13. 多発性硬化症/視神経脊髄炎 [臨床試験数:3,050,薬物数:2,147(DrugBank:348),標的遺伝子数:244,標的パスウェイ数:228

Searched query = "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
2737 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04660539January 11, 202124/11/2020A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica Spectrum DisorderDrug: satralizumab;Drug: azathioprine (AZA);Drug: mycophenolate mofetil (MMF);Drug: oral corticosteroidsHoffmann-La RocheNULLNot yet recruiting18 YearsN/AAll127Phase 3United States;Bulgaria;Canada;Croatia;Germany;Hungary;Italy;Japan;Korea, Republic of;Malaysia;Poland;Puerto Rico;Romania;Spain;Taiwan;Turkey;Ukraine;United Kingdom
2NCT04650321January 1, 202116/11/2020Home Based Infusions for OcrelizumabEvaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based InfusionsMultiple SclerosisDrug: Ocrelizumab at homeUniversity of Colorado, DenverGenentech, Inc.Not yet recruiting18 Years55 YearsAll110Phase 4NULL
3NCT04586023December 26, 20208/10/2020Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS)A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: fenebrutinib;Drug: teriflunomide;Drug: placeboHoffmann-La RocheNULLRecruiting18 Years55 YearsAll734Phase 3United States
4EUCTR2020-000647-30-NL23/12/202016/09/2020NRSPMS study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan
5EUCTR2020-000644-55-FR22/12/202015/06/2020RMS study of BTK inhibitor SAR442168 (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2020-003995-42-DE18/12/202029/10/2020Extension to the MAGNIFY MS trial on Mavenclad®A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: CLADRIBINE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
256Phase 4Canada;Finland;Australia;Israel;Germany
7NCT04586010December 18, 20208/10/2020A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS)A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: fenebrutinib;Drug: teriflunomide;Drug: placeboHoffmann-La RocheNULLRecruiting18 Years55 YearsAll734Phase 3United States
8EUCTR2019-003919-53-GB17/12/202026/11/2020FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple SclerosisA PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH OCRELIZUMAB IN ADULT PATIENTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary Progressive multiple sclerosis
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: fenebrutinib
Product Code: RO7010939
INN or Proposed INN: FENEBRUTINIB
Other descriptive name: GDC-0853 RO7010939
Trade Name: Ocrevus
Product Name: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
946Phase 3United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;France;Denmark;Australia;Peru;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
9NCT04544436December 15, 20204/9/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab;Drug: Antihistamine;Drug: MethylprednisoloneHoffmann-La RocheNULLRecruiting18 Years55 YearsAll786Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom
10NCT04548999December 3, 20209/9/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab;Drug: Antihistamine;Drug: MethylprednisoloneHoffmann-La RocheNULLRecruiting18 Years55 YearsAll699Phase 3United States;Argentina;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Mexico;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-005038-39-GB02/12/202029/09/2020A phase 2b study of Cladribine to halt deterioration in people with advanced multiple sclerosisChariotMS – A national (UK), multi-centre, randomised, double-blind, placebo-controlled (1:1) phase IIb efficacy trial with cost-utility analysis of cladribine tablets (3.5mg/kg over two years) in people with advanced multiple sclerosis (EDSS 6.5-8.5). Is cladribine superior to placebo in protecting upper limb function? - ChariotMS - Cladribine for people with advanced multiple sclerosis Advanced Multiple Sclerosis (EDSS 6.5-8.5)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: HLTClassification code 10052785Term: Multiple sclerosis acute and progressiveSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10078558Term: Multiple sclerosis plaqueSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 22.1Level: LLTClassification code 10028246Term: Multiple sclerosis aggravatedSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10078559Term: Multiple sclerosis brain lesionSystem Organ Class: 10028245 - Multiple sclerosis
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: LLTClassification code 10064137Term: Progression of multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10053395Term: Progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10053395Term: Progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10067063Term: Progressive relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification co;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: MAVENCLAD
INN or Proposed INN: Cladribine
Queen Mary University of LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United Kingdom
12NCT04640818November 30, 202018/11/2020Safety and Efficacy of Cladribine Therapy After Anti CD20 TherapySafety and Efficacy of a Therapy With Cladribine Following a Treatment With Anti CD20 Compounds in Relapsing Multiple Sclerosis Patients: a Pilot StudyMultiple SclerosisDrug: Cladribine Oral Tablet;Drug: Rituximab;Drug: OcrelizumabClaudio GobbiMerck AG SwitzerlandNot yet recruiting18 Years80 YearsAll45Switzerland
13EUCTR2019-004857-10-FI20/11/202003/11/2020To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple SclerosisA PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS Relapsing multiple sclerosis (RMS)
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: fenebrutinib
Product Code: RO7010939
INN or Proposed INN: FENEBRUTINIB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Genentech, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
734Phase 3United States;France;Finland;Netherlands
14EUCTR2019-001967-58-FR20/11/202027/05/2020Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with Relapsing Multiple Sclerosis (RMS)A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active-Reference (Ocrelizumab), Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous Dapirolizumab Pegol (BIIB133) in Relapsing Multiple Sclerosis - Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with RMS Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dapirolizumab Pegol
Product Code: BIIB133
INN or Proposed INN: DAPIROLIZUMAB PEGOL
Trade Name: Ocrevus
Product Name: OCREVUS
INN or Proposed INN: OCRELIZUMAB
Other descriptive name: OCRELIZUMAB
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 2United States;Serbia;France;Spain;Poland;Belgium;Germany;Switzerland;Italy
15EUCTR2020-000637-41-FI19/11/202007/09/2020RMS study of BTK inhibitor SAR442168 (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Taiwan;Estonia;Hong Kong;Finland;Spain;Ukraine;Turkey;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Mexico;Canada;Poland;Romania;Denmark;Bulgaria;Germany;China;Japan;Sweden;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2020-000644-55-NL09/11/202010/09/2020RMS study of BTK inhibitor SAR442168 (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;India;France;Netherlands;Latvia;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway
17EUCTR2019-004972-20-FI06/11/202004/09/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3United States;Serbia;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
18EUCTR2019-004972-20-DE05/11/202011/05/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany;United States;Serbia;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Denmark;Australia;Netherlands;Bosnia and Herzegovina
19EUCTR2020-000645-14-EE03/11/202024/08/2020PPMS Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Serbia;Portugal;Belarus;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
20NCT04601142October 31, 202015/10/2020Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica (NMO) and Gene PolymorphismStudy on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort StudyGlucocorticoid Resistance;Gene;Neuromyelitis OpticaDrug: MethylprednisoloneBeijing Tongren HospitalNULLRecruiting16 Years80 YearsAll350China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2020-000645-14-GR29/10/202026/10/2020PPMS Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
22EUCTR2020-000893-69-PL28/10/202009/07/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS Relapsing Multiple Sclerosis (MS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
786Phase 3United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Peru;Netherlands;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
23NCT04544449October 26, 20204/9/2020A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple SclerosisA Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Patients With Primary Progressive Multiple Sclerosis.Multiple Sclerosis, Primary ProgressiveDrug: fenebrutinib;Drug: ocrelizumab;Drug: placeboHoffmann-La RocheNULLRecruiting18 Years65 YearsAll946Phase 3United States;Canada;France;Argentina;Australia;Austria;Belgium;Brazil;Czechia;Denmark;Germany;Greece;Hungary;Israel;Italy;Mexico;New Zealand;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom
24EUCTR2020-000893-69-BE23/10/202023/10/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS Relapsing Multiple Sclerosis (MS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
786Phase 3United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
25EUCTR2019-004980-36-LT22/10/202025/05/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Latvia;Kuwait;Tunisia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2020-000647-30-LT22/10/202014/09/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan
27EUCTR2020-000637-41-LT22/10/202009/09/2020RMS study of BTK inhibitor SAR442168 (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Belarus;Taiwan;Hong Kong;Estonia;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Turkey;Lithuania;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden
28EUCTR2020-000645-14-DK21/10/202016/10/2020PPMS Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
29EUCTR2019-001829-26-DE19/10/202008/01/2020A Trial to Evaluate the Safety and Activity of Eculizumab in PediatricPatients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1Level: LLTClassification code 10077879Term: Neuromyelitis optica spectrum disorder relapseSystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Soliris
Product Name: Soliris
Product Code: Soliris
INN or Proposed INN: ECULIZUMAB
Other descriptive name: h5G1.1-mAb
Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Phase 2;Phase 3United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of
30EUCTR2020-000645-14-GB16/10/202007/10/2020Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2020-000637-41-SE16/10/202007/09/2020RMS study of BTK inhibitor SAR442168 (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Belarus;Taiwan;Estonia;Hong Kong;Finland;Spain;Ukraine;Turkey;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Mexico;Canada;Poland;Romania;Denmark;Bulgaria;Germany;Japan;China;Sweden
32EUCTR2020-000645-14-FR13/10/202027/07/2020PPMS Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
33EUCTR2020-000647-30-FI13/10/202010/09/2020NRSPMS study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan
34EUCTR2019-004980-36-BG12/10/202019/06/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3United States;Belarus;Portugal;Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Latvia;Kuwait;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
35EUCTR2020-000894-26-PT12/10/202013/07/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary Progressive Multiple Sclerosis (MS)
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
699Phase 3Portugal;United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT04480853October 12, 202017/7/2020Safety and Efficacy Study of Fingolimod in Taiwanese Adults (= 20years) With Relapsing Remitting Multiple SclerosisA 12-month, Prospective, Multi-center Post-authorization Commitment (PAC) Study Monitoring Safety in Adult Patients With Relapsing-remitting Multiple Sclerosis Newly Initiated on Gilenya (Fingolimod) in Taiwan (SPRING)Multiple SclerosisDrug: FingolimodNovartis PharmaceuticalsNULLRecruiting20 YearsN/AAll30Phase 4Taiwan
37EUCTR2020-000893-69-PT12/10/202009/07/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS Relapsing Multiple Sclerosis (MS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
786Phase 3United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
38EUCTR2020-000893-69-HU09/10/202006/08/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS Relapsing Multiple Sclerosis (MS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
786Phase 3United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
39EUCTR2020-000637-41-DK08/10/202009/09/2020RMS study of BTK inhibitor SAR442168 (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Belarus;Taiwan;Estonia;Hong Kong;Finland;Spain;Ukraine;Turkey;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Mexico;Canada;Poland;Romania;Denmark;Bulgaria;Germany;China;Japan;Sweden
