11. 重症筋無力症 ［臨床試験数：96，薬物数：101（DrugBank：36），標的遺伝子数：33，標的パスウェイ数：80］
Searched query = "Myasthenia gravis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04146051 | November 1, 2019 | 11 November 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 | Recruiting | 18 Years | N/A | All | 18 | Phase 1/Phase 2 | United States | |
| 2 | NCT04115293 | October 1, 2019 | 22 October 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 | Recruiting | 18 Years | 75 Years | All | 130 | Phase 3 | United States | |
| 3 | NCT04124965 | October 2019 | 28 October 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 | Myasthenia Gravis | Drug: Rozanolixizumab | UCB Biopharma S.P.R.L. | Not recruiting | 18 Years | N/A | All | 240 | Phase 3 | ||
| 4 | NCT03896295 | August 6, 2019 | 11 November 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. | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom | |
| 5 | NCT03971422 | June 3, 2019 | 11 November 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 | Myasthenia Gravis | Drug: Rozanolixizumab;Other: Placebo | UCB Biopharma S.P.R.L. | Recruiting | 18 Years | N/A | All | 240 | Phase 3 | United States;Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03863080 | May 21, 2019 | 11 November 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 | Recruiting | 18 Years | N/A | All | 21 | Phase 2 | United States;Canada | |
| 7 | NCT03914638 | April 2019 | 29 April 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 | Recruiting | 18 Years | N/A | All | 50 | Phase 2/Phase 3 | Denmark | |
| 8 | NCT03920293 | March 26, 2019 | 4 November 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 | Recruiting | 18 Years | N/A | All | 160 | Phase 3 | United States;Canada;Italy;Japan;Korea, Republic of;Spain;Switzerland | |
| 9 | NCT03770403 | March 1, 2019 | 22 October 2019 | 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 BVBA | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | United States;Belgium;Czechia;Denmark;Italy;Japan;Poland | |
| 10 | NCT03759366 | December 21, 2018 | 2 September 2019 | 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 | Recruiting | 6 Years | 17 Years | All | 12 | Phase 3 | United States;Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | ChiCTR1800017564 | 2018-09-08 | 20 August 2018 | 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 | Not Recruiting | 1 | 80 | Both | Experiment group versus Control group:822; | Other | China | |
| 12 | NCT03669588 | September 5, 2018 | 14 October 2019 | 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 BVBA | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Serbia;United Kingdom | |
| 13 | NCT03579966 | July 1, 2018 | 26 August 2019 | 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. | Recruiting | 18 Years | N/A | All | 70 | Phase 3 | United States | |
| 14 | NCT03165435 | July 2018 | 11 June 2018 | 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 | Not recruiting | 18 Years | N/A | All | 0 | Phase 2/Phase 3 | Belgium;Netherlands |
| 15 | NCT03490539 | May 7, 2018 | 8 April 2019 | 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 | N/A | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT03510546 | April 9, 2018 | 11 June 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 |
| 17 | NCT03304054 | March 7, 2018 | 26 August 2019 | 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. | Recruiting | 18 Years | N/A | All | 60 | Phase 3 | United States | |
| 18 | ChiCTR1900024692 | 2018-01-01 | 29 July 2019 | 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 | 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 | |
| 19 | EUCTR2017-002599-15-DK | 07/11/2017 | 8 January 2018 | 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 Pharmaceutical Form: Capsule INN or Proposed INN: pyridostigmine CAS Number: 155-97-5 Other descriptive name: PYRIDOSTIGMINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Aarhus University | Authorised | Female: yes Male: yes | 32 | Phase 4 | Denmark | |||
| 20 | NCT03315130 | October 11, 2017 | 1 July 2019 | 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 | Not recruiting | 18 Years | 85 Years | All | 44 | Phase 2 | United States;Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2017-000323-27-BE | 19/06/2017 | 21 May 2018 | 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 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Not applicable Current Sponsor code: RhCA611-001-CRM197 Other descriptive name: T-peptide-CRM197 conjugate Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- INN or Proposed INN: Not applicable Current Sponsor code: RhCA67-16-CRM197 Other descriptive name: B-peptide-CRM197 conjugate Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Subcutaneous use | CuraVac Europe SA | Not Recruiting | Female: yes Male: yes | 66 | Phase 2;Phase 3 | Belgium;Netherlands | |||
