↑ 疾患リストへ ← 戻る

 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.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04146051November 1, 201911 November 2019Descartes-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, GeneralizedDrug: Descartes-08Cartesian TherapeuticsRecruiting18 YearsN/AAll18Phase 1/Phase 2United States
2NCT04115293October 1, 201922 October 2019Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: zilucoplan (RA101495);Drug: PlaceboRa PharmaceuticalsRecruiting18 Years75 YearsAll130Phase 3United States
3NCT04124965October 201928 October 2019A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisMyasthenia GravisDrug: RozanolixizumabUCB Biopharma S.P.R.L.Not recruiting18 YearsN/AAll240Phase 3
4NCT03896295August 6, 201911 November 2019An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia GravisAn Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: M281Momenta Pharmaceuticals, Inc.Recruiting18 YearsN/AAll60Phase 2United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom
5NCT03971422June 3, 201911 November 2019A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisMyasthenia GravisDrug: Rozanolixizumab;Other: PlaceboUCB Biopharma S.P.R.L.Recruiting18 YearsN/AAll240Phase 3United States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03863080May 21, 201911 November 2019A Study of RVT-1401 in Myasthenia Gravis (MG) PatientsA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis PatientsMyasthenia GravisDrug: RVT-1401;Drug: PlaceboImmunovant Sciences GmbHRecruiting18 YearsN/AAll21Phase 2United States;Canada
7NCT03914638April 201929 April 2019Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia GravisBeta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia GravisMyasthenia GravisDrug: Salbutamol 4Mg Tablet;Drug: Placebo oral capsuleUniversity of AarhusRecruiting18 YearsN/AAll50Phase 2/Phase 3Denmark
8NCT03920293March 26, 20194 November 2019Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia GravisA 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 GravisGeneralized Myasthenia GravisBiological: Ravulizumab;Drug: PlaceboAlexion PharmaceuticalsRecruiting18 YearsN/AAll160Phase 3United States;Canada;Italy;Japan;Korea, Republic of;Spain;Switzerland
9NCT03770403March 1, 201922 October 2019A 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 WeaknessGeneralized Myasthenia GravisBiological: ARGX-113argenx BVBARecruiting18 YearsN/AAll150Phase 3United States;Belgium;Czechia;Denmark;Italy;Japan;Poland
10NCT03759366December 21, 20182 September 2019A 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 GravisMyasthenia Gravis;Myasthenia Gravis, Juvenile Form;Myasthenia Gravis, GeneralizedDrug: EculizumabAlexion PharmaceuticalsRecruiting6 Years17 YearsAll12Phase 3United States;Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11ChiCTR18000175642018-09-0820 August 2018Optimal Timing of Thymectomy in Nonthymomatous Myasthenia Gravis Patients In China: A Follow-up Prospective StudyOptimal Timing of Thymectomy in Nonthymomatous Myasthenia Gravis Patients In China: A Prospective StudyMyasthenia GravisExperiment 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 MedicineNot Recruiting180BothExperiment group versus Control group:822;OtherChina
12NCT03669588September 5, 201814 October 2019An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle WeaknessA 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 WeaknessGeneralized Myasthenia GravisBiological: ARGX-113;Biological: Placeboargenx BVBARecruiting18 YearsN/AAll150Phase 3United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Serbia;United Kingdom
13NCT03579966July 1, 201826 August 2019Long 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 GravisMyasthenia Gravis, MuSKDrug: Amifampridine PhosphateCatalyst Pharmaceuticals, Inc.Recruiting18 YearsN/AAll70Phase 3United States
14NCT03165435July 201811 June 2018A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia GravisA 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, GeneralizedBiological: CV-MG01;Biological: PlaceboCuraVacAepodia;University Hospital, AntwerpNot recruiting18 YearsN/AAll0Phase 2/Phase 3Belgium;Netherlands
15NCT03490539May 7, 20188 April 2019Disease-Modifying Treatments for Myasthenia GravisProspective Multicenter Observational Cohort Study of Comparative Effectiveness of Disease-modifying Treatments for Myasthenia GravisNeurological Disorder;Autoimmune DiseasesDrug: Mycophenolate Mofetil;Drug: AzathioprineDuke UniversityBeth Israel Deaconess Medical Center;Patient-Centered Outcomes Research InstituteRecruiting18 YearsN/AAll220N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03510546April 9, 201811 June 2018Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia GravisEffect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia GravisMyasthenia GravisDrug: Pyridostigmine;Drug: Placebo oral capsuleUniversity of AarhusAarhus University HospitalRecruiting18 Years90 YearsAll44Phase 4Denmark