40EUCTR2020-000894-26-FR08/10/202011/08/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary Progressive Multiple Sclerosis (MS)
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
699Phase 3United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2020-000647-30-DK08/10/202011/09/2020NRSPMS study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan;United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Finland;Turkey;Lithuania;Austria;United Kingdom
42EUCTR2020-000644-55-CZ07/10/202003/09/2020RMS study of BTK inhibitor SAR442168 (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway
43NCT04267926October 6, 202011/2/2020MitoQ for Fatigue in Multiple Sclerosis (MS)MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled TrialMultiple Sclerosis;FatigueDrug: 20 mg MitoQ;Drug: Placebo;Drug: 40mg of MitoQVA Office of Research and DevelopmentNULLRecruiting18 Years70 YearsAll60Phase 1/Phase 2United States
44EUCTR2020-000645-14-BG01/10/202028/07/2020Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Estonia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden;Portugal;Belarus;Serbia;United States
45NCT04565431October 202025/8/2020Examining Effects of Tysabri on Cognitive Fatigue Using fMRIBiomarker for Cognitive Fatigue Using Functional Imaging in Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: TysabriKessler FoundationSt. Barnabas Medical CenterNot yet recruiting18 Years64 YearsAll25United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT04448977October 202015/6/2020Examining Effects of Ocrevus on Cognitive Fatigue Using fMRIA Biomarker for Cognitive Fatigue Using Functional Imaging in MSMultiple Sclerosis, Relapsing-RemittingDrug: OcrevusKessler FoundationHackensack Meridian HealthNot yet recruiting18 Years64 YearsAll60United States
47EUCTR2019-004980-36-DE29/09/202008/09/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Latvia;Kuwait;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden;United States;Belarus;Portugal
48EUCTR2020-000893-69-GB25/09/202029/07/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS - BN42082 Study to evaluate high dose Ocrelizumab in RMS Relapsing Multiple sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrevus
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
786Phase 3United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
49EUCTR2020-000894-26-GB25/09/202030/07/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a HigherDose of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - BN42083 Study to evaluate high dose Ocrelizumab in PPMS Relapsing Multiple Sclerosis (MS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrevus
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
786Phase 3United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand
50NCT04411641September 24, 202028/5/2020Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor SAR442168A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple SclerosisSecondary Progressive Multiple SclerosisDrug: SAR442168;Drug: Placebo to match SAR442168SanofiNULLRecruiting18 Years60 YearsAll1290Phase 3United States;Australia;Bulgaria;Canada;Poland;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2019-004972-20-BG23/09/202019/06/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Hong Kong;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany;United States;Serbia;Taiwan;Estonia
52EUCTR2020-000894-26-HU22/09/202006/08/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary Progressive Multiple Sclerosis (MS)
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
699Phase 3United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand
53EUCTR2020-000644-55-LV21/09/202004/09/2020RMS study of BTK inhibitor SAR442168 (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Chile;Israel;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway;United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine
54EUCTR2020-000644-55-GR18/09/202010/09/2020RMS study of BTK inhibitor SAR442168 (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway
55EUCTR2020-000647-30-DE16/09/202029/06/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Denmark;Australia;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan;United States;Belarus
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT04528121September 15, 202022/8/2020Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple SclerosisEffect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingOther: CoDuSe balance training and step square exercises;Other: conventional balance trainingLama Saad El-Din MahmoudNULLRecruiting20 Years40 YearsAll52N/AEgypt
57EUCTR2020-000647-30-GR15/09/202015/09/2020NRSPMS study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan
58EUCTR2019-004980-36-LV14/09/202001/06/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3United States;Belarus;Portugal;Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Kuwait;Latvia;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
59EUCTR2019-001341-40-AT10/09/202007/07/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
60EUCTR2020-000647-30-GB09/09/202007/09/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Denmark;Australia;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2020-000644-55-GB04/09/202003/09/2020RMS study of BTK inhibitor SAR442168 (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway
62NCT04580381September 1, 20202/10/2020Real World Effectiveness of Natalizumab Extended Interval Dosing in a French CohortReal World Effectiveness of Natalizumab Extended Interval Dosing in Relapsing-Remitting Multiple Sclerosis in a French CohortMultiple Sclerosis, Relapsing-RemittingDrug: Natalizumab Injection [Tysabri]University Hospital, CaenBiogenRecruiting18 YearsN/AAll500France
63NCT02912897September 202013/9/2016Trial to Assess the Safety and Feasibility of Adoptive Cell Therapy With Autologous EBV-specific Cytotoxic T Lymphocytes (CTL) in Patients With a First Clinical Episode Highly Suggestive of Multiple SclerosisAn Open Single-center, Phase I Proof of Concept Trial to Assess the Safety and Feasibility of Adoptive Cell Therapy With Autologous EBV-specific Cytotoxic T Lymphocytes (CTL) in Patients With a First Clinical Episode Highly Suggestive of Multiple SclerosisMultiple SclerosisBiological: Cellular therapy with EBV specific autologous CTL infusionNantes University HospitalNULLNot yet recruiting18 Years45 YearsAll7Phase 1France
64EUCTR2020-000647-30-BG27/08/202016/06/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan;United Kingdom;Czech Republic;Hungary;Canada;Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria
65EUCTR2019-003625-16-HR26/08/202012/11/2020An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple SclerosisAn Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ublituximab
Product Code: TG-1101
INN or Proposed INN: UBLITUXIMAB
Other descriptive name: LFB-R603, TGTX1101
TG Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Belarus;Poland;Ukraine;Romania;Croatia;Russian Federation;Georgia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2019-004972-20-AT26/08/202026/05/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3United States;Serbia;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
67NCT04458051August 13, 20201/7/2020Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor SAR442168 (PERSEUS)A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)Primary Progressive Multiple SclerosisDrug: SAR442168;Drug: PlaceboSanofiNULLRecruiting18 Years55 YearsAll990Phase 3United States;Bulgaria;Canada;Poland;Spain
68EUCTR2020-000637-41-BG11/08/202015/07/2020RMS study of BTK inhibitor SAR442168 (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Belarus;Hong Kong;Estonia;Taiwan;Finland;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Italy;Czech Republic;Mexico;Canada;Poland;Romania;Denmark;Bulgaria;Germany;Japan;China;Sweden
69EUCTR2019-004972-20-HU05/08/202002/06/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Serbia;United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
70EUCTR2019-004980-36-GR31/07/202002/06/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3United States;Belarus;Portugal;Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Latvia;Kuwait;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2019-004980-36-SK31/07/202027/05/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Kuwait;Latvia;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
72EUCTR2020-000637-41-DE31/07/202017/06/2020RMS study of BTK inhibitor SAR442168 (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Belarus;Czechia;Taiwan;Estonia;Hong Kong;Finland;Spain;Ukraine;Turkey;Lithuania;Austria;Russian Federation;Italy;Mexico;Canada;Poland;Romania;Denmark;Bulgaria;Germany;China;Japan;Sweden
73EUCTR2019-004972-20-GB29/07/202011/05/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
INN or Proposed INN: TERIFLUNOMIDE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Serbia;United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
74NCT04338061July 2, 20206/4/2020Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and SafetyRelapsing Multiple SclerosisDrug: Evobrutinib;Drug: Placebo (match to Teriflunomide);Drug: Teriflunomide;Drug: Placebo (match to Evobrutinib)Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyEMD Serono Research & Development Institute, Inc.Recruiting18 Years55 YearsAll930Phase 3United States;Bulgaria;Germany;Greece;Italy;Lithuania;Poland;Puerto Rico;Slovakia;Spain;Ukraine
75EUCTR2017-003008-30-GB01/07/202017/05/2018Simvastatin in Secondary Progressive Multiple SclerosisA double-blind, randomised, placebo-controlled single-site study of high dose simvastatin treatment for secondary progressive multiple sclerosis: impact on vascular perfusion and oxidative damage - MS-OPT Version 1.3 dated 23/05/18 Multiple Sclerosis (Secondary Progressive)
MedDRA version: 20.0Level: HLTClassification code 10052785Term: Multiple sclerosis acute and progressiveSystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Simvastatin 40 mg film-coated tablets
Product Name: Simvastatin 40 mg film-coated tablets
Product Code: Not applicable
INN or Proposed INN: Simvastatin
University College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT04260711July 1, 202021/1/2020Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS).The Safety and Cost-effectiveness of Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS): a Randomized Rater-blinded Multicenter Trial.Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary ProgressiveDrug: DMTVU University Medical CenterNULLRecruiting18 YearsN/AAll130N/ANetherlands
77ChiCTR20000340982020-07-012020-06-23A New Quantitative Method Used to Evaluate Cervical Spinal Cord Damage in Multiple Sclerosis: Diffusional Kurtosis Imaging ResearchA New Quantitative Method Used to Evaluate Cervical Spinal Cord Damage in Multiple Sclerosis: Diffusional Kurtosis Imaging Research Multiple SclerosisGold Standard:Conventional cervical MRI;Index test:Diffusional Kurtosis Imaging;The First Hospital of Jilin UniversityNULLPendingBothTarget condition:48;Difficult condition:0China
78NCT04458688July 202030/6/2020Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple SclerosisInvestigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis: a Novel, Advanced Multimodal MRI and Optical Coherence Tomography-Angiography (OCTA) StudyMultiple Sclerosis, Relapsing-RemittingOther: Observation of Ocrelizumab as Treatment in RRMS PatientsWayne State UniversityNULLNot yet recruiting18 Years60 YearsAll80NULL
79NCT04410978June 30, 202028/5/2020Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor SAR442168A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple SclerosisRelapsing Multiple SclerosisDrug: SAR442168;Drug: Teriflunomide HMR1726;Drug: Placebo to match SAR442168;Drug: Placebo to match TeriflunomideSanofiNULLRecruiting18 Years55 YearsAll900Phase 3United States;Bulgaria;Canada;Czechia;Estonia;Spain
80NCT04480307June 17, 202010/7/2020Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple SclerosisA Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis (RMS)Multiple SclerosisDrug: temelimab 18 mg/kg;Drug: temelimab 36 mg/kg;Drug: temelimab 54 mg/kg;Drug: PlaceboGeNeuro Innovation SASNULLRecruiting18 Years55 YearsAll40Phase 2Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2019-001341-40-PT15/06/202031/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Austria;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
82NCT04338022June 12, 20206/4/2020Study of Evobrutinib in Participants With Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and SafetyRelapsing Multiple SclerosisDrug: Evobrutinib;Drug: Placebo (match to Teriflunomide);Drug: Teriflunomide;Drug: Placebo (match to Evobrutinib)Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyEMD Serono Research & Development Institute, Inc.Recruiting18 Years55 YearsAll930Phase 3United States;Australia;Belgium;Bulgaria;Canada;Estonia;France;Italy;Korea, Republic of;Poland;Spain;Taiwan;Germany