| 22 | NCT03052751 | May 15, 2017 | 11 June 2019 | 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 | Other: Placebo;Drug: UCB7665 | UCB Biopharma S.P.R.L. | Not recruiting | 18 Years | N/A | All | 43 | Phase 2 | United States;Spain;Germany;Denmark;Czechia;Canada;Belgium | |
| 23 | NCT03059888 | April 12, 2017 | 25 February 2019 | 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 | Recruiting | 16 Years | 85 Years | All | 20 | Early Phase 1 | United States |
| 24 | EUCTR2016-002698-36-DE | 09/02/2017 | 18 June 2018 | 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 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: rozanolixizumab CAS Number: 1584645-37-3 Current Sponsor code: UCB7665 Other descriptive name: UCB7665 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Subcutaneous use | UCB Biopharma SPRL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany | |||
| 25 | NCT04101578 | February 8, 2017 | 7 October 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. | Recruiting | 15 Years | N/A | All | 2000 | N/A | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT02965573 | December 30, 2016 | 5 November 2018 | 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 BVBA | Quintiles, Inc. | Not recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States;Belgium;Canada;Italy;Netherlands;Poland;Spain;Sweden |
| 27 | EUCTR2016-002938-73-BE | 31/10/2016 | 11 December 2017 | 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: N/A CAS Number: 1821402-21-4 Current Sponsor code: ARGX-113 Other descriptive name: ARGX-113 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | Argenx BVBA | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Netherlands;Italy;Sweden | |||
| 28 | NCT02950155 | October 16, 2016 | 29 April 2019 | 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 | Recruiting | 18 Years | N/A | All | 44 | Phase 3 | Sweden | |
| 29 | EUCTR2016-003138-26-NL | 04/10/2016 | 24 October 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 Pharmaceutical Form: Suspension for injection Pharmaceutical form of the placebo: Suspension for injection Route of administration of the placebo: Intramuscular use | LUMC | Authorised | Female: yes Male: yes | Phase 4 | Netherlands | ||||
| 30 | ChiCTR1800017696 | 2016-07-01 | 20 August 2018 | 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 | Recruiting | 18 | 60 | Both | Group A:30;Group B:30; | New Treatment Measure Clinical Study | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2015-005749-30-SE | 23/06/2016 | 6 November 2018 | 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use | Karolinska Institutet | Authorised | Female: yes Male: yes | 60 | Phase 3 | Sweden | |||
| 32 | NCT02609022 | March 2016 | 11 February 2019 | 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 | Not recruiting | 18 Years | 64 Years | All | 24 | Phase 1/Phase 2 | Belgium |
| 33 | EUCTR2016-001384-37-DE | 28 February 2019 | 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: 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: Soliris Product Name: Soliris Product Code: Soliris Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ECULIZUMAB CAS Number: 219685-50-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Alexion Pharmaceuticals, Inc. | Not Available | Female: yes Male: yes | 17 | Phase 3 | United States;Germany;Japan | ||||
| 34 | EUCTR2015-003127-62-IT | 02/10/2015 | 3 April 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 Pharmaceutical Form: Tablet INN or Proposed INN: AMIFAMPRIDINA Current Sponsor code: 0 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 10-80 | FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA | Authorised | Female: yes Male: yes | 20 | Phase 2 | Italy | |||
| 35 | NCT02565576 | September 29, 2015 | 29 July 2019 | 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 | Not recruiting | 18 Years | 85 Years | All | 44 | Phase 2 | Canada;Denmark;Germany;Russian Federation;Taiwan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2015-000097-35-DE | 02/09/2015 | 28 August 2017 | 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 Pharmaceutical Form: Powder for solution for injection/infusion Other descriptive name: CFZ533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Intravenous use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | Taiwan;Canada;Denmark;Russian Federation;Germany | |||
