravis MedDRA version: 6.1;Level: PT;Classification code 10028417 | Trade Name: cellcept INN or Proposed INN: Mycophenolic acid | ASPREVA PHARMACEUTICALS CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 136 | United Kingdom;Germany;Spain;Italy | |||
| 212 | EUCTR2005-002740-26-GB (EUCTR) | 21/02/2006 | 01/12/2005 | A Phase II Double Blind, Cross-Over Study to Compare the Safety and Efficacy of 10, 20 and 40 mg Monarsen (EN101) administered to Patients with Myasthenia Gravis | A Phase II Double Blind, Cross-Over Study to Compare the Safety and Efficacy of 10, 20 and 40 mg Monarsen (EN101) administered to Patients with Myasthenia Gravis | Myasthenia Gravis MedDRA version: 8.1;Level: LLT;Classification code 10028417;Term: Myasthenia gravis | Ester Neuroscience Ltd | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | United Kingdom | |||
| 213 | NCT00309101 (ClinicalTrials.gov) | February 2006 | 29/3/2006 | An Open Study for Steroid Resistant, Non-Thymectomized MG Patients | FK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG Patients | Myasthenia Gravis | Drug: tacrolimus | Astellas Pharma Inc | NULL | Completed | 16 Years | 64 Years | Both | 11 | Phase 3 | Japan |
| 214 | EUCTR2005-000343-28-DE (EUCTR) | 19/12/2005 | 10/05/2005 | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) | Myasthenia Gravis MedDRA version: 8.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis | Trade Name: Cellcept 500 mg tablets Product Name: CellCept 500 mg tablets INN or Proposed INN: mycophenolate mofetil | Aspreva Pharmaceuticals Corporation | NULL | Not Recruiting | Female: yes Male: yes | 136 | Spain;Germany;Italy;United Kingdom | |||
| 215 | EUCTR2004-000596-34-HU (EUCTR) | 30/09/2005 | 08/06/2005 | A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. | A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. | Myasthenia gravis MedDRA version: 7;Level: PT;Classification code 10028417 | Trade Name: CellCept®500 mg tablets Product Name: CellCept 500 mg film-coated tablets INN or Proposed INN: mycophenolate mofetil | F. Hoffmann-La Roche Ltd as part of the Aspreva Rare Disease Program | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;Spain;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 |
| 216 | EUCTR2005-000343-28-GB (EUCTR) | 05/09/2005 | 28/06/2005 | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) | Myasthenia Gravis MedDRA version: 7;Level: PT;Classification code 10028417 | Product Name: CellCept 500 mg tablets INN or Proposed INN: mycophenolate mofetil | Aspreva Pharmaceutical Corporation | NULL | Not Recruiting | Female: yes Male: yes | 136 | Germany;United Kingdom;Spain;Italy | |||
| 217 | EUCTR2004-000596-34-ES (EUCTR) | 01/09/2005 | 05/07/2005 | A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. | A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. | Myasthenia gravis MedDRA version: 7;Level: PT;Classification code 10028417 | Trade Name: CellCept®500 mg tablets Product Name: CellCept 500 mg film-coated tablets INN or Proposed INN: mycophenolate mofetil | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Hungary;Czech Republic;Spain;Italy | |||
| 218 | EUCTR2004-000596-34-IT (EUCTR) | 01/06/2005 | 20/06/2005 | A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis (MG) | A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis (MG) | Myastenia gravis MedDRA version: 6.1;Level: PT;Classification code 10028417 | Trade Name: CELLCEPT INN or Proposed INN: Mycophenolic acid | ASPREVA PHARMACEUTICALS CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;Spain;Italy | |||
| 219 | EUCTR2004-000596-34-CZ (EUCTR) | 19/05/2005 | 06/05/2005 | A prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravis | A prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravis | Myasthenia gravis MedDRA version: 7.1;Level: LLT;Classification code 10028417 | Trade Name: CellCept 500 mg Product Name: CellCept | F.Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;Spain;Italy | |||
| 220 | NCT00683969 (ClinicalTrials.gov) | August 2004 | 19/5/2008 | A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia Gravis | Myasthenia Gravis, Generalized | Drug: mycophenolate mofetil (CellCept);Drug: placebo | Hoffmann-La Roche | Aspreva Pharmaceuticals | Completed | 18 Years | 80 Years | Both | 136 | Phase 3 | United States;Canada;Former Serbia and Montenegro;France;Germany;India;Israel;Italy;Mexico;Netherlands;Russian Federation;Spain;Ukraine;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 |
| 221 | NCT00408213 (ClinicalTrials.gov) | June 2004 | 5/12/2006 | A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis. | A Randomized, Double-Blind Study to Evaluate the Safety of Continued Treatment With CellCept in Patients With Well-Controlled Myasthenia Gravis Receiving a Stable Dose of Prednisone | Myasthenia Gravis Generalised | Drug: mycophenolate mofetil [CellCept];Drug: Placebo | Hoffmann-La Roche | Aspreva Pharmaceuticals | Completed | 18 Years | 80 Years | Both | 136 | Phase 3 | United States;Former Serbia and Montenegro;France;Germany;Italy;Ukraine;United Kingdom;Israel;Spain;Canada;Czech Republic;Mexico;Netherlands |
| 222 | NCT00619671 (ClinicalTrials.gov) | April 2004 | 14/1/2008 | A Pilot Trial of Rituxan in Refractory Myasthenia Gravis | Phase 1-2 Pilot Study of Rituximab (Rituxan) in Refractory Myasthenia Gravis. | Refractory Myasthenia Gravis | Drug: Rituximab (Rituxan) | University of Vermont | Genentech, Inc. | Completed | 18 Years | 80 Years | Both | 10 | Phase 1;Phase 2 | United States |
| 223 | NCT00306033 (ClinicalTrials.gov) | March 2004 | 21/3/2006 | Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis | IVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical Trial | Myasthenia Gravis | Drug: Intravenous ImmuneGlobulin | University Health Network, Toronto | NULL | Completed | 18 Years | N/A | Both | 50 | Phase 3 | Canada |
| 224 | NCT00285350 (ClinicalTrials.gov) | September 2002 | 31/1/2006 | Mycophenolate Mofetil in Myasthenia Gravis | A Trial of Mycophenolate Mofetil in Myasthenia Gravis | Myasthenia Gravis | Drug: mycophenolate mofetil | FDA Office of Orphan Products Development | Duke University | Completed | 18 Years | N/A | Both | 80 | Phase 3 | NULL |
| 225 | NCT00424489 (ClinicalTrials.gov) | February 2002 | 18/1/2007 | Hematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia Gravis | Hematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia Gravis | Myasthenia Gravis | Biological: Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Drug: ATG (rabbit);Drug: Mesna;Drug: Methylprednisolone;Drug: G-CSF | Northwestern University | NULL | Terminated | 15 Years | 65 Years | All | 9 | Phase 1 | United States |
| 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 |
| 226 | NCT00004682 (ClinicalTrials.gov) | March 1995 | 24/2/2000 | Randomized Study of Intravenous Immunoglobulin in Patients With Mild or Moderate Myasthenia Gravis | Myasthenia Gravis | Drug: immune globulin | University of Texas | NULL | Terminated | 15 Years | N/A | Both | 100 | N/A | NULL |