83EUCTR2019-001341-40-BG12/06/202007/05/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
84NCT04410991June 11, 202028/5/2020Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor SAR442168A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple SclerosisRelapsing Multiple SclerosisDrug: SAR442168;Drug: Teriflunomide HMR1726;Drug: Placebo to match SAR442168;Drug: Placebo to match TeriflunomideSanofiNULLRecruiting18 Years55 YearsAll900Phase 3United States;Belgium;Brazil;Canada;Chile;Czechia;Korea, Republic of;Latvia;Puerto Rico;Spain
85EUCTR2019-003352-37-NL11/06/202024/02/2020Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1Level: PTClassification code 10077875Term: Neuromyelitis optica spectrum disorderSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2019-001341-40-GR20/05/202010/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
87EUCTR2019-004822-15-SE18/05/202017/01/2020A Clinical Trial Examining the Effects of Temelimab Following Rituximab Treatment in Patients with Multiple SclerosisA Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients with Relapsing Forms of Multiple Sclerosis (RMS) - ProTEct-MS Multiple Sclerosis
MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Temelimab
Product Code: GNbAC1
INN or Proposed INN: temelimab
Product Name: Temelimab
Product Code: GNbAC1
INN or Proposed INN: temelimab
Product Name: Temelimab
Product Code: GNbAC1
INN or Proposed INN: temelimab
GeNeuro Innovation SASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Sweden
88EUCTR2019-003352-37-DE11/05/202006/01/2020Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1Level: PTClassification code 10077875Term: Neuromyelitis optica spectrum disorderSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of
89EUCTR2019-001341-40-CZ07/05/202011/02/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom
90EUCTR2018-000620-34-DE06/05/202008/11/2019Imatinib treatment for Multiple Sclerosis (MS) RelapsesImatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0Level: LLTClassification code 10028247Term: Multiple sclerosis like syndromeSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
INN or Proposed INN: IMATINIB MESILATE
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Department of Clinical Neuroscience, Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2019-001341-40-BE29/04/202017/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
92EUCTR2019-001341-40-HU29/04/202011/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
93EUCTR2019-001341-40-ES24/04/202007/05/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy - ARTIOS Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Farmacéutica S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
94EUCTR2019-002623-14-PL15/04/202021/01/2020A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosisA Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis Symptomatic relief of spasticity in Multiple Sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10028335Term: Muscle spasticitySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sativex
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
446Phase 3United States;Czech Republic;Poland;Romania;United Kingdom
95NCT04227470March 31, 202021/11/2019A Study of HBM9161 in NMOSD PatientsSafety, Tolerability, Pharmacodynamics and Efficacy of HBM9161 Weekly Subcutaneous Administration in Patients With Neuromyelitis Optica Spectrum Disorders (NMOSD) in ChinaNMO Spectrum DisorderDrug: HBM9161 InjectionHarbour BioMed (Guangzhou) Co. Ltd.NULLRecruiting18 YearsN/AAll12Phase 1China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2019-003352-37-AT27/03/202013/02/2020Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1Level: PTClassification code 10077875Term: Neuromyelitis optica spectrum disorderSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of
97EUCTR2017-001313-93-DE27/03/202012/02/2020A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple SclerosisAN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS Progressive multiple sclerosis (PMS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10053395Term: Progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United Arab Emirates;Morocco;Costa Rica;Spain;Lebanon;Ireland;Russian Federation;Colombia;Italy;France;Denmark;Netherlands;Bosnia and Herzegovina;Panama;Czechia;Guatemala;Egypt;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Germany;Algeria
98EUCTR2019-001549-42-GB27/03/202003/02/2020Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MSA multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis. - StarMS Highly active relapsing remitting multiple sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide monohydrate
INN or Proposed INN: Cyclophosphamide monohydrate
Product Name: Filgrastim
INN or Proposed INN: Filgrastim
Trade Name: Thymoglobuline
Product Name: Thymoglobuline
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
Trade Name: Alemtuzumab
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Product Name: Lenograstim
INN or Proposed INN: Lenograstim
Trade Name: Ocrelizumab
Product Name: Ocrelizumab
Sheffield Teaching HospitalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
198Phase 3United Kingdom
99EUCTR2016-001166-29-DE18/03/202012/08/2019A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST)A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST) - COAST relapsing-remitting multiple sclerosis
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Lemtrada
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab
Other descriptive name: ALEMTUZUMAB
Trade Name: Ocrevus
Product Name: ocrelizumab
INN or Proposed INN: ocrelizumab
Other descriptive name: OCRELIZUMAB
Product Name: autologous hematopoietic stem cells
Product Code: aHSC
University Medical Centre Hamburg-EppendorfNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Germany
100EUCTR2018-001511-73-DE17/03/202017/06/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary progressive multiple sclerosis (PPMS)
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Belarus;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2019-002623-14-CZ17/03/202019/12/2019A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosisA Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis Symptomatic relief of spasticity in Multiple Sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10028335Term: Muscle spasticitySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sativex Oromucosal Spray (non-marketed)
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
446Phase 3United States;Czech Republic;Poland;Romania;United Kingdom
102EUCTR2018-001511-73-IE16/03/202008/05/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary progressive multiple sclerosis (PPMS)
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
103EUCTR2019-002625-29-GB16/03/202018/06/2020A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple SclerosisA Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis - Study in MS patient Naïve to treatment with Nabiximols Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
MedDRA version: 20.0Level: PTClassification code 10028335Term: Muscle spasticitySystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sativex Oromucosal Spray
Product Name: Sativex Oromucosal Spray
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 3Poland;United Kingdom
104NCT04038541March 11, 20207/6/2019Prebiotic vs Probiotic in Multiple SclerosisPrebiotic and Probiotic Treatment Trial in Multiple SclerosisMultiple Sclerosis;Clinically Isolated Syndrome (CIS)Dietary Supplement: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac);Dietary Supplement: Probiotics (Visbiome®)Columbia UniversityNULLRecruiting18 YearsN/AAll20N/AUnited States
105EUCTR2018-003008-38-DE10/03/202006/05/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2016-002667-34-PL06/03/202014/11/2019A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple SclerosisAN OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF OCRELIZUMAB IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS Relapsing-remitting multiple sclerosis (MS)
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2United States;Poland;Italy
107EUCTR2018-001511-73-PT02/03/202030/04/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary progressive multiple sclerosis (PPMS)
MedDRA version: 20.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Belarus;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
108EUCTR2019-003352-37-ES25/02/202014/01/2020Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1 Level: PT Classification code 10077875 Term: Neuromyelitis optica spectrum disorder System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
55 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
109EUCTR2019-002623-14-GB24/02/202018/03/2020A study to evaluate the efficacy and safety of nabiximols oromucosal spray as add-on therapy in patients with muscle stiffness due to multiple sclerosisA Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis - Nabiximols Oromucosal Spray as Add-on Therapy in Patients with MS Symptomatic relief of spasticity in Multiple Sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10028335Term: Muscle spasticitySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: UK: Sativex Oromucosal Spray
Product Name: UK: Sativex Oromucosal Spray
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
446Phase 3United States;Czech Republic;Poland;Romania;United Kingdom
110NCT04242056February 20, 202021/1/2020To Study the Pathophysiological Features of Multiple SclerosisTo Study the Pathophysiological Features of Multiple Sclerosis: Combined Multi-modalities of Amyloid and Tau Images Associated With Serum Neurofilament Light Chain LevelsMultiple Sclerosis;Neurofilament Light Chain;Glial Fibrillary Acidic ProteinDrug: 18F-PM-PBB3Chang Gung Memorial HospitalNULLNot yet recruiting20 Years70 YearsAll38Phase 1/Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT04175834February 5, 202022/11/2019Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to OcrelizumabComparing the Risk and Severity of Infusion-Related Reactions in Patients Premedicated With Cetirizine Versus Diphenhydramine Prior to Ocrelizumab InfusionsMultiple Sclerosis;Infusion ReactionDrug: antihistamineProvidence Health & ServicesGenentech, Inc.Recruiting18 Years70 YearsAll52Phase 3United States
112NCT04291456January 31, 202018/11/2019Minocycline in MS: Confirmation of BenefitOpen-Label Trial of Minocycline in Early Multiple Sclerosis: Confirmation of Treatment BenefitMultiple Sclerosis;Clinically Isolated SyndromeDrug: Minocycline 100mgUniversity of CalgaryHotchkiss Brain Institute, University of CalgaryRecruiting18 Years60 YearsAll148Phase 3Canada
113NCT04140305January 16, 202024/10/2019Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)Multiple SclerosisDrug: RPC-1063CelgeneNULLRecruiting18 Years65 YearsAll250Phase 3United States;Canada;Puerto Rico
114EUCTR2019-003352-37-DK15/01/202019/12/2019Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1Level: PTClassification code 10077875Term: Neuromyelitis optica spectrum disorderSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
115EUCTR2019-002625-29-PL14/01/202021/11/2019A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple SclerosisA Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
MedDRA version: 20.0Level: PTClassification code 10028335Term: Muscle spasticitySystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sativex Oromucosal Spray
Product Name: Nabiximols - Sativex
INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS)
Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL
INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS)
Other descriptive name: CANNABIDIOL
GW Pharma LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 3Poland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2018-000001-23-CZ13/01/202016/08/2018Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosisA phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS Symptomatic relief of spasticity in patients with multiple sclerosis
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dronabinol 25 mg/ml, oral drops
Product Code: BX-1
INN or Proposed INN: Dronabinol
Other descriptive name: Dronabinol
Bionorica SENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
548Phase 3Hungary;Czech Republic;Spain
117EUCTR2018-004701-11-BG10/01/202009/01/2020Evobrutinib compared to Avonex in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with an Interferon Beta 1a (Avonex®), in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION MS1) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib 10mg
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Product Name: Evobrutinib 25mg
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Avonex
Product Name: Interferon beta 1-a
INN or Proposed INN: INTERFERON BETA-1A
Merck Healthcare KGaANULLNot RecruitingFemale: yes
Male: yes
950Phase 3Serbia;United States;Taiwan;Estonia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany
118EUCTR2018-004700-19-BG10/01/202008/01/2020Evobrutinib compared to Avonex in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with an Interferon Beta 1a (Avonex®), in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION MS2) Relapsing Multiple Sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib 10mg
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Product Name: Evobrutinib 25mg
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Avonex
Product Name: Interferon beta 1-a
INN or Proposed INN: INTERFERON BETA-1A
Merck Healthcare KGaANULLNot RecruitingFemale: yes
Male: yes
950Phase 3Belarus;United States;Portugal;Slovakia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;South Africa;Tunisia;Kuwait;Moldova, Republic of;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Romania;Bulgaria;Germany
119NCT04178980January 1, 202025/11/2019Role of Simvastatin in Relapsing-Remitting Multiple SclerosisDouble-blinded, Randomized Controlled Trial of Simvastatin Use As Adjuvant Therapy in Relapsing-Remitting Multiple SclerosisSimvastatin Multiple SclerosisDrug: Simvastatin in relapsing remitting multiple sclerosisAssiut UniversityNULLNot yet recruiting18 Years65 YearsAll60Phase 1NULL
120EUCTR2019-000069-19-HR24/12/201920/02/2020Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesSerbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2018-001511-73-GB23/12/201909/04/2019A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - ORATORIO HANDA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - ORATORIO HAND Trade Name: Ocrevus
Product Name: Ocrevus
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: no
1000Phase 3Portugal;Hungary;Poland;Spain;Ireland;Croatia;Bulgaria;Germany;United Kingdom
122EUCTR2019-002566-13-NL19/12/201929/10/2019Personalizing the treatment with natalizumab in patients with multiple sclerosisPersonalized extended interval dosing of natalizumab in relapsing remitting multiple sclerosis - NEXT-MS Relapsing remitting multiple sclerosis
MedDRA version: 20.1 Level: LLT Classification code 10070425 Term: Multiple sclerosis exacerbation System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Amsterdam University Medical CenterNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesNetherlands
123NCT04047628December 19, 20195/8/2019Best Available Therapy Versus Autologous Hematopoetic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)A Multicenter Randomized Controlled Trial of Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (ITN077AI)Relapsing Multiple Sclerosis;Relapsing Remitting Multiple Sclerosis;Secondary Progressive Multiple SclerosisProcedure: Autologous Hematopoietic Stem Cell Transplantation;Biological: Best Available Therapy (BAT)National Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);Blood and Marrow Transplant Clinical Trials Network;PPD;Rho Federal Systems Division, Inc.Recruiting18 Years55 YearsAll156Phase 3United States;United Kingdom
124EUCTR2019-001829-26-ES18/12/201906/11/2019 A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1 Level: LLT Classification code 10077879 Term: Neuromyelitis optica spectrum disorder relapse System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of
125EUCTR2018-001511-73-HU18/12/201908/11/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary progressive multiple sclerosis (PPMS)
MedDRA version: 21.1 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2018-001511-73-HR16/12/201917/01/2020A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary progressive multiple sclerosis (PPMS)
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
127EUCTR2018-000284-93-EE10/12/201902/10/2019A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeksA multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks Relapsing forms of Multiple Sclerosis (RMS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GA Depot
INN or Proposed INN: GLATIRAMER ACETATE
Mapi Pharma Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
960Phase 3United States;Serbia;Belarus;Estonia;Ukraine;Russian Federation;Israel;Montenegro;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Croatia;Romania;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
128EUCTR2018-003008-38-HR10/12/201917/01/2020A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
142 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany
129EUCTR2019-000069-19-AT20/11/201906/06/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck, S.L.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4United States;Portugal;Serbia;Estonia;Morocco;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
130EUCTR2018-004731-76-ES19/11/201912/04/2019Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosisLong-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis Relapsing multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
105 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT04130997November 18, 201916/10/2019An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple SclerosisTG1101-RMS303 is an Open-label, Single-arm Extension Study Designed to Evaluate Long-term Safety and Efficacy of Ublituximab in Subjects With Relapsing Multiple Sclerosis. Subjects Who Complete the 96-week, Double-blind Treatment Period o TG1101-RMS301 or TG1101-RMS302 Are Eligible for Participation in This Open Label Extension (OLE) Study.Relapsing Multiple Sclerosis (RMS)Biological: UblituximabTG Therapeutics, Inc.NULLEnrolling by invitation18 YearsN/AAll1000Phase 3United States;Belarus;Croatia;Georgia;Poland;Russian Federation;Serbia;Ukraine
132EUCTR2018-000284-93-BG15/11/201908/10/2019A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeksA multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks Relapsing forms of Multiple Sclerosis (RMS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GA Depot
INN or Proposed INN: GLATIRAMER ACETATE
Mapi Pharma Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
960Phase 3United States;Serbia;Belarus;Estonia;Ukraine;Russian Federation;Israel;Montenegro;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Croatia;Romania;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
133NCT04171310November 13, 201919/11/2019Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male SubjectsAn Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-SAR442168 (Not More Than 3.7 MBq) in Healthy Male SubjectsMultiple SclerosisDrug: SAR442168SanofiNULLCompleted30 Years65 YearsMale6Phase 1United Kingdom
134EUCTR2019-003001-94-SK06/11/201913/09/2019Use of GLP-1 analogs in the treatment of multiple sclerosisUse of GLP-1 analogs in the treatment of multiple sclerosis - MSGLP Our hypothesis is that patients with MS have a disorder of energy metabolism in neurons and glial cells of the CNS, contributing to the development and progression of demyelinating foci and neurodegeneration, and manifested by insulin resistance in both peripheral tissues and the CNS.
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere.
Product Name: Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere
Lekárska fakulta UK BratislavaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Slovakia
135NCT03910738October 29, 20191/4/2019TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple SclerosisTOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection;Drug: Placebo 4 mL Solution for Injection;Procedure: MRI;Behavioral: Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities;Behavioral: Assessment of disabilityUniversity Hospital, Strasbourg, FranceBayer;Fédération Hospitalo-Universitaire NEUROGENYCSRecruiting18 Years55 YearsMale40Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT03963375October 28, 201923/5/2019Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple SclerosisCladribine Tablets: Collaborative Study to Evaluate the Impact On Central Nervous System Biomarkers in Multiple SclerosisMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: CladribineWashington University School of MedicineEMD SeronoRecruiting18 Years65 YearsAll50Phase 4United States
137NCT04096443October 28, 20197/8/2019Oral FMT (Fecal Microbial Transplant) in Subjects With Multiple SclerosisA Pilot Study of Oral FMT (Fecal Microbial Transplant) in Subjects With Multiple SclerosisMultiple SclerosisBiological: Fecal microbial transplant (FMT)Griffin HospitalYale-Griffin Prevention Research Center;Multiple Sclerosis Treatment Center, Derby, ConnecticutRecruiting18 Years40 YearsAll15Early Phase 1United States
138JPRN-JapicCTI-20511915/10/201920/01/2020A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patientsA compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients neuromyelitis optica(NMO), neuromyelitis optica spectrum disorders (NMOSD)Intervention name : SA237
INN of the intervention : satralizumab
Dosage And administration of the intervention : 120 mg subcutaneously at Weeks 0, 2 and 4 and every 4 weeks thereafter
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Chugai Pharmaceutical Co., Ltd.F. Hoffmann-La Roche Ltdcomplete1274BOTH30NAJapan
139EUCTR2019-000069-19-PT14/10/201913/05/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4Romania;Serbia;United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
140NCT04129736October 10, 201915/10/2019Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple SclerosisDetermination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily.Multiple Sclerosis, PharmacokineticsDrug: Teriflunomide 14 MGJan LyckeNULLRecruiting18 Years65 YearsAll20Phase 4Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2018-001511-73-BG02/10/201919/06/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary progressive multiple sclerosis (PPMS)
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
142NCT04115488October 1, 201910/9/2019Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)Relapsing-Remitting Multiple Sclerosis (RRMS)Biological: Intravenous (IV) infusionsPolpharma Biologics S.A.NULLActive, not recruiting18 Years60 YearsAll260Phase 3Belarus;Croatia;Georgia;Moldova, Republic of;Poland;Serbia;Ukraine
143EUCTR2018-001511-73-PL30/09/201906/08/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary progressive multiple sclerosis (PPMS)
MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Belarus;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
144EUCTR2017-001362-25-NL30/09/201910/09/2019 Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS Relapsing remitting multiple sclerosis.
MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Helse Bergen HF, Haukeland University HospitalNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noDenmark;Netherlands
145NCT04121221September 19, 20198/10/2019A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMSA Phase III Study in Subjects With Relapsing Forms of Multiple Sclerosis (RMS) to Asses Efficacy, Safety and Tolerability of GA Depot, a Long Acting IM Injection of Glatiramer Acetate, Once Monthly Compared to PlaceboMultiple Sclerosis, Relapsing-RemittingDrug: GA Depot;Other: PlaceboMapi Pharma Ltd.NULLRecruiting18 Years55 YearsAll960Phase 3United States;Bulgaria;Estonia;Georgia;Moldova, Republic of;Russian Federation;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2018-004751-20-HR18/09/201902/12/2019A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple SclerosisAntelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PB006
INN or Proposed INN: NATALIZUMAB
Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Polpharma Biologics S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of
147NCT04002934September 10, 201925/6/2019Bazedoxifene Acetate as a Remyelinating Agent in Multiple SclerosisA Phase II Randomized, Double-Blind, Parallel-Group, Placebo Controlled Delayed-Start Trial to Assess the Efficacy, Safety, and Tolerability of Bazedoxifene Acetate (BZA) as a Remyelinating Agent in Patients With Multiple SclerosisMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Bazedoxifene AcetateRiley Bove, MDNULLRecruiting40 Years65 YearsFemale50Phase 2United States
148NCT04032171September 10, 201923/7/2019Study of Evobrutinib in Participants With Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and SafetyRelapsing-remitting Multiple SclerosisDrug: Evobrutinib;Drug: Avonex®;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years55 YearsAll1Phase 3United States;Germany
149EUCTR2019-000069-19-PL08/09/201927/06/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4Lithuania;United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
150EUCTR2019-000069-19-BG05/09/201904/06/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2019-000169-19-GB03/09/201905/06/2019Clinical trial to determine the effect of Famciclovir on Epstein Barr virus levels in the saliva of patients with Multiple Sclerosis.Clinical trial to determine the effect of Famciclovir on Epstein-Barr virus activity as measured by EBV shedding in saliva of patients with Multiple Sclerosis. - Famciclovir in Multiple Sclerosis Epstein Barr virus infection in people with multiple sclerosis.