17NCT03304054March 7, 201826 August 2019Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MGA 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 PatientsMyasthenia Gravis, GeneralizedDrug: Amifampridine Phosphate;Drug: Placebo Oral TabletCatalyst Pharmaceuticals, Inc.Recruiting18 YearsN/AAll60Phase 3United States
18ChiCTR19000246922018-01-0129 July 2019Comparison of the efficacy of azathioprine and cyclosporine in myasthenia gravis immune modificationComparison of the efficacy of azathioprine and cyclosporine in myasthenia gravis immune modificationMyasthenia Graviseye 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 ArmyRecruiting380Botheye muscles type:20;eye muscles type:20;eye muscles type:20;non-eye muscle type:20;non-eye muscle type :20;N/AChina
19EUCTR2017-002599-15-DK07/11/20178 January 2018Effect 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 UniversityAuthorisedFemale: yes
Male: yes
32Phase 4Denmark
20NCT03315130October 11, 20171 July 2019Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia GravisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: zilucoplan (RA101495);Drug: PlaceboRa PharmaceuticalsNot recruiting18 Years85 YearsAll44Phase 2United States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2017-000323-27-BE19/06/201721 May 2018A study to evaluate the efficacy of CV-MG01 (Myasterix) in Myasthenia GravisA 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 StudyMyasthenia 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 SANot RecruitingFemale: yes
Male: yes
66Phase 2;Phase 3Belgium;Netherlands
22NCT03052751May 15, 201711 June 2019Study 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 GravisMyasthenia GravisOther: Placebo;Drug: UCB7665UCB Biopharma S.P.R.L.Not recruiting18 YearsN/AAll43Phase 2United States;Spain;Germany;Denmark;Czechia;Canada;Belgium
23NCT03059888April 12, 201725 February 2019Trial of Orencia in Patients With Myasthenia GravisPilot Trial of Orencia in Myasthenia Gravis Patients Inadequately Responsive to Conventional ImmunotherapyMyasthenia GravisDrug: Abatacept InjectionJohns Hopkins UniversityBristol-Myers SquibbRecruiting16 Years85 YearsAll20Early Phase 1United States
24EUCTR2016-002698-36-DE09/02/201718 June 2018Study 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 SPRLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
25NCT04101578February 8, 20177 October 2019Clinical Prognosis and Progression of Myasthenia Gravis PatientsProspective Observational Trial to Evaluate Clinical Prognosis and the Risk Factors for Progression for Myasthenia Gravis PatientsMyasthenia GravisDrug: Symptomatic Treatment, Steroids, Immunosuppressive Agents, Plasma Exchange(PE), Intravenous Immunoglobulin(IVIg)Da, Yuwei, M.D.Recruiting15 YearsN/AAll2000N/AChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT02965573December 30, 20165 November 2018A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle WeaknessA 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 WeaknessMyasthenia GravisBiological: ARGX-113;Drug: Placeboargenx BVBAQuintiles, Inc.Not recruiting18 YearsN/AAll24Phase 2United States;Belgium;Canada;Italy;Netherlands;Poland;Spain;Sweden
27EUCTR2016-002938-73-BE31/10/201611 December 2017A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle WeaknessA 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 WeaknessMyasthenia 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 BVBANot RecruitingFemale: yes
Male: yes
24Phase 2United States;Canada;Poland;Spain;Belgium;Netherlands;Italy;Sweden
28NCT02950155October 16, 201629 April 2019A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia GravisA 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 GravisDrug: Rituximab;Drug: Sodium Chloride solutionFredrik PiehlRecruiting18 YearsN/AAll44Phase 3Sweden
29EUCTR2016-003138-26-NL04/10/201624 October 2016Flu vaccine in patients with Myasthenia GravisInfluenza vaccination in patients with Myasthenia Gravis - Influenza vaccine in Myasthenia GravisMyasthenia 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
LUMCAuthorisedFemale: yes
Male: yes
Phase 4Netherlands