| 37 | NCT02473952 | August 2015 | 18 March 2019 | 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 | Not recruiting | 18 Years | 85 Years | All | 62 | Phase 2 | United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic | |
| 38 | EUCTR2013-005099-17-LT | 07/07/2015 | 30 April 2019 | 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% Pharmaceutical Form: Solution for infusion INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Concentration unit: g/ml gram(s)/millilitre Concentration type: equal Concentration number: 0.10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Grifols Therapeutics Inc. | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | |||
| 39 | EUCTR2014-003997-18-LT | 07/07/2015 | 30 April 2018 | 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% Pharmaceutical Form: Solution for infusion INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Concentration unit: g/ml gram(s)/millilitre Concentration type: equal Concentration number: 0.10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Grifols Therapeutics Inc. | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany | |||
| 40 | NCT02473965 | June 2015 | 13 May 2019 | 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 | Not recruiting | 18 Years | 85 Years | All | 60 | Phase 2 | United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT02100969 | May 2015 | 11 June 2018 | 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 | Not recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States;Canada |
| 42 | JPRN-UMIN000016564 | 2015/03/13 | 2 April 2019 | Rituximab for intractable myasthenia gravis | myasthenia gravis | rituximab | Tokushima University Hospital | Not Recruiting | 15years-old | 80years-old | Male and Female | 1 | Not selected | Japan | ||
| 43 | ChiCTR-IPR-15006081 | 2015-03-02 | 18 April 2017 | A prospective study of combined use of small doses of hormones and methotrexate for the treatment of myasthenia gravis | A prospective study of combined use of small doses of hormones and methotrexate for the treatment of myasthenia gravis | myasthenia gravis | prednisone group:prednisone;Prednisone + methotrexate:Prednisone + methotrexate; | Xuan Wu Hospital, Capital Medical University | Recruiting | 18 | 80 | Both | prednisone group:15;Prednisone + methotrexate:15; | Post-market | ||
| 44 | NCT02413580 | March 2015 | 9 October 2018 | 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 | Not recruiting | 18 Years | N/A | All | 49 | Phase 3 | Latvia;Argentina;Belgium;Canada;Czechia;Estonia;France;Hungary;Poland;Romania;Russian Federation;South Africa;Czech Republic | |
| 45 | EUCTR2014-004344-35-NL | 16/02/2015 | 23 February 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 gravis Lambert-Eaton myasthenic syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tetanus vaccin Product Name: Tetanus vaccin Pharmaceutical Form: Solution for injection | Leiden University Medical Center | Authorised | Female: yes Male: yes | Netherlands | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | EUCTR2013-005098-28-CZ | 16/01/2015 | 23 July 2018 | 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% Pharmaceutical Form: Solution for infusion INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Concentration unit: g/ml gram(s)/millilitre Concentration type: equal Concentration number: 10g/100ml- | Grifols Therapeutics LLC. | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Hungary;Estonia;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia | |||
| 47 | EUCTR2013-002191-41-GB | 27/10/2014 | 23 January 2017 | 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ECULIZUMAB CAS Number: 219685-50-4 Current Sponsor code: h5G1.1-mAb Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | Alexion Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Spain;Ireland;Russian Federation;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden | |||
| 48 | EUCTR2013-002191-41-BE | 17/10/2014 | 28 February 2019 | 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] | Trade Name: SOLIRIS Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ECULIZUMAB CAS Number: 219685-50-4 Current Sponsor code: h5G1.1-mAb Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | Alexion Pharmaceuticals, Inc. | 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 | |||
| 49 | NCT02102594 | October 2014 | 10 December 2018 | 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 | Recruiting | 18 Years | 75 Years | All | 18 | Phase 2 | Germany |
| 50 | NCT02774239 | October 2014 | 16 December 2017 | 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 |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | JPRN-UMIN000015019 | 2014/09/02 | 2 April 2019 | Initial therapy for myasthenia gravis of combined therapy for tacrolimus and IVIG | Myasthenia gravis | Tacrolimus and IVIG | Kansai medical university | Recruiting | Not applicable | Not applicable | Male and Female | 20 | Not applicable | Japan | ||
| 52 | EUCTR2014-001355-23-NL | 29/08/2014 | 7 October 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 Pharmaceutical Form: Tablet INN or Proposed INN: EPHEDRINE HYDROCHLORIDE CAS Number: 50-98-6 Other descriptive name: EPHEDRINE HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Leiden University Medical Center | Authorised | Female: yes Male: yes | Netherlands | |||||
| 53 | EUCTR2013-005362-19-DE | 17/07/2014 | 17 July 2017 | 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] | Trade Name: Velcade® Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: BORTEZOMIB CAS Number: 179324-69-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3,5- | Charité - Universitätsmedizin Berlin | Authorised | Female: yes Male: yes | Phase 2 | Germany | ||||
| 54 | NCT02110706 | May 2014 | 11 June 2018 | 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 | Not recruiting | 21 Years | 90 Years | All | 52 | Phase 2 | United States | |
| 55 | ChiCTR-OCC-14004533 | 2014-04-30 | 18 April 2017 | 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 | Not Recruiting | 10 | 66 | Both | volunteer:30;MG group:30; | Other | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT01997229 | December 2013 | 29 July 2019 | 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 | Not recruiting | 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 | |
| 57 | JPRN-UMIN000012089 | 2013/10/15 | 21 May 2019 | 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 Neurology University of Tokyo, Graduate School of Medicine | Not Recruiting | 20years-old | 80years-old | Male and Female | 5 | Not selected | Japan | |
| 58 | NCT01480596 | April 2013 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 40 | Phase 2 | United States;Canada;Germany;Italy | |
| 59 | ChiCTR-OCC-13003090 | 2012-12-20 | 18 April 2017 | 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 | Not Recruiting | 18 | 65 | Both | experimental group:30;control group:30; | Pilot study | China | |
| 60 | NCT01765140 | December 2012 | 25 February 2019 | Treatment Use of 3,4-Diaminopyridine | Treatment Use of 3,4-Diaminopyridine in Lambert-Eaton Myasthenia and Congenital Myasthenia Gravis | Lambert Eaton Myasthenic Syndrome (LEMS);Myasthenic Syndromes, Congenital | Drug: 3,4-diaminopyridine | Vern C. Juel, M.D. | Not recruiting | N/A | N/A | All | Phase 1/Phase 2 | United States | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | EUCTR2012-001544-21-ES | 07/11/2012 | 3 December 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 Pharmaceutical Form: Solution for infusion CAS Number: 308067-58-5 Other descriptive name: IMMUNOGLOBULIN G Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Vall d'Hebron Institut de Recerca (VHIR) | Authorised | Female: yes Male: yes | 84 | Spain | ||||
| 62 | NCT01727193 | September 2012 | 30 September 2019 | 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 | Recruiting | 12 Years | 65 Years | All | 158 | Phase 3 | China | ||
| 63 | JPRN-UMIN000007671 | 2012/04/01 | 2 April 2019 | 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 | Recruiting | 50years-old | Not applicable | Male and Female | 40 | Not applicable | Japan | ||
| 64 | JPRN-UMIN000007679 | 2012/04/01 | 2 April 2019 | 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 | Recruiting | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan | ||
| 65 | NCT01555580 | April 2012 | 19 February 2015 | 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 | Not recruiting | 18 Years | 80 Years | Both | 12 | Phase 0 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | NCT00995722 | December 2011 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 11 | Phase 3 | United States;Canada |