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: LLTClassification code 10014077Term: EBV infectionSystem Organ Class: 100000004862;Therapeutic area: Diseases [C] - Virus Diseases [C02]
Trade Name: Famciclovir
Product Name: Famciclovir
INN or Proposed INN: Famciclovir
Other descriptive name: 2-(2-(2-Amino-9H-purin-9-yl)ethyl)-1,3-propanediol diacetate ester
Queen Mary University LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United Kingdom
152EUCTR2018-003008-38-PT02/09/201902/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Kuwait;Germany
153EUCTR2019-001960-31-FI27/08/201911/07/2019Effect of cladribine treatment on microglial activation in the CNSEffect of cladribine treatment on microglial activation in the CNS Multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Turku PET centreNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesFinland
154EUCTR2019-000069-19-LT27/08/201910/06/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
155NCT04032158August 26, 201923/7/2019Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and SafetyRelapsing-remitting Multiple SclerosisDrug: Evobrutinib;Drug: Avonex®;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years55 YearsAll3Phase 3United States;Germany;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Georgia;Hungary;Israel;Italy;Korea, Republic of;Mexico;Montenegro;Poland;Russian Federation;Serbia;Spain;Taiwan;Ukraine;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2019-000069-19-ES23/08/201904/07/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesSerbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
157EUCTR2018-001511-73-ES21/08/201904/07/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary progressive multiple sclerosis (PPMS)
MedDRA version: 20.1 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand
158EUCTR2019-000069-19-SE14/08/201910/05/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
159JPRN-JapicCTI-19483831/7/201902/07/2019Investigation for immune response against JC virus in Multiple Sclerosis patients on treatment with fingolimodA 18-month, multicenter, two-cohort, prospective, observational study to investigate immune response against JC virus in Multiple Sclerosis patients on treatment with 0.5 mg fingolimod (FTY720) Multiple SclerosisIntervention name : Gilenya / Imusera
INN of the intervention : Fingolimod
Dosage And administration of the intervention : 0.5mg/day Fingolimod orally
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Novartis Pharma K.K.Mitsubishi Tanabe Pharma Corporationrecruiting18BOTH280NAJapan
160EUCTR2018-004557-24-DE29/07/201918/06/2019Clarifying the mechanism of action of cladribine in relapsing multiple sclerosisClarifying the mechanism of action of cladribine in relapsing multiple sclerosis - ClaiMS, Cladribine in MS Multiple Sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Westfälische Wilhelms-Universität Münster c/o Universitätsklinikum Münster, Geschäftsbereich Recht u. DrittmittelNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesGermany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2019-001505-24-NO25/07/201928/05/2019A Clinical Study Comparing Rituximab and Cladribine for Relapsing Multiple SclerosisNorwegian study of Oral cladribine versus Rituximab in Multiple Sclerosis (NOR-MS). A prospective randomized open-label blinded endpoint (PROBE) multicenter non-inferiority study. - NOR-MS Relapsing Multiple Sclerosis (RMS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0 Level: PT Classification code 10080700 Term: Relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Department of Neurology, Division of Clinical Neuroscience, Oslo University HospitalNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
264 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noNorway
162EUCTR2018-004751-20-PL22/07/201925/04/2019A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple SclerosisAntelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PB006
INN or Proposed INN: NATALIZUMAB
Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Polpharma Biologics S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of
163NCT03933202July 22, 201929/4/2019A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS)Cladribine Tablets: Observational Evaluation of Effectiveness and Patient-Reported Outcomes (PROs) in Suboptimally Controlled Patients Previously Taking Oral or Infusion Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) (MASTER-2)Multiple SclerosisDrug: Cladribine TabletsEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyRecruiting18 YearsN/AAll250United States
164EUCTR2018-003008-38-BE17/07/201919/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Serbia;Portugal;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
165EUCTR2018-004731-76-CZ12/07/201925/02/2019Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosisLong-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis Relapsing multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 2France;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2019-000069-19-CZ12/07/201907/05/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4United States;Portugal;Serbia;Estonia;Morocco;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
167EUCTR2018-003008-38-BG10/07/201905/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a, 30 µg/0.5 ml
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a, 30 µg/0.5 ml
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Serbia;Portugal;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
168EUCTR2018-000516-22-PT08/07/201927/11/2018Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric ParticipantsA Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacyand Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TECFIDERA
Product Name: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
340Phase 3United States;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Greece;Thailand;Turkey;Israel;Russian Federation;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of
169NCT04022473July 7, 201915/7/2019Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy VolunteersA Randomized, Double-Blind Study to Compare Gastrointestinal Tolerability Following Oral Administration of Bafiertam™ (Monomethyl Fumarate) or Tecfidera® (Dimethyl Fumarate) to Healthy Male and Female VolunteersMultiple SclerosisDrug: Bafiertam;Drug: TecfideraBanner Life Sciences LLCNULLCompleted18 Years65 YearsAll210Phase 1United States
170NCT03983252July 201931/5/2019Effect of Alemtuzumab on Microglial Activation Positron Emission Tomography (PET) in Multiple SclerosisEffect of Alemtuzumab on Microglial Activation Assessed Using Novel [F-18]-Based Positron Emission Tomography (PET) Ligand in Multiple SclerosisMultiple SclerosisDrug: [F-18]PBR06Brigham and Women's HospitalGenzyme, a Sanofi CompanyNot yet recruiting18 Years60 YearsAll10Phase 1/Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2018-003008-38-GR27/06/201903/05/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
172NCT03656627June 27, 201931/8/2018Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseSafety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseAutoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative ColitisDrug: NivolumabAlliance Foundation Trials, LLC.Bristol-Myers SquibbRecruiting18 YearsN/AAll72Phase 1United States
173EUCTR2018-003008-38-SK24/06/201926/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3Serbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany
174NCT03774407June 20, 20195/12/2018Vaginal Estriol in Multiple SclerosisDual Benefits of Vaginal Estriol: Improved Urogenital Health and Re-myelination in Relapsing Remitting Multiple Sclerosis (RRMS)Multiple Sclerosis;Neurogenic BladderDrug: vaginal estriolTexas Tech University Health Sciences CenterNULLCompleted40 Years65 YearsFemale21Phase 2/Phase 3United States
175EUCTR2017-004703-51-GB18/06/201915/10/2018 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2019-000069-19-EE17/06/201922/05/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesSerbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
177EUCTR2017-004703-51-BE17/06/201915/01/2019Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden
178NCT03995810June 15, 201918/6/2019Oral Carnosine for Neuromuscular Performance in Multiple SclerosisOral Carnosine for Neuromuscular Performance, Brain Biomarkers of Carnosine Metabolism and Health-related Quality of Life in Multiple SclerosisMultiple SclerosisDietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeksUniversity of Novi Sad, Faculty of Sport and Physical EducationCarnoMedCompleted18 Years65 YearsAll3N/ASerbia
179NCT03887065June 15, 201910/3/2019Magnetic Resonance Imaging Study of JM-4 in Multiple Sclerosis/Clinically PatientsMagnetic Resonance Imaging 12 Day Study for Multiple Sclerosis/Clinically Isolated Syndrome Trial of JM-4 Novel Human PeptideMultiple SclerosisDrug: JM-4Cook, Stuart, MDNULLNot yet recruiting18 Years55 YearsAll15Early Phase 1NULL
180EUCTR2018-004731-76-NL11/06/201915/04/2019Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosisLong-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis Relapsing multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
105 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT04056897June 7, 201912/8/2019Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple SclerosisInternational Multicenter, Randomized, Double-blind, Double-masked, Placebo-controlled Study of the Efficacy and Safety of BCD-132 Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple SclerosisMultiple SclerosisBiological: BCD-132, 125 mg;Drug: Teriflunomide;Drug: Placebo;Biological: BCD-132, 500 mgBiocadNULLRecruiting18 Years60 YearsAll270Phase 2Russian Federation
182NCT04203017June 1, 201930/10/2019Fecal Microbiota Transplantation After Autologous HSCT in Patients With Multiple SclerosisAllogeneic Fecal Microbiota Transplantation as a Consolidation Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple SclerosisMultiple SclerosisBiological: allogeneic fecal microbiotaSt. Petersburg State Pavlov Medical UniversityNULLRecruiting18 Years55 YearsAll20Phase 1Russian Federation
183EUCTR2018-003008-38-HU30/05/201908/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
142 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Germany;Tunisia
184EUCTR2018-003927-12-NL24/05/201923/01/2019Dose-finding study for SAR442168 in relapsing multiple sclerosisA Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis Relapsing Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;France;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden
185NCT03933215May 21, 201929/4/2019A Study of Suboptimally Controlled Participants Previously Taking Injectable Disease-modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS)Cladribine Tablets: Observational Evaluation of Effectiveness and Patient-Reported Outcomes (PROs) in Suboptimally Controlled Patients Previously Taking Injectable Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) (CLICK-MS)Multiple SclerosisDrug: Cladribine TabletsEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyRecruiting18 YearsN/AAll136United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT03896217May 16, 201926/10/2018Simvastatin in Secondary Progressive Multiple SclerosisA Double-blind, Randomised, Placebo-controlled Single-site Study of High Dose Simvastatin Treatment for Secondary Progressive Multiple Sclerosis: Impact on Vascular Perfusion and Oxidative DamageSecondary Progressive Multiple SclerosisDrug: SimvastatinUniversity College, LondonMS SocietyRecruiting18 Years65 YearsAll40Phase 2United Kingdom
187EUCTR2017-004703-51-HR06/05/201903/06/2019 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
188NCT03824938April 30, 20199/1/2019Aspirin for Exercise in Multiple Sclerosis (ASPIRE)Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS)Multiple SclerosisDrug: Aspirin 650mg Oral Capsule;Drug: Acetaminophen Tab 650mg;Other: PlaceboColumbia UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Recruiting18 Years65 YearsAll60Phase 1/Phase 2United States
189EUCTR2018-003927-12-ES26/04/201922/01/2019Dose-finding study for SAR442168 in relapsing multiple sclerosisA Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis Relapsing Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden
190EUCTR2017-004703-51-GR24/04/201927/03/2019 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2012-000541-12-HR23/04/201917/05/2019Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Portugal;Greece;Finland;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Australia;Denmark;Bulgaria;Germany