30ChiCTR18000176962016-07-0120 August 2018Effect of Magnesium Sulfate on Muscle Strength in Patients with Myasthenia GravisEffect of Magnesium Sulfate on Muscle Strength in Patients with Myasthenia GravisMyasthenia GravisGroup A:Magnesium Sulfate;Group B:Normal saline;The University of Hong Kong-Shenzhen HospitalRecruiting1860BothGroup A:30;Group B:30;New Treatment Measure Clinical StudyChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2015-005749-30-SE23/06/20166 November 2018A clinical trial investigating the effect and safety of the drug rituximab in patients with new onset myasthenia gravis, an autoimmune condition affecting muscle strenghtA 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 - RinomaxNew 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 InstitutetAuthorisedFemale: yes
Male: yes
60Phase 3Sweden
32NCT02609022March 201611 February 2019Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia GravisA 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 GravisMyasthenia GravisBiological: CV-MG01;Biological: PlaceboCuraVacAepodia;University Hospital, Antwerp;Leiden University Medical CenterNot recruiting18 Years64 YearsAll24Phase 1/Phase 2Belgium
33EUCTR2016-001384-37-DE28 February 2019An 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
17Phase 3United States;Germany;Japan
34EUCTR2015-003127-62-IT02/10/20153 April 2017A Randomized, Placebo-Controlled Study to Evaluate the Effect of Amifampridine in Patients with MuSK Antibody Positive Myasthenia GravisA 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-001Patients 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 BESTAAuthorisedFemale: yes
Male: yes
20Phase 2Italy
35NCT02565576September 29, 201529 July 2019Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia GravisA 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 GravisMyasthenia Gravis, GeneralizedDrug: Placebo;Drug: CFZ533Novartis PharmaceuticalsNot recruiting18 Years85 YearsAll44Phase 2Canada;Denmark;Germany;Russian Federation;Taiwan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2015-000097-35-DE02/09/201528 August 2017Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patientsA 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 gravisAcquired 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 AGNot RecruitingFemale: yes
Male: yes
44Phase 2Taiwan;Canada;Denmark;Russian Federation;Germany
37NCT02473952August 201518 March 2019A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia GravisA 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 GravisMyasthenia Gravis, GeneralizedDrug: IGIV-C;Drug: PlaceboGrifols Therapeutics LLCNot recruiting18 Years85 YearsAll62Phase 2United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic
38EUCTR2013-005099-17-LT07/07/201530 April 2019A 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 GravisMyasthenia 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
60Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
39EUCTR2014-003997-18-LT07/07/201530 April 2018A 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 GravisMyasthenia 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 RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
40NCT02473965June 201513 May 2019Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia GravisA 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 GravisMyasthenia GravisDrug: IGIV-C;Drug: PlaceboGrifols Therapeutics LLCNot recruiting18 Years85 YearsAll60Phase 2United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT02100969May 201511 June 2018Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia GravisOpen Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia GravisMyasthenia GravisDrug: HIZENTRA ®Mazen Dimachkie, MDCSL BehringNot recruiting18 YearsN/AAll25Phase 2United States;Canada
42JPRN-UMIN0000165642015/03/132 April 2019Rituximab for intractable myasthenia gravismyasthenia gravisrituximabTokushima University HospitalNot Recruiting15years-old80years-oldMale and Female1Not selectedJapan
43ChiCTR-IPR-150060812015-03-0218 April 2017A prospective study of combined use of small doses of hormones and methotrexate for the treatment of myasthenia gravisA prospective study of combined use of small doses of hormones and methotrexate for the treatment of myasthenia gravismyasthenia gravisprednisone group:prednisone;Prednisone + methotrexate:Prednisone + methotrexate;Xuan Wu Hospital, Capital Medical UniversityRecruiting1880Bothprednisone group:15;Prednisone + methotrexate:15;Post-market