| 67 | EUCTR2011-002068-26-DE | 24/11/2011 | 16 November 2015 | 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 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: belimumab CAS Number: 356547-88-1 Current Sponsor code: GSK1550188 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 80- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | GlaxoSmithKline Research & Development Limited | Not Recruiting | Female: yes Male: yes | 42 | United States;Canada;Germany;Italy | ||||
| 68 | NCT01828294 | October 2011 | 15 April 2019 | Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis | Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis | Myasthenia Gravis | Drug: Subcutaneous immunoglobulins | St. Louis University | CSL Behring | Not recruiting | 18 Years | 80 Years | All | 4 | Phase 1 | United States |
| 69 | NCT01325571 | March 2011 | 11 April 2016 | 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. | Not recruiting | 18 Years | 70 Years | Both | 83 | Phase 3 | China |
| 70 | NCT01268280 | December 2010 | 30 September 2019 | 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) | Not recruiting | 18 Years | 80 Years | All | 32 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | ChiCTR-TRC-13004125 | 2010-10-01 | 18 April 2017 | 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 | Not Recruiting | 14 | 75 | Both | trial:30;Control:30; | Phase 1+Phase 2 | China | |
| 72 | EUCTR2009-014669-13-GB | 29/12/2009 | 19 March 2012 | 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: eculizumab CAS Number: 219685-50-4 Current Sponsor code: h5G1.1-mAb Other descriptive name: Anti-C5 antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | Alexion Pharmaceuticals Inc. | Not Recruiting | Female: yes Male: yes | 24 | United Kingdom | ||||
| 73 | NCT00987116 | June 2009 | 16 December 2017 | 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 | Not recruiting | 18 Years | 80 Years | All | 118 | Phase 4 | France | |
| 74 | NCT00997412 | May 2009 | 19 February 2015 | 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. | Not recruiting | 20 Years | 70 Years | Both | 40 | N/A | ||
| 75 | NCT00814138 | April 2009 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 50 | Phase 2 | United States;Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | NCT00727194 | October 2008 | 30 September 2019 | 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 | Not recruiting | 18 Years | 80 Years | All | 14 | Phase 2 | United States;Canada;United Kingdom | |
| 77 | EUCTR2007-002817-37-IT | 29/07/2008 | 19 March 2012 | 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 Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: pixantrone Current Sponsor code: BBR 2778 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solvent for parenteral use Route of administration of the placebo: Intravenous use | ISTITUTO NEUROLOGICO CARLO BESTA | Authorised | Female: yes Male: yes | Phase 2 | Italy | ||||
| 78 | EUCTR2007-001377-28-FR | 11/06/2008 | 19 March 2012 | 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 newly diagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1 Level: LLT Classification code 10061664 Term: Autoimmune disorder MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic MedDRA version: 9.1 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis MedDRA version: 9.1 Level: LLT Classification code 10002817 Term: Antiphospholipid syndrome MedDRA version: 9.1 Level: LLT Classification code 10040767 Term: Sjogren's syndrome MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative MedDRA version: 9.1 Level: LLT Classification code 10003827 Term: Autoimmune hepatitis MedDRA version: 9.1 Level: LLT Classification code 10049046 Term: Autoimmune thyroiditis MedDRA version: 9.1 Level: LLT Classification code 10003822 Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1 Level: LLT Classification code 10034697 Term: Pernicious anemia MedDRA version: 9.1 Level: LLT Classification code 10028417 Term: Myasthenia gravis MedDRA version: 9.1 Level: LLT Classification code 10018620 Term: Goodpasture's syndrome MedDRA version: 9.1 Level: LLT Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | Merck Serono International S.A. | Authorised | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | |||
| 79 | NCT00716066 | June 2008 | 9 September 2019 | Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune Diseases | High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases | Autoimmune Disease;Neurologic Autoimmune Disease;Autologous Transplant Autoimmune;Multiple Sclerosis Transplant;MS Stem Cell Transplant;Multiple Sclerosis Stem Cell Transplant;Stiff Person Syndrome;HCT for Neurologic Autoimmune Disorders;CIDP Transplant;Myasthenia Gravis Transplant | Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Carmustine;Drug: Cytarabine;Drug: Etoposide;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Prednisone;Procedure: Syngeneic Bone Marrow Transplantation | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) | Recruiting | N/A | 70 Years | All | 40 | Phase 2 | United States |
| 80 | NCT00774462 | January 2008 | 19 February 2015 | 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 | Not recruiting | 18 Years | 80 Years | Both | 30 | Phase 2 | France |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | NCT00515450 | July 2007 | 19 February 2015 | 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 | Not recruiting | 16 Years | N/A | Both | 46 | Phase 3 | Japan | |
| 82 | NCT01179893 | March 2007 | 19 February 2015 | 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. | Not recruiting | 18 Years | N/A | Both | 87 | Phase 4 | Canada |
| 83 | EUCTR2006-004374-27-DE | 12/10/2006 | 19 March 2012 | 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 Pharmaceutical Form: Suspension for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use | Philipps-University | Not Recruiting | Female: yes Male: yes | Germany | |||||
| 84 | NCT00294658 | June 2006 | 16 December 2017 | 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) | Not recruiting | 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 |
| 85 | NCT00309088 | April 2006 | 19 February 2015 | 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 | Not recruiting | 16 Years | 64 Years | Both | 80 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | EUCTR2005-002740-26-GB | 21/02/2006 | 18 April 2012 | 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 | Product Name: MONARSEN Product Code: EN101 Pharmaceutical Form: Oral solution Current Sponsor code: EN101 Other descriptive name: MONARSEN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Current Sponsor code: EN101 Other descriptive name: MONARSEN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Current Sponsor code: EN101 Other descriptive name: MONARSEN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | Ester Neuroscience Ltd | Authorised | Female: yes Male: yes | 30 | Phase 2 | United Kingdom | |||
| 87 | NCT00309101 | February 2006 | 19 February 2015 | 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 | Not recruiting | 16 Years | 64 Years | Both | 11 | Phase 3 | Japan | |
| 88 | EUCTR2005-000343-28-DE | 19/12/2005 | 10 February 2014 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: mycophenolate mofetil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Aspreva Pharmaceuticals Corporation | Not Recruiting | Female: yes Male: yes | 136 | Spain;Germany;Italy;United Kingdom | ||||
| 89 | EUCTR2004-000596-34-CZ | 19/05/2005 | 19 March 2012 | 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 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | F.Hoffmann-La Roche Ltd. | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;Spain;Italy | ||||
| 90 | NCT00683969 | August 2004 | 19 February 2015 | 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 | Not recruiting | 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_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | NCT00408213 | June 2004 | 19 February 2015 | 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 | Not recruiting | 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 |
| 92 | NCT00619671 | April 2004 | 19 February 2015 | 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. | Not recruiting | 18 Years | 80 Years | Both | 10 | Phase 1/Phase 2 | United States |
| 93 | NCT00306033 | March 2004 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 50 | Phase 3 | Canada | |
| 94 | NCT00285350 | September 2002 | 7 April 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 80 | Phase 3 | |
| 95 | NCT00424489 | February 2002 | 8 August 2016 | 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 | Northwestern University | Not recruiting | 15 Years | 65 Years | Both | 9 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 96 | NCT00004682 | March 1995 | 7 April 2015 | Randomized Study of Intravenous Immunoglobulin in Patients With Mild or Moderate Myasthenia Gravis | Myasthenia Gravis | Drug: immune globulin | University of Texas | Not recruiting | 15 Years | N/A | Both | 100 | N/A |