192EUCTR2018-004731-76-SK18/04/201925/02/2019Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosisLong-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 21.1Level: PTClassification code 10067063Term: Progressive relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
105Phase 2United States;France;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands
193NCT04408742April 15, 201926/5/2020Relationship Between Pain, Anxiety and Fatigue and Knee Position Sense, Balance and Dual Task Performance During Menstrual Cycle in Females With Multiple SclerosisThe Relationship Between Pain, Anxiety and Fatigue and Knee Position Sense, Balance and Dual Task Performance During Menstrual Cycle in Females With Multiple SclerosisMultiple Sclerosis;Menstrual Pain;Anxiety;Fatigue;Neurologic SymptomsOther: pain;Other: fatigue;Other: anxiety;Other: position sense;Other: balance;Other: dual task performanceAnkara Yildirim Beyazit UniversityNULLCompleted26 Years49 YearsFemale14Turkey
194NCT03816345April 4, 201924/1/2019Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant NeoplasmBiological: NivolumabNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll264Phase 1United States
195EUCTR2018-004731-76-EE04/04/201914/03/2019Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosisLong-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis Relapsing multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
105 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Czech Republic;Estonia;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2018-003008-38-ES02/04/201917/05/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
142 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Croatia;Bulgaria;Kuwait;Tunisia;Germany
197NCT03025269April 2, 201916/1/2017Ocrelizumab Effects on Physiological and Cognitive Changes in Multiple SclerosisEffect of Ocrelizumab on Gray Matter Pathology, Leptomeningeal Inflammation and Cognitive Dysfunction in Multiple SclerosisMultiple SclerosisDrug: OcrelizumabUniversity at BuffaloNULLEnrolling by invitation18 Years60 YearsAll30United States
198EUCTR2017-004703-51-NL29/03/201916/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden
199NCT03889639March 29, 20191/3/2019Dose-finding Study for SAR442168 in Relapsing Multiple SclerosisA Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: SAR442168;Drug: Placebo;Drug: Locally approved intravenous contrast medium for contrast enhanced MRISanofiNULLCompleted18 Years55 YearsAll128Phase 2United States;Canada;Czechia;Estonia;France;Netherlands;Russian Federation;Slovakia;Spain;Ukraine;Sweden
200EUCTR2017-004703-51-LV28/03/201924/01/2019 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201NCT03283397March 26, 201912/9/2017A Phase IIIb, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of EK-12 in Patients With RRMSA Phase IIIb, Multi-center, International, Randomized, Assessor-blind, Active-controlled Parallel Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Neuropeptide Combination of Metenkefalin and Tridecactide (EK-12) in Comparison to Interferon Beta-1a (REBIF®) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)Multiple Sclerosis, Relapsing-RemittingDrug: EK-12;Drug: INF beta-1aBosnalijek D.DMonitorCRORecruiting18 Years55 YearsAll400Phase 3Turkey
202NCT04286828March 25, 201923/2/2020Position Sense, Balance, and Dual Task Performance at the Menstrual Cycle in Females With Multiple SclerosisAn Investigation of Knee Position Sense, Balance, and Dual Task Performance in Different Phases of Menstrual Cycle in Females With Multiple SclerosisMultiple Sclerosis;Neurologic Symptoms;Menstrual CycleOther: Position Sense;Other: Balance;Other: Dual Task PerformanceAnkara Yildirim Beyazit UniversityNULLCompleted26 Years49 YearsFemale27Turkey
203NCT03945006March 25, 20198/5/2019Balance, Trunk Impairment and Fear of Falling in Multiple Sclerosis Patients With IncontinenceAn Investigation of Balance, Trunk Impairment, and Fear of Falling in Multiple Sclerosis Patients With IncontinenceMultiple Sclerosis;Physical Therapy;IncontinenceOther: Incontinence Severity;Other: Balance;Other: Trunk impairment;Other: Fear of fallingAnkara Yildirim Beyazit UniversityNULLCompleted24 Years58 YearsAll36Turkey
204EUCTR2018-002145-11-GB21/03/201911/10/2018A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab AdministrationA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration - BIIB 101MS329 Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI
Product Name: TYSABRI
INN or Proposed INN: NATALIZUMAB
Trade Name: TYSABRI
Product Name: TYSABRI
INN or Proposed INN: NATALIZUMAB
Other descriptive name: BG00002
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom
205EUCTR2018-003927-12-SK18/03/201923/01/2019Dose-finding study for SAR442168 in relapsing multiple sclerosisA Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis Relapsing Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10067063 Term: Progressive relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206EUCTR2017-004703-51-PT18/03/201924/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
207EUCTR2018-002145-11-NL14/03/201905/11/2018A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab AdministrationA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: BG00002
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;France;Canada;Spain;Belgium;Australia;Israel;Germany;Netherlands;United Kingdom;New Zealand;Italy
208EUCTR2018-003927-12-EE11/03/201928/01/2019Dose-finding study for SAR442168 in relapsing multiple sclerosisA Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis Relapsing Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Czech Republic;Estonia;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden
209EUCTR2018-002145-11-FR08/03/201931/10/2018 A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID TreatmentA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - NOVA Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
480 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;France;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;Italy;United Kingdom
210EUCTR2018-003927-12-SE06/03/201911/01/2019Dose-finding study for SAR442168 in relapsing multiple sclerosisA Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis Relapsing Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2018-000516-22-HU04/03/201902/01/2019Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric ParticipantsA Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
340 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of
212NCT03808142February 20, 201910/1/2019PROmyBETAappGame: a Study to Learn More About the Medication Usage & Patient Reported Outcomes Via the myBETAapp and to Find Out More About the Usage of Game Principles and Game Design Elements (Gamification) in Medical Care of Patients With Multiple Sclerosis Treated With BetaferonPROmyBETAappGame: Ascertaining Medication Usage & Patient Reported Outcomes Via the myBETAapp and Exploring Gamification in Patients With Multiple Sclerosis Treated With BetaferonMultiple SclerosisOther: myBETAapp;Other: PEAK;Drug: Betaferon, BAY 86-5046;Device: BETACONNECTBayerNULLCompleted18 YearsN/AAll79Germany
213EUCTR2017-004703-51-LT19/02/201903/12/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
214EUCTR2017-001294-16-DE18/02/201907/11/2018A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl FumarateA Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate Relapsing-Remitting Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Alkermes, Inc.NULLNot Recruiting Female: yes
Male: yes
500 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Poland;Germany
215EUCTR2018-002145-11-DE15/02/201917/10/2018A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab AdministrationA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: BG00002
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;New Zealand;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT03752307February 15, 201915/11/2018Safety and Tolerability of ISX (Isoxsuprine HCL) in MS RelapsesDouble-blind, Placebo-controlled, Randomized Study of the Safety and Tolerability of Isoxsuprine HCL Combined With High Dose Steroid Treatment of Multiple Sclerosis (MS) RelapseMultiple SclerosisDrug: Isoxsuprine Hydrochloride;Drug: Placebo;Drug: CorticosteroidUniversity of New MexicoNULLRecruiting18 Years50 YearsAll20Phase 1/Phase 2United States
217NCT03623243February 14, 20197/8/2018Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients.Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb StudyMultiple Sclerosis, Relapsing MS, Advancing Multiple SclerosisDrug: SiponimodNovartis PharmaceuticalsNULLRecruiting18 Years65 YearsAll400Phase 3United States;Puerto Rico
218EUCTR2017-004703-51-ES31/01/201925/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Farmacéutica, S.ANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
219EUCTR2017-004702-17-PL25/01/201917/10/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
220NCT03653273January 24, 201928/8/2018Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP)Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 YearsMultiple SclerosisOther: DMT withdrawal;Drug: DMT continuationRennes University HospitalNULLRecruiting50 YearsN/AAll250Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2017-004703-51-FR18/01/201922/10/2018 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
222EUCTR2017-004703-51-DK18/01/201911/12/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
223NCT04086225January 17, 20199/9/2019Effects of Cladribine Tablets on the Pharmacokinetics of Microgynon®A Randomized, Double-blind, 2-Period, 2-Sequence Crossover Phase I Study With a 1 Month run-in Period to Examine the Effect of Cladribine Tablets on the Pharmacokinetics of a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel (Microgynon®) in Pre-Menopausal Women With Relapsing Multiple Sclerosis (RMS).Relapsing Multiple Sclerosis (RMS)Drug: Cladribine;Drug: Placebo;Drug: Microgynon®Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, GermanyNULLRecruiting18 Years45 YearsFemale34Phase 1Germany;Poland
224NCT03745144January 17, 201914/11/2018Effects of Cladribine Tablets on the Pharmacokinetics of Microgynon®A Randomized, Double-blind, 2-Period, 2-Sequence Crossover Phase I Study With a 1 Month run-in Period to Examine the Effect of Cladribine Tablets on the Pharmacokinetics of a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel (Microgynon®) in Pre-Menopausal Women With Relapsing Multiple Sclerosis (RMS).Relapsing Multiple Sclerosis (RMS)Drug: Cladribine;Drug: Placebo;Drug: Microgynon®Merck KGaA, Darmstadt, GermanyNULLRecruiting18 Years45 YearsFemale34Phase 1Germany;Poland
225EUCTR2018-000516-22-EE14/01/201917/12/2018Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3- Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
340 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;Portugal;United States;Saudi Arabia;Estonia;Taiwan;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226EUCTR2017-004886-29-IE11/01/201909/05/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noEstonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
227EUCTR2017-004703-51-DE10/01/201927/09/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
228NCT03803800January 9, 20199/1/2019Periodized Rehabilitation and Beta-alanine Supplementation in Multiple SclerosisPeriodized Rehabilitation and Beta-alanine Supplementation in Multiple SclerosisMultiple SclerosisOther: Classic, progressive endurance training;Other: Periodized exercise training;Dietary Supplement: beta-alanineHasselt UniversityNULLCompleted18 Years75 YearsAll31N/ABelgium
229EUCTR2017-004703-51-FI02/01/201911/12/2018 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
230EUCTR2018-002145-11-ES02/01/201905/11/2018A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID TreatmentA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
480 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231NCT04106830January 1, 201925/9/2019Clinical and Imaging Patterns of Neuroinflammation Diseases in China (CLUE)Prospective Cohort Study of Clinical and Imaging Patterns of Neuroinflammation Diseases (CLUE)NMO Spectrum Disorder;MRI;Multiple SclerosisDrug: Intravenous steroidBeijing Tiantan HospitalNULLRecruiting16 Years80 YearsAll1000China
232NCT03650114December 28, 201817/8/2018Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MSAn Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisBiological: Ofatumumab;Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap);Biological: 13-valent pneumococcal conjugate vaccine (13-PCV);Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV);Biological: Seasonal Quadrivalent influenza vaccine;Biological: Keyhole limpet hemocyanin (KLH) neo-antigenNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll2010Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;India;Israel;Japan;Latvia;Lithuania;Mexico;Netherlands;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom
233NCT03689972December 26, 201827/9/2018A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab AdministrationA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab AdministrationMultiple Sclerosis, Relapsing-RemittingDrug: NatalizumabBiogenNULLActive, not recruiting18 Years60 YearsAll500Phase 3United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;United Kingdom
234EUCTR2017-004703-51-SE17/12/201815/11/2018 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
235EUCTR2018-001896-19-BG17/12/201811/10/2018Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS)Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) - EMPhASIS relapsing-remitting multiple sclerosis
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: VIDOFLUDIMUS CALCIUM
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Product Name: VIDOFLUDIMUS CALCIUM
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195Phase 2Poland;Ukraine;Romania;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236EUCTR2017-004702-17-ES12/12/201817/09/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Farmacéutica, S.A.NULLNot Recruiting Female: yes
Male: yes
284 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Estonia;Czech Republic;Poland;Spain;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
237EUCTR2018-002315-98-DK06/12/201809/07/2018The effect of cannabis products on nerve pain and muscle stiffness in patients with multiple sclerosis and in patients with spinal cord injury.The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial - The effect of medical cannabis on neuropathic pain and spasticity in patients with MS and SCI Central neuropathic pain and spasticity
MedDRA version: 20.0Level: PTClassification code 10028335Term: Muscle spasticitySystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: LLTClassification code 10077975Term: Central neuropathic painSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cannabidiol capsule 5 mg
Product Code: N/A
INN or Proposed INN: Cannabidiol
Other descriptive name: CBD
Product Name: Dronabinol capsule 2,5 mg
Product Code: N/A
INN or Proposed INN: DRONABINOL
Other descriptive name: THC
Product Name: Cannabidiol / Dronabinol capsule 5 mg+2,5 mg
Product Code: N/A
INN or Proposed INN: DRONABINOL
Other descriptive name: THC
INN or Proposed INN: Cannabidiol
Other descriptive name: CBD
Aarhus UniversitetshospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
448Phase 2Denmark
238EUCTR2017-004702-17-BG03/12/201823/10/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
239NCT03944447December 1, 20183/5/2019Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;CoronavirusDrug: Cannabis, MedicalOMNI Medical Services, LLCOMNI Medical Services IncRecruiting7 YearsN/AAll200000Phase 2United States
240EUCTR2017-004703-51-HU29/11/201811/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241EUCTR2017-004703-51-AT28/11/201817/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden
242EUCTR2017-004703-51-SK21/11/201828/09/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
243NCT03594487November 16, 20187/6/2018Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple SclerosisFecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis: A Phase 1b Clinical Trial to Evaluate Feasibility, Safety, Tolerability and Effects on Immune FunctionRelapsing Remitting Multiple SclerosisDrug: FMP30 Donor Stool;Procedure: Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool;Other: Observational ControlUniversity of California, San FranciscoNULLRecruiting18 Years60 YearsAll30Phase 1United States
244NCT03621761November 15, 20183/8/2018Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis FatigueA Randomized Controlled Trial of Telephone-delivered Cognitive Behavioral-therapy, Modafinil, and Combination Therapy of Both Interventions for Fatigue in Multiple SclerosisMultiple SclerosisBehavioral: Telephone-based Cognitive Behavioral Therapy;Drug: ModafinilUniversity of MichiganUniversity of Washington;Patient-Centered Outcomes Research Institute;National Multiple Sclerosis SocietyRecruiting18 YearsN/AAll330Phase 4United States
245NCT04120675November 9, 201824/9/2019Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple SclerosisRandomized, Double Blind, Controlled Prospective Study, to Evaluate the Therapeutic Effects of Early Harvest Olive Oil in Cognitive Functions of Patients With Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis.Progressive Multiple SclerosisDietary Supplement: Freshly-Pressed Extra Virgin Olive OilAristotle University Of ThessalonikiGreek Alzheimer's Association and Related Disorders;Yanni's Olive GroveRecruiting18 Years65 YearsAll150N/AGreece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246EUCTR2017-004702-17-IT07/11/201804/11/2020A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients - ND Multiple sclerosis
MedDRA version: 21.0Level: LLTClassification code 10028053Term: MSSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE
Product Name: Formistin 10 mg
Product Code: [Formistin 10 mg]
Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE
Product Name: Tachipirina
Product Code: [Tachipirina CPR 500mg]
Other descriptive name: paracetamolo 500 mg
Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML
Product Name: Solumedrol IM 125mg/2ml
Product Code: [Metilprednisolone]
Other descriptive name: Metilprednisolone sodio succinato
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: Ofatumumab
Other descriptive name: Ofatumumab
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: Ofatumumab
Other descriptive name: OFATUMUMAB
NOVARTIS PHARMA AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Czechia;Estonia;Spain;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Poland;Bulgaria;Germany;Latvia
247EUCTR2018-000001-23-ES06/11/201823/08/2018Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosisA phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS Symptomatic relief of spasticity in patients with multiple sclerosis
MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dronabinol
Product Code: BX-1
INN or Proposed INN: Dronabinol
Other descriptive name: Dronabinol
Bionorica SENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
548Phase 3Hungary;Spain
248EUCTR2017-004702-17-LV02/11/201803/09/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Germany;Latvia;Italy
249EUCTR2017-004702-17-LT31/10/201817/09/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
250EUCTR2018-000001-23-HU25/10/201816/08/2018Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosisA phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS Symptomatic relief of spasticity in patients with multiple sclerosis
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]
Bionorica SENULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
548 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noCzech Republic;Hungary;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251EUCTR2017-004702-17-CZ23/10/201816/08/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
252EUCTR2018-003231-30-ES19/10/201817/09/2018EFFECTIVENESS OF REPEATED INJECTIONS OF BOTULINUM TOXIN IN THE GAIT AND QUALITY OF LIFE OF ADULT PATIENTS WITH WEAKNESS AND MUSCLE RIGIDITY DUE TO MULTIPLE ESCLEROSISEFFECTIVENESS OF THE REPEATED INFILTRATIONS OF BOTULINUM TOXIN A IN THE GAIT AND QUALITY OF LIFE IN ADULTS WITH SPASTIC PARAPARESIA SECONDARY TO MULTIPLE SCLEROSIS - BOTULINUM TOXIN IN PATIENTS WITH SPASTIC PARAPARESIA ASSOCIATED WITH ESCLEROSIS MULTIPLE Multiple sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Dysport
INN or Proposed INN: BOTULINUM TOXIN TYPE A
Other descriptive name: BOTULINUM TOXIN TYPE A
Aránzazu Vázquez DoceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 3Spain
253NCT03740295October 5, 20185/10/2018Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple SclerosisImpact of Ketone Bodies and Epigallocatechin Gallate in Multiple SclerosisMultiple SclerosisDietary Supplement: Coconut oil and epigallocatechin gallate;Other: PlaceboFundación Universidad Católica de Valencia San Vicente MártirValencian Institute of Neurorehabilitation FoundationCompleted19 Years65 YearsAll60Phase 2Spain
254NCT03674099October 1, 201814/9/2018Imatinib for Multiple Sclerosis (MS) RelapsesImatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised StudyMultiple SclerosisDrug: Imatinib Mesylate;Drug: MethylprednisoloneTomas OlssonThe Swedish Research CouncilRecruiting18 Years55 YearsAll200Phase 2Denmark;Germany;Norway;Sweden
255EUCTR2017-004702-17-EE17/09/201828/08/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Czech Republic;Estonia;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256NCT03166800September 15, 201823/5/2017MitoQ for Fatigue in Multiple SclerosisMitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled TrialMultiple Sclerosis;FatigueDrug: MitoquinoneOregon Health and Science UniversityMitoQ LtdCompleted18 Years70 YearsAll9Phase 1/Phase 2United States
257NCT03606460September 14, 201823/7/2018A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)A Phase IIIb, Open-Label Study To Evaluate The Safety And Tolerability Of Shorter Infusions Of Ocrelizumab In Patients With Primary Progressive And Relapsing Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab Dose 1;Drug: Ocrelizumab Dose 2 and Dose 3Genentech, Inc.NULLCompleted18 Years55 YearsAll141Phase 3United States
258NCT03560739September 11, 201815/5/2018A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS PatientsA 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS PatientsMultiple SclerosisCombination Product: ofatumumab with PRF;Combination Product: ofatumumab with AINovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll284Phase 2United States;Austria;Bulgaria;Czechia;Estonia;Latvia;Lithuania;Russian Federation;Spain
259EUCTR2017-004158-40-FR11/09/201804/07/2018NAA Prospective study evaluating the effect of ocrelizumab on brain innate immune Microglial cells Activation in Multiple Sclerosis using PET-MRI with 18F-DPA714 - INN-MS Patients with Relapsing MS or primary progressive MS
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
71 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance
260EUCTR2017-004886-29-NL05/09/201827/06/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261EUCTR2017-004702-17-AT01/09/201810/08/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
262EUCTR2014-000253-36-NL30/08/201816/04/2018A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisordersA Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
MedDRA version: 20.0Level: LLTClassification code 10029322Term: Neuromyelitis opticaSystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: MEDI-551
Product Code: MEDI-551
INN or Proposed INN: Inebilizumab
MedImmune LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 2;Phase 3Serbia;United States;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;India;Peru;Australia;South Africa;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;New Zealand;Japan
263NCT03605238August 15, 201829/6/2018Treatment of Relapsed and/or Refractory AQP4-IgG Seropositive NMOSD by Tandem CAR T Cells Targeting CD19 and CD20Clinical Study of CD19/CD20 tanCAR T Cells in Relapsed and/or Refractory AQP4-IgG Seropositive Neuromyelitis Optica Spectrum Disorders (NMOSD)Neuromyelitis Optica Spectrum DisorderBiological: Corticosteroids & tanCART19/20Chinese PLA General HospitalNULLWithdrawn12 Years75 YearsAll0Phase 1China
264NCT03500289August 10, 20184/4/2018Ketamine for Treatment of MS FatigueKetamine for Treatment of Multiple Sclerosis-related FatigueMultiple Sclerosis;FatigueDrug: Ketamine;Drug: MidazolamJohns Hopkins UniversityNational Multiple Sclerosis SocietyCompleted18 Years65 YearsAll18Phase 1/Phase 2United States
265EUCTR2017-004886-29-CZ08/08/201810/05/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noEstonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT03589105August 6, 20185/7/2018A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic SettingAn Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab 300 mg;Drug: Ocrelizumab 600 mgHoffmann-La RocheNULLActive, not recruiting18 YearsN/AAll423Phase 4France
267NCT04450030August 1, 201824/6/2020Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple SclerosisImmunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis - Assessment of Mechanism of ActionMultiple Sclerosis, Relapsing-RemittingDrug: Methyl Prednisolonate;Procedure: ImmunoadsorptionUniversity Hospital MuensterNULLActive, not recruiting18 Years65 YearsAll204Germany