44NCT02413580March 20159 October 2018A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis ExacerbationsA 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 ExacerbationsMyasthenia Gravis ExacerbationsBiological: IGIV-CGrifols Therapeutics LLCNot recruiting18 YearsN/AAll49Phase 3Latvia;Argentina;Belgium;Canada;Czechia;Estonia;France;Hungary;Poland;Romania;Russian Federation;South Africa;Czech Republic
45EUCTR2014-004344-35-NL16/02/201523 February 2015The effect of tetanus revaccination in patients with myasthenia gravisThe effect of tetanus revaccination in patients with myasthenia gravis - Tetanus revaccination in patients with myasthenia gravisMyasthenia 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 CenterAuthorisedFemale: yes
Male: yes
Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2013-005098-28-CZ16/01/201523 July 2018A 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 exacerbationsMyasthenia 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 RecruitingFemale: yes
Male: yes
50Phase 3France;Hungary;Estonia;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;South Africa;Latvia
47EUCTR2013-002191-41-GB27/10/201423 January 2017EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTSA 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.AuthorisedFemale: yes
Male: yes
92Phase 3United 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
48EUCTR2013-002191-41-BE17/10/201428 February 2019EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTSA 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
92Phase 3United 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
49NCT02102594October 201410 December 2018Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)Myasthenia Gravis;Systemic Lupus Erythematosus;Rheumatoid ArthritisDrug: BortezomibCharite University, Berlin, GermanyProf. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology);NeuroCure Clinical Research Center, Charite, BerlinRecruiting18 Years75 YearsAll18Phase 2Germany
50NCT02774239October 201416 December 2017A 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 ExacerbationMyasthenia GravisDrug: Human normal immunoglobulin G (IgG)University of AlbertaCSL BehringRecruiting18 Years80 YearsAll30Phase 3Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51JPRN-UMIN0000150192014/09/022 April 2019Initial therapy for myasthenia gravis of combined therapy for tacrolimus and IVIGMyasthenia gravisTacrolimus and IVIGKansai medical universityRecruitingNot applicableNot applicableMale and Female20Not applicableJapan
52EUCTR2014-001355-23-NL29/08/20147 October 2014Ephedrine as add-on therapy for patients with myasthenia gravisEphedrine as add-on therapy for patients with myasthenia gravis - Ephedrine for MGmyasthenia 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 CenterAuthorisedFemale: yes
Male: yes
Netherlands
53EUCTR2013-005362-19-DE17/07/201417 July 2017Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB)Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB) - TAVABMyasthenia 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 BerlinAuthorisedFemale: yes
Male: yes
Phase 2Germany
54NCT02110706May 201411 June 2018BeatMG: Phase II Trial of Rituximab In Myasthenia GravisB Cell Targeted Treatment In Myasthenia Gravis (BeatMG): A Phase II Trial of Rituximab In Myasthenia GravisMyasthenia GravisDrug: Rituximab;Drug: PlaceboYale UniversityNot recruiting21 Years90 YearsAll52Phase 2United States
55ChiCTR-OCC-140045332014-04-3018 April 2017The superior anesthetic management scheme during perioperative period for myasthenia gravis patientsThe superior anesthetic management scheme during perioperative period for myasthenia gravis patientsmyasthenia gravisvolunteer:muscle relaxant monitor;MG group:muscle relaxant monitor;Yijishan Hospital, Wannan Medical College, Wuhu 241001, ChinaNot Recruiting1066Bothvolunteer:30;MG group:30;OtherChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT01997229December 201329 July 2019Safety 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 GravisBiological: Eculizumab;Drug: PlaceboAlexion PharmaceuticalsNot recruiting18 YearsN/AAll125Phase 3United 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
57JPRN-UMIN0000120892013/10/1521 May 2019Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical studyTreatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study - Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical studyMuSK antibody-positive myasthenia gravisAdministration 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 MedicineNot Recruiting20years-old80years-oldMale and Female5Not selectedJapan
58NCT01480596April 201319 October 2017The 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 GravisBiological: Belimumab;Other: PlaceboGlaxoSmithKlineNot recruiting18 YearsN/AAll40Phase 2United States;Canada;Germany;Italy
59ChiCTR-OCC-130030902012-12-2018 April 2017Research on micrornas expression of Myasthenia gravis and the relationship with TH1, TH2 cells secrete cytokinesResearch on micrornas expression of Myasthenia gravis and the relationship with TH1, TH2 cells secrete cytokinesMyasthenia gravisexperimental group:Pyridostigmine Bromide;control group:nothing;The first affiliated hospital of Guangzhou university of Traditional Chinese medicineNot Recruiting1865Bothexperimental group:30;control group:30;Pilot studyChina
60NCT01765140December 201225 February 2019Treatment Use of 3,4-DiaminopyridineTreatment Use of 3,4-Diaminopyridine in Lambert-Eaton Myasthenia and Congenital Myasthenia GravisLambert Eaton Myasthenic Syndrome (LEMS);Myasthenic Syndromes, CongenitalDrug: 3,4-diaminopyridineVern C. Juel, M.D.Not recruitingN/AN/AAllPhase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2012-001544-21-ES07/11/20123 December 2012Intravenous 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)AuthorisedFemale: yes
Male: yes
84Spain
62NCT01727193September 201230 September 2019The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand ThymectomyMyasthenia GravisDrug: Azathioprine;Drug: LeflunomideFirst Affiliated Hospital, Sun Yat-Sen UniversityRecruiting12 Years65 YearsAll158Phase 3China
63JPRN-UMIN0000076712012/04/012 April 2019Randomized comparative study on efficacy and safety of reduced-dose steroid combined with tacrolimus vs conventional-dose steroid in late- or elderly-onset myasthenia gravis patientsMyasthenia gravisAdministration of prednisolone 35 mg/day with tacrolimus 3mg a day
Administration of prednisolone 50 mg/day
Department of Neurology, Chiba University Graduate School of MedicineRecruiting50years-oldNot applicableMale and Female40Not applicableJapan
64JPRN-UMIN0000076792012/04/012 April 2019Randomized comparative study on efficacy and safety of tacrolimus, prednisolone or placebo in ocular myasthenia gravis patientsMyasthenia gravisAdministration of tacrolimus 3 mg/day
Administration of prednisolone 5 mg/day
anticholinesterases
Department of Neurology, Chiba University Graduate School of MedicineRecruiting20years-oldNot applicableMale and Female60Not selectedJapan
65NCT01555580April 201219 February 2015A Pilot Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Generalized Myasthenia GravisA Pilot Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Symptomatic Autoimmune Generalized Myasthenia GravisMyasthenia GravisDrug: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)Muscular Dystrophy AssociationNot recruiting18 Years80 YearsBoth12Phase 0United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT00995722December 201116 December 2017Efficacy of Prednisone In the Treatment of Ocular MyastheniaEfficacy of Prednisone In the Treatment of Ocular Myasthenia: The EPITOME' StudyOcular Myasthenia GravisDrug: Prednisone;Drug: PlaceboMichael BenatarUniversity of Miami;University of RochesterNot recruiting18 YearsN/AAll11Phase 3United States;Canada
67EUCTR2011-002068-26-DE24/11/201116 November 2015A 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 LimitedNot RecruitingFemale: yes
Male: yes
42United States;Canada;Germany;Italy
68NCT01828294October 201115 April 2019Subcutaneous Ig Maintenance Therapy for Myasthenia GravisSubcutaneous Ig Maintenance Therapy for Myasthenia GravisMyasthenia GravisDrug: Subcutaneous immunoglobulinsSt. Louis UniversityCSL BehringNot recruiting18 Years80 YearsAll4Phase 1United States
69NCT01325571March 201111 April 2016A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia GravisA 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 TherapyMyasthenia GravisDrug: Tacrolimus capsule;Drug: PlaceboAstellas Pharma IncAstellas Pharma China, Inc.Not recruiting18 Years70 YearsBoth83Phase 3China
70NCT01268280December 201030 September 2019Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia GravisA Phase II, Double-Blind, Randomized, Three-Way Crossover, Placebo-Controlled, Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis on Standard TherapyMyasthenia GravisDrug: Placebo;Drug: 250 mg CK-2017357;Drug: 500 mg CK-2017357CytokineticsNational Institute of Neurological Disorders and Stroke (NINDS)Not recruiting18 Years80 YearsAll32Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71ChiCTR-TRC-130041252010-10-0118 April 2017The study on the pathogenesis of spleen-kidney deficiency type myasthenia gravis and the interference effect of Jianji Ning Granule on the patientsThe study on the pathogenesis of spleen-kidney deficiency type myasthenia gravis and the interference effect of Jianji Ning Granule on the patientsMyasthenia gravistrial:Jianji Ning Granule combined with olfactory pyridostigmine tablets ;Control:olfactory pyridostigmine tablets ;Longhua Hospital Affiliated to Shanghai University of traditional Chinese MedicineNot Recruiting1475Bothtrial:30;Control:30;Phase 1+Phase 2China
72EUCTR2009-014669-13-GB29/12/200919 March 2012A 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. - C08-001A 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. - C08-001Generalized 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 RecruitingFemale: yes
Male: yes
24United Kingdom
73NCT00987116June 200916 December 2017Study Comparing Two Tapering Strategies of Prednisone in Myasthenia GravisComparison of Two Tapering Strategies of Prednisone in Patients With Generalised Myasthenia Gravis Treated With Prednisone and Azathioprine: a Single-blind Randomised Controlled Multicenter StudyMyasthenia GravisDrug: Prednisone - AzathioprineAssistance Publique - Hôpitaux de ParisNot recruiting18 Years80 YearsAll118Phase 4France
74NCT00997412May 200919 February 2015Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia GravisRandomized, Double-blind, Double-dummy Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia GravisMyasthenia GravisDrug: Mycophenolic acid;Drug: AZAQualitix Clinical Research Co., Ltd.Not recruiting20 Years70 YearsBoth40N/A
75NCT00814138April 200919 October 2017Efficacy of Methotrexate in Myasthenia GravisPhase II Trial of Methotrexate in Myasthenia GravisMyasthenia GravisDrug: Methotrexate;Other: PlaceboUniversity of Kansas Medical CenterNot recruiting18 YearsN/AAll50Phase 2United States;Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT00727194October 200830 September 2019Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia GravisA 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 ImmunosuppressantsMyasthenia GravisDrug: eculizumab;Drug: PlaceboAlexion PharmaceuticalsNot recruiting18 Years80 YearsAll14Phase 2United States;Canada;United Kingdom
77EUCTR2007-002817-37-IT29/07/200819 March 2012A PHASE II, PLACEBO CONTROLLED, DOSE FINDING PILOT STUDY OF PIXANTRONE EFFICACY ADMINISTERED INTRAVENOUSLY IN PATIENTS AFFECTED WITH MYASTHENIA GRAVIS - NDA PHASE II, PLACEBO CONTROLLED, DOSE FINDING PILOT STUDY OF PIXANTRONE EFFICACY ADMINISTERED INTRAVENOUSLY IN PATIENTS AFFECTED WITH MYASTHENIA GRAVIS - NDPatients 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 BESTAAuthorisedFemale: yes
Male: yes
Phase 2Italy
78EUCTR2007-001377-28-FR11/06/200819 March 2012Phase 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™-TRAILPhase 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™-TRAILAdult 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.AuthorisedFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
79NCT00716066June 20089 September 2019Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune DiseasesHigh-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic DiseasesAutoimmune 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 TransplantBiological: 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 TransplantationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)RecruitingN/A70 YearsAll40Phase 2United States
80NCT00774462January 200819 February 2015Rituximab for the Treatment of Refractory Inflammatory Myopathies and Refractory Myasthenia GravisFORCE: Rituximab (CD 20+-B Cell-depleting Monoclonal Antibody) for the Treatment of Refractory Inflammatory Myopathies With Specific Antibodies and Refractory Myasthenia GravisMyositis;Myasthenia GravisDrug: RituximabAssistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, France;Roche Pharma AGNot recruiting18 Years80 YearsBoth30Phase 2France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT00515450July 200719 February 2015Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia GravisA Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia GravisGeneralized Myasthenia GravisBiological: GB-0998 (Intravenous immunoglobulin);Procedure: PlasmapheresisBenesis CorporationNot recruiting16 YearsN/ABoth46Phase 3Japan
82NCT01179893March 200719 February 2015Intravenous Immunoglobulin and Plasma Exchange in Myasthenia GravisA Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia GravisMyasthenia GravidBiological: IVIG;Procedure: PLEXUniversity Health Network, TorontoGrifols Therapeutics Inc.Not recruiting18 YearsN/ABoth87Phase 4Canada
83EUCTR2006-004374-27-DE12/10/200619 March 2012Prospective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIentProspective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIentGeneralized 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-UniversityNot RecruitingFemale: yes
Male: yes
Germany
84NCT00294658June 200616 December 2017Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone TherapyA Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving PrednisoneMyasthenia GravisProcedure: thymectomy plus prednisone;Drug: prednisone aloneUniversity of Alabama at BirminghamNational Institute of Neurological Disorders and Stroke (NINDS)Not recruiting18 Years65 YearsAll126Phase 3United States;Argentina;Australia;Brazil;Canada;Chile;Germany;Italy;Japan;Mexico;Netherlands;Poland;Portugal;South Africa;Spain;Taiwan;Thailand;United Kingdom;Ireland
85NCT00309088April 200619 February 2015FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) PatientsFK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis PatientsMyasthenia GravisDrug: tacrolimus;Drug: placeboAstellas Pharma IncNot recruiting16 Years64 YearsBoth80Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2005-002740-26-GB21/02/200618 April 2012A 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 GravisA 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 GravisMyasthenia 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 LtdAuthorisedFemale: yes
Male: yes
30Phase 2United Kingdom
87NCT00309101February 200619 February 2015An Open Study for Steroid Resistant, Non-Thymectomized MG PatientsFK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG PatientsMyasthenia GravisDrug: tacrolimusAstellas Pharma IncNot recruiting16 Years64 YearsBoth11Phase 3Japan
88EUCTR2005-000343-28-DE19/12/200510 February 2014An 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 CorporationNot RecruitingFemale: yes
Male: yes
136Spain;Germany;Italy;United Kingdom
89EUCTR2004-000596-34-CZ19/05/200519 March 2012A 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 gravisA 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 gravisMyasthenia 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 RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;Spain;Italy
90NCT00683969August 200419 February 2015A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia GravisA 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 GravisMyasthenia Gravis, GeneralizedDrug: mycophenolate mofetil (CellCept);Drug: placeboHoffmann-La RocheAspreva PharmaceuticalsNot recruiting18 Years80 YearsBoth136Phase 3United States;Canada;Former Serbia and Montenegro;France;Germany;India;Israel;Italy;Mexico;Netherlands;Russian Federation;Spain;Ukraine;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT00408213June 200419 February 2015A 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 PrednisoneMyasthenia Gravis GeneralisedDrug: mycophenolate mofetil [CellCept];Drug: PlaceboHoffmann-La RocheAspreva PharmaceuticalsNot recruiting18 Years80 YearsBoth136Phase 3United States;Former Serbia and Montenegro;France;Germany;Italy;Ukraine;United Kingdom;Israel;Spain;Canada;Czech Republic;Mexico;Netherlands
92NCT00619671April 200419 February 2015A Pilot Trial of Rituxan in Refractory Myasthenia GravisPhase 1-2 Pilot Study of Rituximab (Rituxan) in Refractory Myasthenia Gravis.Refractory Myasthenia GravisDrug: Rituximab (Rituxan)University of VermontGenentech, Inc.Not recruiting18 Years80 YearsBoth10Phase 1/Phase 2United States
93NCT00306033March 200419 February 2015Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia GravisIVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical TrialMyasthenia GravisDrug: Intravenous ImmuneGlobulinUniversity Health Network, TorontoNot recruiting18 YearsN/ABoth50Phase 3Canada
94NCT00285350September 20027 April 2015Mycophenolate Mofetil in Myasthenia GravisA Trial of Mycophenolate Mofetil in Myasthenia GravisMyasthenia GravisDrug: mycophenolate mofetilFDA Office of Orphan Products DevelopmentDuke UniversityNot recruiting18 YearsN/ABoth80Phase 3
95NCT00424489February 20028 August 2016Hematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia GravisHematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia GravisMyasthenia GravisBiological: Hematopoietic Stem Cell TransplantationNorthwestern UniversityNot recruiting15 Years65 YearsBoth9Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT00004682March 19957 April 2015Randomized Study of Intravenous Immunoglobulin in Patients With Mild or Moderate Myasthenia GravisMyasthenia GravisDrug: immune globulinUniversity of TexasNot recruiting15 YearsN/ABoth100N/A

先頭へ