268EUCTR2018-001292-21-FR27/07/201805/06/2018Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 yearsDisease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years Secondary Progressive Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
CHU de RennesNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance
269EUCTR2016-004719-10-FI25/07/201812/06/2018A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PO
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
270EUCTR2017-002632-17-GB25/07/201806/02/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Norway;Netherlands;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271EUCTR2017-004886-29-SE23/07/201805/06/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1224Phase 3Estonia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
272EUCTR2017-002632-17-PT16/07/201819/04/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
273EUCTR2017-002632-17-AT11/07/201805/01/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
445 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesPortugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
274EUCTR2017-001313-93-CZ09/07/201826/03/2018A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple SclerosisAN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS Progressive multiple sclerosis (PMS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
900 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPanama;United Arab Emirates;Morocco;Spain;Costa Rica;Guatemala;Lebanon;Ireland;Russian Federation;Colombia;Italy;Egypt;France;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Denmark;Netherlands;Germany;Algeria;Bosnia and Herzegovina
275EUCTR2017-004886-29-FR05/07/201817/05/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noEstonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276EUCTR2018-000721-31-SE04/07/201824/04/2018A clincial study comparing the effectiveness of two doses of the drug Rituximab during long-term treatment of the neurological disease Multiple Sclerosis.RItuximab Long-Term DOSE Trial in Multiple Sclerosis – RIDOSE-MSA randomized trial of long-term dosage of rituximab in multiple sclerosisThe RIDOSE-MS trial is a multi-centre trial of long-term treatment with rituximab in MS, randomised between two different dosing regimens. Population: Patients with RRMS that has completed the RIFUND-MS trial in either the rituximab or DMF arm. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.Intervention: Treatment with rituximab (Mabthera®) 500 mg every six months. Both the previous rituximab and DMF arms from the RIFUND trial will be treated with rituximab in the RIDOSE trial.Control: After one year of treatment in RIDOSE-MS, patients will be randomised 1:1 to either continue with 500 mg every 6 months or 500 mg every 12 months and continue on this treatment schedule for another 3 years.Outcome: Primary outcome will be the proportion of patients remaining with no evidence of disease activity (NEDA) -3 over the randomised period of 3 years. As secondary endpoints progression of disability, brain atrophy, cognitive function and level of serum Neurofilament-Light will be evaluated. In addition, Patient-related outcome scales measuring fatigue, work ability and treatment satisfaction will be analysed. - RIDOSE-MS Patients with multiple sclerosis (MS), 20 - 52 years of age, that have completed the RIFUND-MS trial (EudraCT 2015-004116-38) will be offered to continue in this extension trial, RODOSE-MS. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB
Department of Clinical Sciences, Karolinska Institutet Danderyd HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Sweden
277EUCTR2017-004886-29-GB03/07/201802/07/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1224Phase 3France;Czech Republic;Estonia;Finland;Spain;Ireland;Denmark;Netherlands;United Kingdom;Sweden
278EUCTR2016-004719-10-PT02/07/201812/02/2018A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 21.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
800 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden
279EUCTR2017-001362-25-DK27/06/201821/03/2018 Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS Relapsing remitting multiple sclerosis.
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Helse Bergen HF, Haukeland University HospitalNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noDenmark;Netherlands
280EUCTR2017-002632-17-SK26/06/201817/04/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
445Phase 4Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Portugal;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281EUCTR2017-002631-42-FI26/06/201828/02/2018A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 4Finland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden
282EUCTR2017-004886-29-DK21/06/201818/05/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1224Phase 3Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
283EUCTR2017-001313-93-HU21/06/201825/04/2018A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple SclerosisAN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS Progressive multiple sclerosis (PMS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10053395Term: Progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
284EUCTR2017-004886-29-FI19/06/201815/06/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Estonia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
285NCT03493841June 8, 201821/3/2018Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple SclerosisComparing Gastrointestinal Tolerability and Absorption of Racemic Lipoic Acid and R-lipoic Acid in Progressive Multiple Sclerosis: a Randomized Crossover TrialMultiple Sclerosis;Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple SclerosisDrug: Alpha Lipoic AcidRebecca SpainNULLCompleted18 YearsN/AAll20Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286EUCTR2017-000635-13-DE08/06/201822/02/2018Escalating therapy in steroid-refractory relapses of multiple sclerosis – comparison of methylprednisolone to immunoadsorptionEscalating therapy in steroid-refractory relapses of multiple sclerosis – comparison of methylprednisolone to immunoadsorption Multiple Sclerosis (MS), acute episode
MedDRA version: 20.0Level: HLTClassification code 10052785Term: Multiple sclerosis acute and progressiveSystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE
Universität LeipzigNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Germany
287EUCTR2017-001313-93-PL08/06/201815/03/2018A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple SclerosisAN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS Progressive multiple sclerosis (PMS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
288NCT03526224June 4, 20183/5/2018Teriflunomide Tecfidera LMCEEffect of Teriflunomide on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective Observational Case-control Pilot StudyTecfidera;TeriflunomideDrug: Dimethyl Fumarate;Drug: TeriflunomideUniversity at BuffaloNULLUnknown status18 Years65 YearsAll120United States
289EUCTR2017-004886-29-EE31/05/201818/04/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
290EUCTR2017-002632-17-BE24/05/201801/02/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
445 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesPortugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291EUCTR2017-004886-29-ES22/05/201809/04/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Roche Farma SA (Soc unipersonal) que realiza el ensayo en España y que actúa como representante F.Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noEstonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
292NCT03610139May 21, 201813/7/2018Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis PatientsLongitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients: A Single-Blind Randomized Clinical TrialMultiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting;Clinically Isolated Syndrome;Clinically Isolated Syndrome, CNS Demyelinating;Vitamin D3 DeficiencyDietary Supplement: Vitamin D3American University of Beirut Medical CenterNULLUnknown status18 YearsN/AAll162N/ALebanon
293EUCTR2017-002631-42-GB21/05/201818/12/2017A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
265Phase 4Finland;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden
294EUCTR2017-002632-17-NL14/05/201827/02/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
445 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesPortugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
295EUCTR2017-001313-93-ES11/05/201802/03/2018A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple SclerosisAN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS Progressive multiple sclerosis (PMS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10053395Term: Progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Roche Farma S.A(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F. Hoffmann-La Roche LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296EUCTR2017-002631-42-BE09/05/201822/02/2018 A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesFinland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden
297NCT03574428May 8, 201816/5/2018Single Ascending Doses Study With GNbAC1 in Healthy Male VolunteersA Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male VolunteersMultiple SclerosisDrug: GNbAC1;Other: GNbAC1 PlaceboGeNeuro Australia PTY LtdNULLCompleted18 Years55 YearsMale24Phase 1Australia
298EUCTR2012-000541-12-BE07/05/201809/02/2018Clinical study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®)Multicenter, randomized, double-blind, parallel-group, add-on, superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who are treated with dimethyl fumarate (Tecfidera®) - POINT Relapsing multiple sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: PONESIMOD
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;United States;Greece;Finland;Spain;Austria;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany
299EUCTR2017-001313-93-IE03/05/201806/02/2018A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple SclerosisAN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS Progressive multiple sclerosis (PMS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10053395Term: Progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01 (development)
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01 (commercial)
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
300EUCTR2017-004101-40-HR27/04/201816/05/2019Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with SpasticityAn Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). Spasticity in patients with multiple sclerosis
MedDRA version: 20.0Level: LLTClassification code 10041416Term: SpasticitySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen
Osmotica Pharmaceutical US LLCNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301EUCTR2017-004100-22-HR27/04/201816/05/2019Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Multiple Sclerosis (Study OS440-3004) Spasticity in patients with multiple sclerosis
MedDRA version: 20.0Level: LLTClassification code 10041416Term: SpasticitySystem Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen
Osmotica Pharmaceutical US LLCNULLNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
302EUCTR2016-004719-10-GB26/04/201822/05/2018A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT relapsing multiple sclerosis
MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PONESIMOD
Product Name: Ponesimod
Product Code: ACT-128800
INN or Proposed INN: PO
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden
303EUCTR2017-002632-17-CZ25/04/201829/01/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
304EUCTR2017-002631-42-CZ25/04/201830/01/2018 A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
265 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesFinland;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden
305EUCTR2018-000620-34-SE24/04/201814/03/2018Imatinib treatment for Multiple Sclerosis (MS) RelapsesImatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: LLTClassification code 10028247Term: Multiple sclerosis like syndromeSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
INN or Proposed INN: IMATINIB MESILATE
Trade Name: Solu-Medrol
Product Name: Solu-Medrol
INN or Proposed INN: Methylprednisolone
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Department of Clinical Neuroscience, Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306EUCTR2017-002632-17-SE18/04/201817/01/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
445 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesPortugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
307EUCTR2017-002631-42-SE18/04/201805/12/2017A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis