13. 多発性硬化症/視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238

  
295 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05658484
(ClinicalTrials.gov)
April 13, 202312/12/2022A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in ChinaA Multicenter, Postmarketing Study of Dimethyl Fumarate (Tecfidera; BG00012) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in ChinaMultiple SclerosisDrug: Dimethyl fumarateBiogenNULLNot yet recruiting18 Years65 YearsAll60Phase 4NULL
2NCT05754593
(ClinicalTrials.gov)
April 202321/2/2023Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis (MS), Compared to a Control GroupStudy of Ovarian Reserve Concerning Patients With Multiple Sclerosis, Compared to a Control GroupMultiple SclerosisBiological: Anti-Mullerian hormone (AMH) level;Other: Antral follicle count (AFC);Other: Clinical assessmentUniversity Hospital, BordeauxNULLNot yet recruiting25 Years35 YearsFemale160N/AFrance
3NCT05349474
(ClinicalTrials.gov)
April 26, 202221/4/2022Metformin Treatment in Progressive Multiple SclerosisA Double-blind, Placebo Controlled Trial of Metformin Treatment in Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis;Primary Progressive Multiple SclerosisDrug: Metformin 500 Mg Oral Tablet, up to 4 tablets a day;Drug: Placebo oral tablet identical to metformin, up to 4 tablets a dayUniversity of California, Los AngelesNULLRecruiting30 Years65 YearsAll44Early Phase 1United States
4EUCTR2021-000028-36-LT
(EUCTR)
21/04/202204/11/2021Not applicableA Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1) - ENSURE-1 Relapsing Multiple Sclerosis
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]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IMU-838
Product Name: Vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IMU-838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1050Phase 3United States;Belarus;Greece;Ukraine;Lithuania;Russian Federation;North Macedonia;Colombia;India;Mexico;Poland;Bulgaria;Albania;Georgia;Moldova, Republic of
5NCT05296161
(ClinicalTrials.gov)
April 20, 202218/2/2022B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple SclerosisEfficacy, Safety and Cost-effectiveness of B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple Sclerosis: a Randomized Controlled TrialMultiple Sclerosis, Relapsing-RemittingDrug: OcrelizumabAmsterdam UMC, location VUmcNULLRecruiting18 Years60 YearsAll296Phase 4Netherlands
6NCT04998812
(ClinicalTrials.gov)
April 13, 20226/8/2021A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During PregnancyA Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During PregnancyMultiple Sclerosis;Clinically Isolated SyndromeDrug: OcrelizumabHoffmann-La RochePPD;Laboratory Corporation of America;Illingworth Research GroupRecruiting18 Years40 YearsFemale44Phase 4Switzerland;United Kingdom;France;Germany;Spain;United States;Canada;Italy
7NCT05417269
(ClinicalTrials.gov)
April 12, 20221/6/2022IMCY-0141 Safety and Efficacy in Multiple Sclerosis - ISEMIS StudyA Phase I/II Dose Escalation/Adaptive Design Study to Evaluate the Safety and Efficacy of IMCY-0141 in Patients With Relapsing Remitting-Multiple Sclerosis (RR-MS)Multiple Sclerosis, Relapsing-RemittingDrug: IMCY-0141;Drug: Placebo;Drug: Dimethyl FumarateImcyse SANULLRecruiting18 Years45 YearsAll150Phase 1/Phase 2Moldova, Republic of
8NCT05145361
(ClinicalTrials.gov)
April 7, 202221/11/2021Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody (AQP4-IgG) Positive Neuromyelitis Optic Spectrum Disorder (NMOSD)NMO Spectrum DisorderDrug: B001 injection;Biological: PlaceboShanghai Pharmaceuticals Holding Co., LtdNULLRecruiting18 Years70 YearsAll45Early Phase 1China
9NCT05319093
(ClinicalTrials.gov)
April 20221/4/2022Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis PatientsObservational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis PatientsFatigue;Multiple SclerosisDrug: OzanimodBrigham and Women's HospitalBristol-Myers SquibbNot yet recruiting18 YearsN/AAll40NULL
10NCT05284175
(ClinicalTrials.gov)
April 20229/3/2022A Study of Orelabrutinib in Patients With AQP4-IgG Positive Neuromyelitis Optica Spectrum DisorderA Prospective, Self-controlled Study to Explore Efficacy and Safety of Orelabrutinib in AQP4-IgG Positive Neuromyelitis Optica Spectrum DisorderNeuromyelitis Optica Spectrum DisorderDrug: OrelabrutinibPeking Union Medical College HospitalBeijing InnoCare Pharma Tech Co., Ltd.;GCP ClinPlus Co., Ltd.Not yet recruiting18 Years75 YearsAll23N/AChina
11EUCTR2021-000028-36-BG
(EUCTR)
18/01/202208/11/2021Not applicableA Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1) - ENSURE-1 Relapsing Multiple Sclerosis
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]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IMU-838
Product Name: Vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IMU-838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1050Phase 3Colombia;Russian Federation;United States;Ukraine;Belarus;India;Albania;Greece;Moldova, Republic of;Poland;North Macedonia;Mexico;Georgia;Bulgaria;Lithuania
12EUCTR2021-000062-14-DE
(EUCTR)
25/11/202125/08/2021A Study to Evaluate B Cell Levels in Infants Potentially Exposed to Ocrelizumab During PregnancyA PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS POTENTIALLY EXPOSED TO OCRELIZUMAB DURING PREGNANCY – THE MINORE STUDY Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 4France;United States;Canada;Spain;Germany;United Kingdom;Switzerland;Italy
13EUCTR2021-000063-79-DE
(EUCTR)
25/11/202125/08/2021A Study to Evaluate B Cell Levels in Infants of Lactating Women with Clinically Isolated Syndrome or Multiple sclerosis Receiving OcrelizumabA PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS OF LACTATING WOMEN WITH CIS OR MS RECEIVING OCRELIZUMAB – THE SOPRANINO STUDY Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]
MedDRA version: 20.0;Level: PT;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 4France;United States;Canada;Spain;Germany;United Kingdom;Switzerland;Italy
14EUCTR2021-000063-79-ES
(EUCTR)
22/10/202123/07/2021A Study to Evaluate B Cell Levels in Infants of Lactating Women with Clinically Isolated Syndrome or Multiple sclerosis Receiving OcrelizumabA PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS OF LACTATING WOMEN WITH CIS OR MS RECEIVING OCRELIZUMAB – THE SOPRANINO STUDY Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]
MedDRA version: 20.0;Level: PT;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 4France;United States;Canada;Spain;Australia;Germany;United Kingdom;Switzerland;Italy
15EUCTR2021-000062-14-ES
(EUCTR)
08/10/202123/07/2021A Study to Evaluate B Cell Levels in Infants Potentially Exposed to Ocrelizumab During PregnancyA PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS POTENTIALLY EXPOSED TO OCRELIZUMAB DURING PREGNANCY – THE MINORE STUDY Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 4France;United States;Canada;Spain;Australia;Germany;United Kingdom;Switzerland;Italy
16EUCTR2019-001341-40-SI
(EUCTR)
20/08/202112/07/2021An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes (PRO) in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod 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]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Saudi Arabia;Estonia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
17EUCTR2020-004785-19-DE
(EUCTR)
07/07/202117/02/2021Proof-of-concept study for SAR441344 in relapsing multiple sclerosisA Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis 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]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: Not Applicable
Other descriptive name: SAR441344
Sanofi-Aventis Recherche et DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany
18EUCTR2020-004785-19-CZ
(EUCTR)
01/06/202105/02/2021Proof-of-concept study for SAR441344 in relapsing multiple sclerosisA Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis 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]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: Not Applicable
Other descriptive name: SAR441344
Sanofi-Aventis Recherche et DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Bulgaria;Russian Federation;Germany
19EUCTR2020-003995-42-IT
(EUCTR)
13/05/202104/06/2021Extension 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: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD - 10 MG - COMPRESSA - USO ORALE - BLISTER (AL/AL) - 6 COMPRESSE
Product Name: Cladribine tablets
Product Code: [Not Applicable]
INN or Proposed INN: CLADRIBINA
MERCK KGAANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 4Hungary;Czech Republic;Canada;Finland;Poland;Australia;Israel;Germany;Italy
20NCT04540861
(ClinicalTrials.gov)
April 30, 202131/8/2020Managed Access Program (MAP) for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With Active DiseaseManaged Access Program (MAP) to Provide Access to Siponimod Treatment for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With no Satisfactory Alternative TreatmentMultiple SclerosisDrug: SiponimodNovartis PharmaceuticalsNULLAvailable18 YearsN/AAllNULL
21EUCTR2020-004785-19-BG
(EUCTR)
28/04/202109/03/2021Proof-of-concept study for SAR441344 in relapsing multiple sclerosisA Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis 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]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: Not Applicable
Other descriptive name: SAR441344
Sanofi-Aventis Recherche et DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany
22NCT04688788
(ClinicalTrials.gov)
April 28, 202122/12/2020Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple SclerosisDanish Non-inferiority Study of Ocrelizumab and Rituximab in MS (DanNORMS): A Randomized Study Comparing the Efficacy of Ocrelizumab and Rituximab in Active Multiple SclerosisRelapsing Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple SclerosisDrug: Rituximab;Drug: Ocrelizumab;Drug: Fexofenadine;Drug: Paracetamol;Drug: MethylprednisoloneRigshospitalet, DenmarkOdense University Hospital;Aarhus University Hospital;Aalborg University Hospital;Herlev Hospital;Hillerod Hospital, Denmark;Zealand University Hospital;Kolding Sygehus;Regional Hospital Holstebro;Hvidovre University Hospital;Hospital of South West Jutland, Esbjerg, Denmark;GCP unit, Copenhagen University Hospital;GCP-unit at Aarhus University Hospital, Aarhus, Denmark;Hospital of Southern Jutland, Sønderborg, Denmark;Hospital of Central Denmark Region, Viborg, Denmark;Danske RegionerRecruiting18 Years65 YearsAll594Phase 3Denmark
23NCT04843774
(ClinicalTrials.gov)
April 20, 20219/4/2021Vaccine-generated Immunity in Ocrelizumab-treated Patients: Longitudinal Assessments (VIOLA)Vaccine-generated Immunity in Ocrelizumab-treated Patients: Longitudinal Assessments (VIOLA)Multiple SclerosisDrug: SARS-COV-2 mRNA VaccineNYU Langone HealthNULLActive, not recruiting18 Years65 YearsAll64United States
24NCT04792567
(ClinicalTrials.gov)
April 19, 20218/3/2021Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)An Open-label Multicenter Study to Assess Response to SARS-CoV-2 modRNA Vaccines in Participants With Secondary Progressive Multiple Sclerosis Treated With Mayzent (Siponimod)Secondary Progressive Multiple SclerosisDrug: BAF312;Drug: Baseline disease modifying therapies (DMTs)Novartis PharmaceuticalsNULLCompleted18 Years100 YearsAll41Phase 4Germany
25NCT04742400
(ClinicalTrials.gov)
April 15, 20215/2/2021Tolebrutinib, a Brain-penetrant Bruton s Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple SclerosisA Phase 2 Clinical Trial of Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple SclerosisMultiple SclerosisDrug: tolebrutinib 60mg;Drug: tolebrutinib 120mgNational Institute of Neurological Disorders and Stroke (NINDS)NULLActive, not recruiting18 YearsN/AAll11Phase 2United States
26EUCTR2020-003874-30-DK
(EUCTR)
06/04/202123/11/2020Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® doseA 2-year follow-up study to assess cognition and health-related quality oflife in participants with highly-active relapsing multiple sclerosis, havingparticipated in the CLARIFY MS trial - CLARIFY MS Extension Highly-active relapsing 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
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System 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 Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 4Hungary;Denmark
27NCT05385744
(ClinicalTrials.gov)
April 5, 202118/5/2022An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple SclerosisAn International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple SclerosisMultiple SclerosisBiological: BCD-132;Drug: TeriflunomideBiocadNULLRecruiting18 Years60 YearsAll336Phase 3Russian Federation
28JPRN-jRCT2031200333
02/03/202129/01/2021A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS 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 Disorder (NMOSD)Satralizumab: 120 mg SC injection every 4 weeks (Q4W)Hans-Christian von BuedingenNULLNot RecruitingNot applicableNot applicableBoth127Phase 4Italy;Taiwan;United States;Poland;Canada;United Kingdom;Ukraine;Bulgaria;Turkey;Korea;Romania;Georgia;Malaysia;Croatia;Hungary;Spain;Germany;Japan
29EUCTR2020-003995-42-CZ
(EUCTR)
03/02/202104/11/2020Extension 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: 20.0;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
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System 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 Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 4Hungary;Czech Republic;Canada;Finland;Australia;Israel;Germany
30EUCTR2020-003874-30-CZ
(EUCTR)
03/02/202104/11/2020Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® doseA 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension Highly-active relapsing 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
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System 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 Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 4Hungary;Czech Republic;Denmark;Italy
31EUCTR2020-003995-42-AT
(EUCTR)
26/01/202123/11/2020Extension 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: 20.0;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
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System 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 4Hungary;Czech Republic;Canada;Finland;Poland;Australia;Austria;Israel;Germany;Italy
32EUCTR2019-001341-40-PL
(EUCTR)
20/01/202117/07/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes (PRO) in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod 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]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Saudi Arabia;Estonia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
33EUCTR2020-003995-42-HU
(EUCTR)
18/01/202120/11/2020Extension 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: 20.0;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
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System 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 Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
47Phase 4Czech Republic;Hungary;Canada;Finland;Australia;Israel;Germany
34EUCTR2020-003874-30-HU
(EUCTR)
15/01/202120/11/2020Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® doseA 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension Highly-active relapsing 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
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System 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
320Phase 4Hungary
35EUCTR2020-003874-30-IT
(EUCTR)
08/01/202124/05/2021Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® doseA 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension Highly-active relapsing 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
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD - 10 MG - COMPRESSA - USO ORALE - BLISTER (AL/AL) - 6 COMPRESSE
Product Name: Cladribine tablets
Product Code: [Not Applicable]
INN or Proposed INN: CLADRIBINA
MERCK KGAANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 4France;Czechia;Hungary;Slovakia;Spain;Poland;Denmark;Austria;Netherlands;Italy
36EUCTR2020-003874-30-AT
(EUCTR)
29/12/202023/11/2020Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® doseA 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension Highly-active relapsing 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
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System 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
380Phase 4Hungary;Czech Republic;Denmark;Austria;Italy
37EUCTR2020-003995-42-DE
(EUCTR)
18/12/202029/10/2020Extension 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: 20.0;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
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System 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 Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
256Phase 4Hungary;Czech Republic;Canada;Finland;Poland;Australia;Israel;Germany
38EUCTR2020-003995-42-FI
(EUCTR)
15/12/202023/11/2020Extension 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: 20.0;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
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System 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
39JPRN-jRCT2051210017
15/10/202007/05/2021An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of InebilizumabAn extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisordersThis study is designed to provide the opportunity of continued access to inebilizumab to patients with NMOSD who received inebilizumab in the completed Study CD-IA-MEDI-551-1155. The fixed dose of 300 mg inebilizumab every 26 weeks is injected to maintain peripheral B-cell suppression in subjects.Sato ToshiyukiNULLNot Recruiting>= 18age oldNot applicableBoth7Phase 3Japan
40EUCTR2019-001341-40-AT
(EUCTR)
10/09/202007/07/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes (PRO) in patients with relapsing multiple sclerosis(RMS) transitioning from fumarate-based RMS approved therapies or fingolimod therapy 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]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
41EUCTR2019-004980-36-IT
(EUCTR)
31/08/202021/01/2021Evobrutinib 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: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: [M2951]
INN or Proposed INN: Evobrutinib
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
Product Code: [non applicabile]
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;Kuwait;Tunisia;Latvia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
42EUCTR2019-004972-20-IT
(EUCTR)
31/08/202021/01/2021Evobrutinib 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: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: [M2951]
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: AUBAGIO
Product Name: Aubagio
Product Code: [non applicabile]
INN or Proposed INN: TERIFLUNOMIDE
MERCK HEALTHCARE KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Canada;Argentina;Poland;Belgium;Croatia;Georgia;Serbia;United States;Estonia;Hong Kong;Taiwan;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Australia;Peru;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Bulgaria;Germany
43EUCTR2019-001341-40-SK
(EUCTR)
20/07/202016/03/2020An open-label study evaluating ofatumumab treatment effectiveness andPROs in subjects with RMS transitioning from fumarate-based RMSapproved therapies or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluateofatumumab treatment effectiveness and patient-reported outcomes (PRO)in patients with relapsing multiple sclerosis (RMS) transitioning fromfumarate-based RMS approved therapies or fingolimod 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]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Norway
44NCT04353492
(ClinicalTrials.gov)
July 14, 202016/4/2020An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to OfatumumabA Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient-reported Outcomes (PRO) in Patients With Relapsing Multiple Sclerosis (RMS) Transitioning From Fumarate-based RMS Approved Therapies or FingolimodRelapsing Multiple SclerosisBiological: OfatumumabNovartis PharmaceuticalsNULLActive, not recruiting18 Years60 YearsAll564Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Estonia;Germany;Greece;Hungary;Italy;Latvia;Lebanon;Mexico;Norway;Poland;Portugal;Russian Federation;Saudi Arabia;Slovakia;Slovenia;Spain;Switzerland;Turkey;United Kingdom
45EUCTR2017-003008-30-GB
(EUCTR)
01/07/202017/05/2018Simvastatin 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: 20.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System 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
46EUCTR2019-001341-40-BG
(EUCTR)
12/06/202007/05/2020An open-label study evaluating ofatumumab treatment effectiveness andPROs in subjects with RMS transitioning from fumarate-based RMSapproved therapies or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluateofatumumab treatment effectiveness and patient-reported outcomes (PRO)in patients with relapsing multiple sclerosis (RMS) transitioning fromfumarate-based RMS approved therapies or fingolimod 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]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Norway
47EUCTR2019-000069-19-RO
(EUCTR)
29/05/202022/03/2022Evaluating 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]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4France;Australia;Tunisia;Latvia;Korea, Republic of;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Norway;Sweden;Portugal;United States;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy
48EUCTR2019-001341-40-GR
(EUCTR)
20/05/202010/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies 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 (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod 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]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
49NCT05081700
(ClinicalTrials.gov)
May 11, 202013/11/2020A Systems Approach to Understanding Disease Processes in Multiple SclerosisA Systems Approach to Understanding Disease Processes in Multiple SclerosisMultiple SclerosisDrug: All patients in the study will be treated with ocrelizumabProvidence Health & ServicesInstitute for Systems Biology;Genentech, Inc.Active, not recruiting18 Years60 YearsAll14United States
50EUCTR2019-001341-40-DE
(EUCTR)
08/05/202005/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies 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 (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod. 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]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
51NCT04267926
(ClinicalTrials.gov)
April 1, 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
52EUCTR2019-000069-19-HR
(EUCTR)
24/12/201920/02/2020Evaluating 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]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Portugal;Serbia;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;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
53EUCTR2019-000069-19-AT
(EUCTR)
20/11/201906/06/2019Evaluating 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: 20.0;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]
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
54EUCTR2019-000069-19-PT
(EUCTR)
14/10/201913/05/2019Evaluating 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: 20.0;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]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4Serbia;Estonia;United States;Portugal;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
55EUCTR2019-000069-19-IT
(EUCTR)
11/10/201901/09/2021Evaluating 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]
Trade Name: MAVENCLAD
Product Name: Cladribina
Product Code: [Not applicable]
MERCK KGAANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
56EUCTR2019-000069-19-PL
(EUCTR)
08/09/201927/06/2019Evaluating 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: 20.0;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]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Portugal;Serbia;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;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
57EUCTR2019-000069-19-BG
(EUCTR)
05/09/201904/06/2019Evaluating 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: 20.0;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]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Portugal;Serbia;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;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
58EUCTR2019-000069-19-LT
(EUCTR)
27/08/201910/06/2019Evaluating 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: 20.0;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]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Portugal;Serbia;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;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
59EUCTR2019-000069-19-ES
(EUCTR)
23/08/201904/07/2019Evaluating 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]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: CLADRIBINE
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Serbia;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;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
60EUCTR2019-000069-19-SE
(EUCTR)
14/08/201910/05/2019Evaluating 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: 20.0;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]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Serbia;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;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
61EUCTR2019-000069-19-CZ
(EUCTR)
12/07/201907/05/2019Evaluating 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: 20.0;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]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: 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
62EUCTR2019-000069-19-EE
(EUCTR)
17/06/201922/05/2019Evaluating 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]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;United States;Portugal
63NCT03824938
(ClinicalTrials.gov)
April 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 Tablet 650mg;Other: PlaceboColumbia UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Completed18 Years70 YearsAll60Phase 3United States
64NCT03816345
(ClinicalTrials.gov)
April 4, 201924/1/2019Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Solid Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Hematopoietic and Lymphoid Cell Neoplasm;Inflammatory Bowel Disease;Metastatic Malignant Solid Neoplasm;Multiple Sclerosis;Psoriasis;Psoriatic Arthritis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Solid NeoplasmProcedure: Biospecimen Collection;Biological: NivolumabNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll300Phase 1United States;Canada
65NCT03853746
(ClinicalTrials.gov)
April 1, 201922/2/2019Short-term B-cell Depletion in Relapsing Multiple SclerosisEvaluating the Effects of Short-term B-cell Depletion on Long-term Disease Activity and Immune Tolerance in Relapsing Multiple SclerosisMultiple SclerosisDrug: OcrelizumabJohns Hopkins UniversityNational Multiple Sclerosis SocietyActive, not recruiting18 Years99 YearsAll10Phase 4United States
66NCT03710655
(ClinicalTrials.gov)
April 20196/10/2018Evaluate Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and Quality of Life in MS PatientsMulti-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and QOL in MS PatientsMultiple SclerosisDrug: Apitox - pure honeybee toxin;Drug: PlaceboApimeds, Inc.NULLUnknown status18 Years65 YearsAll468Phase 3NULL
67NCT03889639
(ClinicalTrials.gov)
March 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 magnetic resonance imaging (MRI)SanofiNULLCompleted18 Years55 YearsAll130Phase 2United States;Canada;Czechia;Estonia;France;Netherlands;Russian Federation;Slovakia;Spain;Ukraine;Sweden
68NCT05236777
(ClinicalTrials.gov)
January 1, 20192/2/2022TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated ParticipantsLong-term Surveillance of Patients With Multiple Sclerosis to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections Among Patients Treated With NatalizumabMultiple SclerosisDrug: NatalizumabBiogenAssociation for Functional Rehabilitation, Recreation and Applied Kinesiology ImpulseRecruitingN/AN/AAll600Czechia
69EUCTR2017-004158-40-FR
(EUCTR)
11/09/201804/07/2018NAA 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]
Product Name: Ocrevus
INN or Proposed INN: ocrelizumab
Other descriptive name: ocrelizumab
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
71 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
70NCT03464448
(ClinicalTrials.gov)
April 17, 20187/3/2018Mechanistic Studies of Teriflunomide in RRMSMechanistic Studies of Teriflunomide in Relapsing Remitting Multiple Sclerosis: Regulatory B Lymphocytes as Central Mediators of the Therapeutic Effects of Teriflunomide in MSRelapsing Remitting Multiple SclerosisDrug: TeriflunomideUniversity of MichiganNULLCompleted18 Years65 YearsAll30United States
71NCT03266965
(ClinicalTrials.gov)
March 23, 20184/7/2017Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel ApproachHistaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel ApproachMultiple SclerosisDrug: Carbidopa;Dietary Supplement: L-HistidineUniversity of MiamiUnited States Department of DefenseCompleted18 Years60 YearsAll18Phase 1United States
72ChiCTR-DND-17013749
2017-12-012017-12-07Application of 3.0 T MRI 3D sequences of CUBE-T2 FLAIR?DIR for brain lesions of childhood-onset multiple sclerosisApplication of 3.0 T MRI 3D sequences of CUBE-T2 FLAIR?DIR for brain lesions of childhood-onset multiple sclerosis childhood-onset multiple sclerosisGold Standard:CUBE-T2 FLAIR scanning;Index test:DIR scanning;Children's Hospital of Chongqing Medical UniversityNULLRecruitingBothTarget condition:80;Difficult condition:0China
73EUCTR2017-002634-24-SE
(EUCTR)
29/09/201706/07/2017MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis.MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS Newly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Gilenya
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Extavia
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name:
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Sweden
74NCT03345940
(ClinicalTrials.gov)
April 30, 201716/5/2017Fingolimod Versus Dimethyl-fumarate in Multiple SclerosisA Multicentric Randomized PRAGmatic Trial to Compare the Effectiveness of Fingolimod Versus Dimethyl-Fumarate on Patient Overall Disease Experience in Relapsing Remitting Multiple Sclerosis: Novel Data to Inform Decision-makersRelapsing Remitting Multiple SclerosisDrug: Fingolimod;Drug: Dimethyl FumarateFondazione I.R.C.C.S. Istituto Neurologico Carlo BestaPatient-Centered Outcomes Research Institute;Universita degli Studi di GenovaTerminated18 YearsN/AAll55Phase 4Italy
75NCT03073603
(ClinicalTrials.gov)
April 20, 201718/1/2017Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)Multiple SclerosisDrug: Discontinuation of disease modifying therapy;Drug: Standard of CareUniversity of Colorado, DenverPatient-Centered Outcomes Research Institute;National Multiple Sclerosis Society;University of Alabama at BirminghamCompleted55 YearsN/AAll259Phase 4United States
76NCT02881567
(ClinicalTrials.gov)
April 18, 201724/8/2016Efficacy and Safety of Daclizumab in Participants With RRMS Switching From NatalizumabA Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN)Relapsing-Remitting Multiple Sclerosis (RRMS)Drug: DaclizumabBiogenAbbVieTerminated18 Years55 YearsAll41Phase 3United States;Canada;Germany;Italy;Puerto Rico;France;United Kingdom
77EUCTR2015-001202-34-IT
(EUCTR)
04/05/201608/06/2021A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier damage in Multiple Sclerosis patients with high cortical disease activity,A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier damage in Multiple Sclerosis patients with high cortical disease activity. Correlation between [11C]-PK-11195 or [18F]-NAF PET (Positron Emission Tomography) and high field MRI (Magnetic Resonance Imaging): a synergistic effect by using a double-technique approach. - A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier Multiple Sclerosis
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Na18F
Product Code: Na18F
Product Name: [11C]-PK-11195
Product Code: [11C]-PK-11195
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
18Phase 2Italy
78NCT02688985
(ClinicalTrials.gov)
April 29, 201618/2/2016Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)An Open-Label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Patients With Relapsing Multiple Sclerosis or Primary Progressive Multiple SclerosisRelapsing Multiple Sclerorsis;Multiple Sclerosis, Primary ProgressiveDrug: Ocrelizumab;Procedure: Lumbar Puncture;Drug: Methyloprednisolone;Drug: AntihistamineGenentech, Inc.NULLActive, not recruiting18 Years55 YearsAll132Phase 3United States;Canada;Germany;Sweden
79NCT02782858
(ClinicalTrials.gov)
April 201623/5/2016Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MSAn International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: GNbAC1;Drug: PlaceboGeNeuro SALes Laboratoires Servier (LLS);Institut de Recherches Internationales Servier;Worldwide Clinical TrialsCompleted18 Years55 YearsAll270Phase 2Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine
80NCT02675413
(ClinicalTrials.gov)
April 201611/1/2016Mechanisms of Action of Dimethyl Fumarate (Tecfidera) in Relapsing MSMechanisms of Action of Dimethyl Fumarate in Relapsing MSMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Dimethyl FumarateWashington University School of MedicineBiogenWithdrawn18 YearsN/ABoth0Phase 4United States
81EUCTR2015-000922-12-DE
(EUCTR)
12/02/201602/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;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]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
82EUCTR2015-000922-12-FR
(EUCTR)
28/01/201626/02/2016A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;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]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot Recruiting Female: yes
Male: yes
840 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
83EUCTR2015-000922-12-PL
(EUCTR)
05/01/201603/12/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;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]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
84EUCTR2015-000922-12-BE
(EUCTR)
04/01/201601/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;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]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
85EUCTR2015-000922-12-IE
(EUCTR)
22/12/201509/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;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]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot Recruiting Female: yes
Male: yes
840 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
86EUCTR2015-004116-38-SE
(EUCTR)
18/12/201520/10/2015A clincial study comparing the effectiveness of two drugs, named Rituximab and Dimethyl Fumarate (Tecfidera®), for the neurological disease Multiple Sclerosis.RItuximab versus FUmarate in Newly Diagnosed Multiple Sclerosis – RIFUND-MSA randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple SclerosisObjective: To compare the efficacy of rituximab on the ability to prevent relapses in early RRMS and CIS compared with dimethyl fumarate (DMF), which is an approved first-line medication for RRMS today, using a phase 3 design.Population: Patients with newly diagnosed RRMS or CIS with no more than 10 years disease duration (since diagnosis), 18 – 50 years of age and previously not treated with immunomodulating drugs OR treated with first-line injectables. Patients should display protocol-defined clinical or radiological disease activity during the preceding year before screening for inclusion.Intervention: Treatment with rituximab (Mabthera®) with an initial dose of 1000 mg intravenously (iv) followed by 500 mg iv every six months.Control: Treatment with DMF (Tecfidera®) 240 mg twice daily. The two treatments are randomised in a 1:1 proportion.Outcome: Primary outcome is the relative risk of experiencing a relapse during the two–year period for either compound. As secondary endpoints worsening on neurological disability, magnetic-resonance imaging-defined disease activity and effect on cerebrospinal fluid biomarkers will be analysed. In addition, health-economic evaluations of using rituximab as first-line treatment for RRMS will be performed. Patients with multiple sclerosis (MS) or patients presenting with symptoms highly suspicious of MS while not completely fulfilling diagnostic criteria, 18 - 50 years of age and no more than 10 years of disease duration (from diagnosis). Patients treated with immunomodulatory drugs or treated with first-line injectable therapies (eg interferons or glatiramer acetate) may be included.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Department of Clinical Sciences, Danderyd HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Sweden
87EUCTR2015-000922-12-FI
(EUCTR)
15/12/201507/12/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;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]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
88EUCTR2015-000922-12-HR
(EUCTR)
11/12/201504/02/2016A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;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]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
89EUCTR2015-000922-12-AT
(EUCTR)
19/11/201501/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;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]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
90EUCTR2014-004483-38-DE
(EUCTR)
16/07/201528/04/2015TMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trialTMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trial Patients with defined diagnosis of relapsing-remitting multiple sclerosis and at least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years.
MedDRA version: 19.0;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]
Product Name: Tarenflurbil
Product Code: TMP001
INN or Proposed INN: Tarenflurbil
Other descriptive name: FLURBIPROFEN
Fraunhofer Gesellschaft for its Institute Fraunhofer Institute for Molecular Biology and Applied Ecology (IME)NULLNot RecruitingFemale: yes
Male: yes
55Phase 2Germany
91JPRN-UMIN000018154
2015/07/0101/07/201511C-acetate PET for Multiple sclerosis11C-acetate PET for Multiple sclerosis - 11C-acetate PET for Multiple sclerosis Multiple Sclerosis, NMOWithdraw blood before and after the injection of 11C-acetatedepartment of neurology, Osaka university school of medicineNULLRecruiting20years-old75years-oldMale and Female30Not applicableJapan
92NCT02665221
(ClinicalTrials.gov)
July 201522/1/2016Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDYSingle Center, Randomized, Open Label Study in Relapsing MS Patients on PLEGRIDY to Assess Topical Application of Preparation H (Phenylephrine) on Mitigation of Erythema Severity and Size.Multiple SclerosisOther: No Treatment Arm;Drug: Topical Preparation H armNew York University School of MedicineNULLTerminated18 Years70 YearsAll32Phase 4United States
93NCT02423083
(ClinicalTrials.gov)
April 21, 201521/4/2015Oral Guanabenz for Multiple SclerosisPhase I Study of Oral Guanabenz for Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Multiple SclerosisDrug: GuanabenzNational Institute of Neurological Disorders and Stroke (NINDS)NULLTerminated18 Years55 YearsAll2Phase 1United States
94NCT04928313
(ClinicalTrials.gov)
April 12, 201514/4/2021Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in IranA Phase IV, Post-marketing, Prospective, Multicenter Study to Investigate the Safety and Effectiveness of Cinnomer® (Glatiramer-Acetate) in Multiple Sclerosis (MS) Treatment in IranRelapsing Multiple SclerosisDrug: Glatiramer AcetateCinnagenNULLCompleted18 Years60 YearsAll368Phase 4NULL
95NCT02200770
(ClinicalTrials.gov)
April 1, 201516/7/2014N-MOmentum: A Clinical Research Study of Inebilizumab in 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 DisordersNeuromyelitis Optica and Neuromyelitis Optica Spectrum DisordersDrug: Inebilizumab;Other: PlaceboMedImmune LLCNULLCompleted18 YearsN/AAll231Phase 2/Phase 3United States;Australia;Bulgaria;Canada;Colombia;Czechia;Estonia;Germany;Hong Kong;Hungary;Israel;Japan;Korea, Republic of;Mexico;Moldova, Republic of;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Turkey;China;Czech Republic;Greece;India;Netherlands;Portugal;Ukraine
96NCT02391961
(ClinicalTrials.gov)
April 1, 20153/3/2015Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple SclerosisStudy and Treatment of Visual Dysfunction and Motor Fatigue in Multiple SclerosisMultiple Sclerosis;Internuclear Ophthalmoplegia;FatigueDrug: Dalfampridine;Drug: PlaceboVA Office of Research and DevelopmentNULLCompleted18 Years65 YearsAll23Phase 2United States
97NCT02939079
(ClinicalTrials.gov)
April 201514/10/2016Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis PatientsEvaluating the Effect of Fingolimod With Fish Oil Compared to Fingolimod With Placebo on Tumor Necrosis Factor-a , Interleukin1b , Interleukin6, and Interferon-gamma in Patients With Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: Fingolimod;Dietary Supplement: Fish Oil;Drug: Placebo (for Fish Oil)Isfahan University of Medical SciencesShiraz University of Medical SciencesCompleted18 Years45 YearsAll50Phase 2/Phase 3NULL
98NCT02398461
(ClinicalTrials.gov)
April 201513/3/2015An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a RelapseA Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a RelapseMultiple Sclerosis, Acute RelapsingDrug: rHIgM22;Drug: PlaceboAcorda TherapeuticsPRA Health SciencesCompleted18 Years70 YearsAll27Phase 1United States
99NCT02428231
(ClinicalTrials.gov)
April 201523/4/2015Tecfidera Slow-Titration StudyA Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients With Multiple SclerosisMultiple SclerosisDrug: dimethyl fumarateBiogenNULLTerminated18 Years65 YearsAll62Phase 3United States;Belgium;Czech Republic;Italy;Australia;Canada;France;Germany;Hungary;Spain
100EUCTR2013-002378-26-SE
(EUCTR)
13/11/201415/08/2013Switch To RItuXimab in MS extensionAn extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytesSwitch To RItuXimab in MS extensionAn extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSext The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial.
MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mabthera®
Product Name: Mabthera
Västerbottens Läns LandstingNULLNot RecruitingFemale: yes
Male: yes
74Phase 2Sweden
101EUCTR2013-003126-83-DE
(EUCTR)
23/06/201417/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
102EUCTR2013-003126-83-GR
(EUCTR)
27/05/201425/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Denmark;Peru;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
103EUCTR2013-002351-15-ES
(EUCTR)
26/05/201425/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-?-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-?-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 17.0;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]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3Serbia;Portugal;Belarus;United States;United Arab Emirates;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Peru;Denmark;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden
104EUCTR2013-003126-83-ES
(EUCTR)
26/05/201405/03/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-?-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-?-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3Serbia;Belarus;United States;United Arab Emirates;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
105EUCTR2013-003126-83-HU
(EUCTR)
21/05/201421/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Denmark;Peru;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
106EUCTR2013-002351-15-BG
(EUCTR)
21/05/201420/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;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]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Interferon-ß-1a
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden
107EUCTR2013-002351-15-HU
(EUCTR)
21/05/201421/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;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]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden
108EUCTR2013-002351-15-PT
(EUCTR)
09/05/201425/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;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]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Portugal;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden
109NCT02579681
(ClinicalTrials.gov)
April 30, 201416/10/2015Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012Multiple Sclerosis, Relapsing-RemittingDrug: dimethyl fumarateBiogenNULLCompleted18 YearsN/AAll221Phase 3Italy
110EUCTR2013-003126-83-BG
(EUCTR)
16/04/201420/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Interferon-ß-1a
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Serbia;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
111NCT01892345
(ClinicalTrials.gov)
April 11, 201420/6/2013A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)Neuromyelitis Optica;Neuromyelitis Optica Spectrum DisorderDrug: Eculizumab;Drug: PlaceboAlexion PharmaceuticalsNULLTerminated18 YearsN/AAll143Phase 3United States;Argentina;Australia;Croatia;Czechia;Denmark;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Malaysia;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Canada;Colombia;Czech Republic;France;Singapore
112NCT01973517
(ClinicalTrials.gov)
April 201416/10/2013High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases7T MRI Ferumoxytol-Enhanced Characterization of Multiple Sclerosis and Demyelinating DiseasesMultiple SclerosisDrug: Feraheme;Drug: Gadolinium-based contrastStanford UniversityNULLWithdrawn18 YearsN/AAll0United States
113NCT04256252
(ClinicalTrials.gov)
April 20142/2/2020Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE)Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE): a Prospective, Multicenter, Open-label, Follow-up Clinical TrialNeuromyelitis Optica Spectrum DisorderDrug: RituximabTang-Du HospitalNULLCompleted16 Years75 YearsAll108Phase 4NULL
114NCT01933802
(ClinicalTrials.gov)
April 201423/8/2013Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Patients With Multiple SclerosisPhase 1 Safety Study of Autologous Bone Marrow-derived Mesenchymal Stem Cell-derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo, Administered Intrathecally in Patients With Multiple SclerosisMultiple SclerosisBiological: intrathecal administration of autologous MSC-NPTisch Multiple Sclerosis Research Center of New YorkNULLCompleted18 Years70 YearsAll20Phase 1United States
115NCT02865018
(ClinicalTrials.gov)
April 20149/8/2016Neuromyelitis Optica (NMO) & CetirizineAn Open Label, add-on Trial of Cetirizine for Patients With Neuromyelitis OpticaNeuromyelitis OpticaDrug: cetirizineIcahn School of Medicine at Mount SinaiGuthy Jackson FoundationCompleted18 Years85 YearsBoth16Phase 1/Phase 2United States
116EUCTR2013-002351-15-EE
(EUCTR)
13/03/201418/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;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]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden
117EUCTR2013-002351-15-AT
(EUCTR)
13/03/201428/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;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]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden
118EUCTR2013-002351-15-LV
(EUCTR)
03/03/201420/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;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]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden
119JPRN-UMIN000012705
2014/01/0707/01/2014The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosisThe efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis - Treatment with an anti-interleukin-6 receptor antibody for relapsing-remitting multiple sclerosis Relapsing-remitting multiple sclerosisTocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 2 years.Department of Immunology, National Institute of Neuroscience, NCNPNULLRecruiting20years-old65years-oldMale and Female10Not applicableJapan
120EUCTR2012-004165-41-GB
(EUCTR)
04/11/201319/09/2013Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized StudyHematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - Hematopoietic Stem Cell Therapy for Inflammatory MS Inflammatory Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: natalizumab
Trade Name: Fingolimod
Product Name: Gilenya
INN or Proposed INN: Fingolimod
Trade Name: Tecfidera
Product Name: Tecfidera
Product Code: BG-12 120
INN or Proposed INN: dimethyl fumarate
Northwestern UniversityNULLNot RecruitingFemale: yes
Male: yes
110Phase 2United States;United Kingdom
121NCT03133403
(ClinicalTrials.gov)
November 201321/4/2016Hematopoietic Stem Cell Therapy for Inflammatory Multiple Sclerosis Failing Alternate Approved TherapyHematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized StudyMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Tecfidera (BG12);Drug: Gilenya;Drug: Tysabri®;Drug: Avonex/Betaseron/Copaxone/Rebif;Procedure: Hematopoietic stem cell transplantation (HSCT)Sheffield Teaching Hospitals NHS Foundation TrustNULLRecruiting18 Years55 YearsAll5Phase 2/Phase 3United Kingdom
122JPRN-UMIN000011111
2013/07/1615/07/2013Spinal blood flow and metabolism in neurological diseasesSpinal blood flow and metabolism in neurological diseases - Spinal blood flow and metabolism in neurological diseases motor neuron disease including ALS, multiple sclerosis, stroke, Parkinson disease, spinocerebellar degeneration, multiple system atrophyPET scan study with 11C-flumazenil
PET scan study with 18F- FDG
PET scan study with 15O-H2O
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesNULLRecruiting20years-oldNot applicableMale and Female70Not applicableJapan
123NCT03198351
(ClinicalTrials.gov)
April 25, 201322/6/2017An Observational Study on Teriflunomide-exposed PregnanciesTeriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy ProjectMultiple SclerosisDrug: Teriflunomide (HMR1726)SanofiNULLRecruiting16 YearsN/AFemale325United States;Canada
124NCT01888354
(ClinicalTrials.gov)
April 201316/5/2013Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ)Versus ACTHar Gel Five Days SQ for the Treatment of MS ExacerbationsPilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ) Versus ACTHar Gel Five Days SQ for the Treatment of MS ExacerbationsMultiple Sclerosis (MS)Drug: H.P. Acthar Gel (repository corticotropin injection)The University of Texas Health Science Center, HoustonNULLCompleted18 Years55 YearsBoth25Phase 4United States
125NCT01808885
(ClinicalTrials.gov)
April 201312/2/2013Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.Relapsing Remitting Multiple SclerosisDrug: olesoxime (TRO19622);Drug: placeboHoffmann-La RocheHôpital de la Timone;SGS S.A.;STRAGEN ServicesCompleted18 YearsN/ABoth44Phase 1France
126NCT01767701
(ClinicalTrials.gov)
April 20137/1/2013Raltegravir (Isentress) Pilot Study in Relapsing Multiple SclerosisA Phase II Baseline Versus Treatment Study to Determine the Efficacy of Raltegravir (Isentress) in Preventing Progression of Relapsing Remitting Multiple Sclerosis as Determined by Gadolinium-enhanced MRIRelapsing Remitting Multiple SclerosisDrug: RaltegravirQueen Mary University of LondonMerck Sharp & Dohme Corp.Completed18 Years55 YearsAll23Phase 2United Kingdom
127NCT01738347
(ClinicalTrials.gov)
April 201313/11/2012Assess Safety, Bio-distribution, Radiation Dosimetry and Optimize the Imaging Protocol of GEH120714 (18F) Injection in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS).Assess Safety, Bio-distribution, and Radiation Dosimetry, and Optimize the Imaging Protocol of GEH120714 (18F) Injection, a Marker of Microglial Activation, in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS)Relapsing-remitting Multiple Sclerosis (rrMS)Drug: Arm 1 - GEH120714 (18F) InjectionGE HealthcareCentre for Probe Development and CommercializationCompleted20 Years50 YearsAll30Phase 1Canada;United States
128NCT01844232
(ClinicalTrials.gov)
April 201324/4/2013One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With SpasticityA One Year, Open Label, Dose Escalation Study To Evaluate the Long-Term Safety of Arbaclofen Extended Release Tablets (AERT) in Multiple Sclerosis Subjects With SpasticityMultiple Sclerosis;SpasticityDrug: arbaclofenRVL Pharmaceuticals, Inc.Osmotica Pharmaceutical US LLCCompleted18 Years70 YearsAll150Phase 3United States;Russian Federation;Ukraine
129EUCTR2012-003418-15-AT
(EUCTR)
23/10/201209/11/2012Methylphenidate modified release as treatment of MS-associated fatigue.Methylphenidate modified release as treatment option of MS-associated fatigue. A single-center randomized double-blind placebo-controlled trial. Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off-label among others, with some success. Until now, methylphenidate has been successfully used to treat fatigue in HIVand parkinson´s disease, data on its efficacy in MS are not available.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Ritalin LA 20mg capsules
Product Name: Methylphenidate modified release 20 mg
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Trade Name: Ritalin LA 30mg capsules
Product Name: Methylphenidate modified release 30 mg
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Trade Name: Ritalin LA 40mg capsules
Product Name: Methylphenidate modified release 40 mg
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Medizinische Universität WienNULLNot RecruitingFemale: yes
Male: yes
96Phase 2Austria
130EUCTR2009-017978-21-PL
(EUCTR)
17/08/201206/03/2012Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
131EUCTR2009-017978-21-PT
(EUCTR)
06/07/201211/08/2011Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
132JPRN-UMIN000009421
2012/06/2828/11/2012Efficacy and safety of rituximab for intractable immunogenic neurological disorder in childrenEfficacy and safety of rituximab for intractable immunogenic neurological disorder in children - rituximab for pediatric neurological disorder neuromyelitis optica (NMO), opsoclonus-myoclonus syndrome (OMS)administration of rituximabDepartment of Pediatrics, Kobe Universtiy Graduate School of MedicineNULLRecruitingNot applicable18years-oldMale and Female10Not applicableJapan
133NCT01623596
(ClinicalTrials.gov)
June 8, 201218/6/2012Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults With Relapsing Remitting Multiple Sclerosis (PREFERMS)Relapsing Remitting Multiple SclerosisDrug: Fingolimod;Drug: Disease Modifying therapyNovartis PharmaceuticalsNULLCompleted18 Years65 YearsAll881Phase 4United States;Puerto Rico
134JPRN-UMIN000007866
2012/05/0101/05/2012The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter StudyThe safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter Study - Tocilizumab in patients with neuromyelitis optica: Multicenter Study neuromyelitis opticaTocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 years.Department of Immunology, National Institute of Neuroscience, NCNPDepartment of Neurology, Kinki University Faculty of MediceineComplete: follow-up continuing20years-old65years-oldMale and Female15Not applicableJapan
135NCT01491100
(ClinicalTrials.gov)
April 30, 201212/12/2011Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple SclerosisStudy Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®Multiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted12 Years70 YearsAll1085Albania;Algeria;Argentina;Belgium;Czechia;Egypt;France;Germany;Greece;Hungary;Israel;Kazakhstan;Netherlands;Portugal;Saudi Arabia;Tunisia;Turkey;Bosnia and Herzegovina;Czech Republic;Jordan;Lebanon;Mexico;Poland;Syrian Arab Republic
136NCT01514370
(ClinicalTrials.gov)
April 30, 201217/1/2012Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1aProspeCtive Study to Evaluate Efficacy, Safety and tOlerability of Dietary supplemeNT of Curcumin (BCM95) in Subjects With Active Relapsing MultIple Sclerosis Treated With subcutaNeous Interferon Beta 1a 44 mcg Three Times a Week (TIW)Multiple SclerosisDrug: IFN beta 1a 44 mcg TIW;Drug: Curcumin;Drug: PlaceboMerck KGaA, Darmstadt, GermanyMerck Serono S.P.A., ItalyCompleted18 Years60 YearsAll80Phase 2Italy
137NCT01585298
(ClinicalTrials.gov)
April 29, 201223/4/2012STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)A 1-week, Open-label, Multi-center Study to Explore Conduction Abnormalities During First Dose Administration of Fingolimod in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: FTY720Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll6998Phase 4Germany
138NCT01585766
(ClinicalTrials.gov)
April 24, 20129/4/2012Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple SclerosisA Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple SclerosisMultiple Sclerosis, Relapsing FormsDrug: MEDI-551 30 MG-IV;Drug: MEDI-551 60 MG-SC;Drug: PLACEBO-IV-SC;Drug: MEDI-551 100 MG-IV;Drug: MEDI-551 300 MG-SC;Drug: MEDI-551 600 MG-IVMedImmune LLCNULLCompleted18 Years65 YearsAll56Phase 1United States;Poland;Spain;Ukraine;Czech Republic;United Kingdom
139NCT01480063
(ClinicalTrials.gov)
April 16, 201223/11/2011An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical PracticeA Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE)Multiple SclerosisDrug: FampridineBiogenNULLCompletedN/AN/AAll4734Argentina;Canada;Czechia;France;Germany;Ireland;Israel;Lebanon;Netherlands;Norway;Portugal;Spain;United Arab Emirates;Australia;Belgium;Czech Republic;Denmark
140NCT01627938
(ClinicalTrials.gov)
April 201230/5/2012Study to Evaluate the Reduction of Cardiac Problems in Multiple Sclerosis Patients With Mitoxantrone and Dexrazoxane in CombinationA Phase II Proof of Concept Study Evaluating the Reduction of Mitoxantrone-induced Cardiotoxicity and Neurological Outcome in the Combined Use of Mitoxantrone and Dexrazoxane (Cardioxane®) in Multiple Sclerosis (MSCardioPro)Multiple SclerosisDrug: Dexrazoxane (DRZ) plus Mitoxantrone (MX);Drug: Placebo plus Mitoxantrone (MX)PD Dr. Andrew ChanNULLActive, not recruiting18 Years55 YearsBoth50Phase 2Germany
141NCT01538225
(ClinicalTrials.gov)
April 201220/2/2012Neurophysiological Study of Sativex in Multiple Sclerosis (MS) SpasticityNeurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple SclerosisMultiple SclerosisDrug: Sativex®;Drug: PlaceboAlmirall, S.A.NULLCompleted18 YearsN/ABoth45Phase 3Italy
142EUCTR2009-017978-21-GR
(EUCTR)
17/01/201208/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3Serbia;Portugal;United Arab Emirates;United States;Estonia;Saudi Arabia;Taiwan;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
143NCT02280876
(ClinicalTrials.gov)
January 201220/10/2014Efficacy Study of Andrographis Paniculata Purified Standardized Extract (ApE) in Patients With Multiple Sclerosis (MS)Randomized, Comparative, Double Blind Controlled Phase II Clinical Trial, to Evaluate the Efficacy of ApE in Patients With Multiple Sclerosis (MS).Multiple Sclerosis, Relapsing-RemittingDrug: 1 - Andrographis paniculata p/st extract;Drug: 2 - ExcipientsUniversidad Austral de ChileComisión Nacional de Investigación Científica y Tecnológica;University of ChileCompleted18 Years55 YearsBoth30Phase 1/Phase 2Chile
144NCT01500408
(ClinicalTrials.gov)
January 201222/12/2011Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy VolunteersA Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of Interferon Beta-1a Manufactured by Two Different ProcessesMultiple SclerosisDrug: Interferon beta-1a (current approved manufacturing process invloving FBS);Drug: Interferon beta-1a (new process, manufactured without FBS)Biogen IdecNULLCompleted18 Years45 YearsBoth110Phase 1United States
145EUCTR2010-021219-17-DE
(EUCTR)
31/10/201105/07/2011A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosisA 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis - Not applicable Primary progressive or relapse-free secondary progressive multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: mastinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
INN or Proposed INN: masitinb mesylate
Product Name: mastinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
INN or Proposed INN: masitinb mesylate
AB ScienceNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;South Africa;Bulgaria;Germany;Tunisia;Bosnia and Herzegovina
146EUCTR2009-017978-21-DK
(EUCTR)
21/09/201112/09/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
147NCT01442194
(ClinicalTrials.gov)
August 1, 201121/8/2011Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying TherapiesLong-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying TherapyMultiple SclerosisDrug: other disease-modifying therapy;Drug: FingolimodNovartis PharmaceuticalsNULLCompletedN/AN/AAll3076United States;Argentina;Australia;Canada;Chile;Mexico;Puerto Rico
148EUCTR2009-017978-21-LT
(EUCTR)
25/07/201130/03/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
149EUCTR2009-017978-21-ES
(EUCTR)
13/07/201117/11/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry Pacientes con esclerosis múltiple que hayan participado en estudios con cladribina.
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2?-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
150EUCTR2009-017978-21-BE
(EUCTR)
12/07/201129/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;United Arab Emirates;Portugal;Serbia;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
151JPRN-UMIN000005889
2011/07/0108/07/2011The safety and efficacy of tocilizumab in patients with neuromyelitis opticaThe safety and efficacy of tocilizumab in patients with neuromyelitis optica - Tocilizumab in patients with neuromyelitis optica neuromyelitis opticaTocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 months.Department of Immunology, National Institute of Neuroscience, NCNPNULLComplete: follow-up complete20years-old65years-oldMale and Female3Not applicableJapan
152EUCTR2009-017978-21-SE
(EUCTR)
08/06/201103/05/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
153EUCTR2009-017978-21-CZ
(EUCTR)
06/06/201111/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2175Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
154EUCTR2009-017978-21-GB
(EUCTR)
03/06/201111/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
155EUCTR2009-017978-21-LV
(EUCTR)
06/05/201118/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
156EUCTR2009-017978-21-AT
(EUCTR)
05/05/201131/03/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
157EUCTR2009-017978-21-EE
(EUCTR)
21/04/201113/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
158EUCTR2011-000770-60-IT
(EUCTR)
12/04/201101/09/2011An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - NDAn open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - ND approximately 600 patients with relapsing-remitting MS for whom no suitable therapy exists i.e. where existing therapies have failed.
MedDRA version: 14.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: fingolimod
Product Code: FTY720D
INN or Proposed INN: other nervous system drugs
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
600Italy
159NCT01305837
(ClinicalTrials.gov)
April 201128/2/2011Cyclic Oral Methylprednisolone Trial in Multiple SclerosisCyclic Oral Methylprednisolone Trial in Multiple SclerosisProgressive Multiple SclerosisDrug: methylprednisoloneRigshospitalet, DenmarkNULLCompleted18 Years65 YearsBoth30Phase 2Denmark
160NCT01332019
(ClinicalTrials.gov)
April 201124/3/2011Long-Term Safety and Efficacy Study of Peginterferon Beta-1aA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: peginterferon beta-1aBiogenNULLCompleted18 Years65 YearsAll1077Phase 3United States;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Estonia;France;Georgia;Germany;Greece;India;Latvia;Mexico;Netherlands;New Zealand;Peru;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
161NCT01407211
(ClinicalTrials.gov)
April 201114/2/2011Impact of Vitamin A on Gene Expression, in Multiple Sclerosis PatientThe Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis PatientsRelapsing Remitting Multiple SclerosisDietary Supplement: vitamin ATehran University of Medical SciencesNULLEnrolling by invitation20 Years45 YearsBoth30Phase 4Iran, Islamic Republic of
162EUCTR2010-023560-40-SE
(EUCTR)
23/03/201121/12/2010Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed.Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST Relapsing-remitting multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Sendoxan
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Trade Name: Thymoglobuline
Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN
Trade Name: Neupogen
Trade Name: Solu-Medrol
Uppsala l?ns landstingNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120United States;Canada;Brazil;Sweden
163EUCTR2010-023021-38-SE
(EUCTR)
23/02/201126/11/2010Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSSwitch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS Relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate
MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Västerbottens läns landstingNULLNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
164EUCTR2009-017978-21-BG
(EUCTR)
08/02/201111/09/2015Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
165EUCTR2009-017978-21-DE
(EUCTR)
20/12/201022/11/2010Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
166NCT01181115
(ClinicalTrials.gov)
April 20105/8/2010Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)An Open-Label Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Avonex (Interferon Beta-1a) in Chinese Subjects With Relapsing Multiple SclerosisMultiple SclerosisDrug: AvonexBiogen IdecNULLCompleted18 Years55 YearsBoth60Phase 3China
167NCT01071512
(ClinicalTrials.gov)
April 201017/2/2010Tysabri Effects on Cognition and Neurodegeneration in Multiple SclerosisTysabri Effects on Cognition and Neurodegeneration in Multiple SclerosisMultiple SclerosisDrug: TysabriUniversity of ChicagoBiogenCompleted18 Years60 YearsAll20N/AUnited States
168NCT01077466
(ClinicalTrials.gov)
March 201026/2/2010Natalizumab Treatment of Progressive Multiple SclerosisNatalizumab Treatment of Progressive Multiple SclerosisPrimary Progressive Multiple Sclerosis;Secondary Progressive Multiple SclerosisDrug: NatalizumabRigshospitalet, DenmarkCopenhagen University Hospital, Hvidovre;Biogen Idec;University of Copenhagen;Signifikans ApSCompleted19 Years55 YearsBoth24Phase 2Denmark
169NCT01097668
(ClinicalTrials.gov)
March 201031/3/2010ATX-MS-1467 in Patients With Relapsing Forms of Multiple SclerosisSAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS).Relapsing Remitting Multiple SclerosisBiological: ATX-MS-1467Apitope Technology (Bristol) Ltd.Aptiv Solutions;ClinStar, LLCCompleted18 Years55 YearsAll43Phase 1Russian Federation;United Kingdom
170EUCTR2009-012431-15-CZ
(EUCTR)
21/01/201002/12/2009Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání.Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®.Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání.Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®. Studie se zabývá lécbou hyperaktivního neurogeního detruzoru u pacientu, kterí trpí príznaky hyperaktivního mocového mechýre jako dusledek spinálního poranení nebo roztroušené sklerózy. K lécbe se pužívá botulinumotoxin. Ve studii se porovnávaní dve ruzné formy aplikace studjiního léku.Trade Name: Botox
Other descriptive name: BOTULINUM TOXIN TYPE A
Krajská nemocnice Liberec, a.s.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Czech Republic
171NCT00904826
(ClinicalTrials.gov)
April 200918/5/2009An Open Label Study of the Effects of Eculizumab in Neuromyelitis OpticaAn Open Label Study of the Effects of Eculizumab in Neuromyelitis OpticaNeuromyelitis Optica;Devic's DiseaseDrug: EculizumabMayo ClinicAlexion PharmaceuticalsCompleted18 YearsN/AAll14Phase 1/Phase 2United States
172NCT00881205
(ClinicalTrials.gov)
April 200914/4/2009Rivastigmine in Multiple Sclerosis Patients With Cognitive ImpairmentA 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Rivastigmine Patch (10 cm²) on Cognitive Deficits in Patients With Multiple Sclerosis, Followed by a 1-year Open-label Treatment PhaseMultiple Sclerosis;Cognitive ImpairmentDrug: Rivastigmine transdermal patch;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years65 YearsAll86Phase 4Germany
173NCT00883337
(ClinicalTrials.gov)
April 200916/4/2009A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension PeriodMultiple SclerosisDrug: Interferon ß-1a;Drug: TeriflunomideSanofiNULLCompleted18 YearsN/AAll324Phase 3Belgium;Canada;Czech Republic;France;Germany;Greece;Hungary;Italy;Poland;Spain;Switzerland;Tunisia;United Kingdom
174NCT00882999
(ClinicalTrials.gov)
April 200916/4/2009A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: LY2127399;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 Years64 YearsAll245Phase 2United States;Bulgaria;Czechia;France;Germany;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;Belgium;Canada;Czech Republic;Denmark;Finland;Switzerland
175NCT00764413
(ClinicalTrials.gov)
April 20091/10/2008Chronotherapy in Acute Multiple Sclerosis (MS) AttackTreatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?Multiple SclerosisDrug: methylprednisolone;Drug: Sodium chloridSykehuset Innlandet HFNULLTerminated18 YearsN/ABoth57N/ANorway
176NCT00914290
(ClinicalTrials.gov)
April 20092/6/2009A Study With IPX056 in Subjects With Spasticity Associated With Multiple SclerosisA Study With IPX056 in Subjects With Spasticity Associated With Multiple SclerosisSpasticity;Multiple SclerosisDrug: IPX056;Drug: Baclofen IR;Drug: Placebo IPX056;Drug: Placebo IRImpax Laboratories, LLCNULLCompleted18 YearsN/AAll23Phase 2United States
177EUCTR2008-004174-40-FR
(EUCTR)
06/03/200925/11/2008Imagerie de la démyélinisation dans la sclérose en plaques : une étude en tomographie à émission de positons (TEP) avec le 11C-2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (11C-PIB) - SHADOWTEPImagerie de la démyélinisation dans la sclérose en plaques : une étude en tomographie à émission de positons (TEP) avec le 11C-2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (11C-PIB) - SHADOWTEP Groupe I: volontaires sainsGroupe II: patients avec une sclérose en plaques d'évolution rémittente .
MedDRA version: 8.1;Level: PT;Classification code 10012300;Term: Demyelinating disease (excl multiple sclerosis)
Product Name: 11C-PIB
INN or Proposed INN: 11C-PIB
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
178EUCTR2007-000381-20-BG
(EUCTR)
28/10/200820/10/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
179EUCTR2007-000381-20-GR
(EUCTR)
09/09/200801/04/2008A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Czech Republic;Denmark;Estonia;Greece;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom
180EUCTR2007-000381-20-NL
(EUCTR)
29/08/200801/02/2008A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece
181EUCTR2007-006338-32-ES
(EUCTR)
16/07/200828/03/2008Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosisEstudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis Esclerosis Múltiple Recurrente-remitente Relapsing remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMab 2H7
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Hoffman La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2France;Czech Republic;Slovakia;Finland;Belgium;Spain;Denmark;Bulgaria;Netherlands;Germany;Italy;United Kingdom
182EUCTR2007-000381-20-LT
(EUCTR)
15/07/200806/06/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
183JPRN-UMIN000002725
2008/07/0122/11/2009Efficacy of ramatroban in multiple sclerosis patientsEfficacy of ramatroban in multiple sclerosis patients - Efficacy of ramatroban Multiple sclerosisAddition of ramatroban to conventional MS therapyIou hospitalNULLComplete: follow-up completeNot applicableNot applicableMale and Female5Not selectedJapan
184EUCTR2007-000381-20-LV
(EUCTR)
29/05/200812/05/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany
185EUCTR2007-000381-20-EE
(EUCTR)
19/05/200828/12/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
186EUCTR2007-005363-10-FR
(EUCTR)
13/05/200811/12/2007Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CISEtude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CIS 1. Multiple Sclerosis2. Clinically isolated syndromes (at high risk to develop Multiple Sclerosis)
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive
MedDRA version: 9.1;Classification code 10028246;Term: Multiple sclerosis aggravated
MedDRA version: 9.1;Classification code 10028247;Term: Multiple sclerosis like syndrome
MedDRA version: 9.1;Classification code 10028248;Term: Multiple sclerosis-like syndrome
MedDRA version: 9.1;Classification code 10048393;Term: Multiple sclerosis relapse
MedDRA version: 9.1;Classification code 10053395;Term: Progressive multiple sclerosis
MedDRA version: 9.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
MedDRA version: 9.1;Classification code 10063401;Term: Primary progressive multiple sclerosis
MedDRA version: 9.1;Classification code 10064137;Term: Progression of multiple sclerosis
MedDRA version: 9.1;Level: PT;Term: Secondary progressive multiple sclerosis
Product Code: SH U 555 CC.H.U. de RENNESNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
187EUCTR2007-000381-20-PT
(EUCTR)
28/04/200815/01/2008A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece
188NCT00605215
(ClinicalTrials.gov)
April 24, 20088/1/2008BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon ß-1a (Avonex®)A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon ß-1a (Avonex®) in a Rater-blinded DesignMultiple SclerosisDrug: Laquinimod;Drug: Placebo;Drug: Avonex®Teva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 Years55 YearsAll1331Phase 3United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Israel;Italy;Lithuania;North Macedonia;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;Latvia;Macedonia, The Former Yugoslav Republic of;Montenegro;Turkey
189EUCTR2007-000381-20-CZ
(EUCTR)
23/04/200814/12/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
190EUCTR2007-000381-20-DK
(EUCTR)
15/04/200805/03/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Australia;United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany
191NCT00642902
(ClinicalTrials.gov)
April 200821/3/2008A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment CourseRelapsing Multiple SclerosisDrug: Atacicept;Drug: Placebo matched to ataciceptEMD SeronoNULLTerminated18 Years60 YearsAll255Phase 2United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom
192NCT00670449
(ClinicalTrials.gov)
April 200828/4/2008An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple SclerosisAn Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: FingolimodNovartisMitsubishi Tanabe Pharma CorporationCompleted18 Years60 YearsAll143Phase 2Japan
193NCT01414816
(ClinicalTrials.gov)
April 200813/7/2011Betaferon® Regulatory Post-Marketing SurveillanceBetaferon® Regulatory Post-Marketing SurveillanceMultiple Sclerosis;Clinically Isolated SystemDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted12 YearsN/ABoth355N/AKorea, Republic of
194EUCTR2007-000381-20-DE
(EUCTR)
17/03/200828/02/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany
195EUCTR2007-002179-15-FR
(EUCTR)
04/03/200822/11/2007Etude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques - CORTICOFLASHEtude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques - CORTICOFLASH Méthylprednisolone administrée aux patients et contrôles à la dose de 1g/j pendant 3 jours, comme prescrit habituellement dans le cadre de leur pathologie.
MedDRA version: 8.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Methylprednisolone
Product Name: Methylprednisolone
INN or Proposed INN: Methylprednisolone
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
196EUCTR2007-000381-20-GB
(EUCTR)
04/03/200826/11/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Latvia;Netherlands;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany
197EUCTR2007-000381-20-BE
(EUCTR)
21/01/200820/12/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany
198EUCTR2006-001152-12-HU
(EUCTR)
09/01/200809/10/2007Not applicableAn international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. - TOPIC Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
600United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany
199EUCTR2007-000381-20-AT
(EUCTR)
30/12/200703/01/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
200EUCTR2007-000381-20-FR
(EUCTR)
14/12/200717/10/2007A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MSA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MS Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Portugal;Estonia;Greece;Finland;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Bulgaria;Latvia;Netherlands;Germany
201EUCTR2006-002982-38-LT
(EUCTR)
30/11/200701/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
202EUCTR2007-000381-20-FI
(EUCTR)
16/11/200715/10/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
203EUCTR2006-003037-32-LT
(EUCTR)
11/09/200727/11/2006A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Estonia;Spain;Italy;Lithuania
204EUCTR2006-002633-20-LT
(EUCTR)
07/09/200705/07/2007Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
350Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania
205EUCTR2006-002633-20-FR
(EUCTR)
04/07/200711/09/2006Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Finland;Spain;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy
206EUCTR2006-005270-47-GR
(EUCTR)
03/07/200718/06/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
207EUCTR2006-007057-42-DK
(EUCTR)
25/06/200714/05/2007An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrastAn open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast relapsing forms of multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
Product Name: firategrast (USAN approved name)
Product Code: SB-683699
Other descriptive name: firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
45Czech Republic;Denmark;Sweden
208EUCTR2006-002982-38-PT
(EUCTR)
29/05/200722/02/2007A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
209EUCTR2006-007057-42-BE
(EUCTR)
29/05/200714/02/2007An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrastAn open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast relapsing forms of multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
Product Name: firategrast (USAN approved name)
Product Code: SB-683699
Other descriptive name: firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
45Czech Republic;Belgium;Denmark;Sweden
210EUCTR2006-005270-47-FR
(EUCTR)
22/05/200723/01/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Schering AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
211EUCTR2006-005270-47-SI
(EUCTR)
16/05/200704/04/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering PharmaNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
212EUCTR2006-002982-38-GR
(EUCTR)
08/05/200729/12/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
213EUCTR2006-007057-42-CZ
(EUCTR)
03/05/200716/03/2007An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrastAn open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast relapsing forms of multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
Product Name: firategrast (USAN approved name)
Product Code: SB-683699
Other descriptive name: firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Czech Republic;Belgium;Denmark;Sweden
214EUCTR2006-007057-42-SE
(EUCTR)
02/05/200715/02/2007An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrastAn open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast relapsing forms of multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
Product Name: firategrast (USAN approved name)
Product Code: SB-683699
Other descriptive name: firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
45Czech Republic;Denmark;Sweden
215EUCTR2006-005270-47-LV
(EUCTR)
02/05/200703/04/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
216EUCTR2006-005270-47-FI
(EUCTR)
23/04/200719/12/2006 International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Schering AGNULLNot Recruiting Female: yes
Male: yes
1880 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
217NCT00548769
(ClinicalTrials.gov)
April 21, 200723/10/2007Firategrast (SB683699) Surface Area Study in Multiple Sclerosis PatientsAn Open-label, Randomised, Four Period Crossover Study to Investigate the Relative Pharmacokinetic Profiles of Tablets From Three Batches of Firategrast With Different Surface Areas and Two Different Tablet Formulations Containing the Same Batch of Firategrast, Given as Single 900mg Doses to Male and Female Subjects With a Diagnosis of Multiple SclerosisMultiple SclerosisDrug: Formulation A;Drug: Formulation B;Drug: Formulation C;Drug: Formulation DGlaxoSmithKlineNULLCompleted18 Years65 YearsAll37Phase 1Czechia;Germany;Poland;Czech Republic
218EUCTR2006-005270-47-HU
(EUCTR)
16/04/200709/03/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering PharmaNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
219EUCTR2006-003037-32-DE
(EUCTR)
13/04/200701/12/2006A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Estonia;Spain;Italy;Lithuania
220EUCTR2006-005270-47-BE
(EUCTR)
12/04/200722/12/2006International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
221EUCTR2006-005270-47-NL
(EUCTR)
02/04/200718/04/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Schering AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
222NCT00475865
(ClinicalTrials.gov)
April 200718/5/2007Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple SclerosisA Randomized, Multinational, Double-blind, Placebo-controlled, Parallel-group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple SclerosisMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Glatiramer Acetate (GA)SanofiNULLCompleted18 Years55 YearsAll123Phase 2United States;Austria;Canada;Germany;Italy;United Kingdom
223NCT00468182
(ClinicalTrials.gov)
April 200730/4/2007Modulation of Plasmacytoid Dendritic Cell Function in Multiple SclerosisModulation of Plasmacytoid Dendritic Cell Function in Multiple SclerosisMultiple SclerosisDrug: Interferon-beta 1b (Betaseron)Rutgers, The State University of New JerseyBayerCompleted18 Years60 YearsBoth24United States
224NCT00472797
(ClinicalTrials.gov)
April 200710/5/2007Rebif New Formulation (RNF) Quality of Life (QOL) StudyA Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF)Relapsing Multiple SclerosisDrug: Rebif New Formulation Non Titrated;Drug: Rebif New Formulation TitratedEMD SeronoNULLCompleted18 Years60 YearsAll232Phase 3United States
225EUCTR2006-002633-20-IT
(EUCTR)
26/03/200705/02/2007Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 - 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 - 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Firategrast
Product Code: SB683699
INN or Proposed INN: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
INN or Proposed INN: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
350France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy
226EUCTR2006-002982-38-DE
(EUCTR)
16/03/200710/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
227EUCTR2006-002982-38-EE
(EUCTR)
15/03/200731/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaANULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
228EUCTR2006-003037-32-EE
(EUCTR)
06/03/200726/01/2007A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Estonia;Spain;Italy;Lithuania
229EUCTR2006-005270-47-SE
(EUCTR)
28/02/200702/02/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer AB, Bayer Health Care, Bayer Schering PharmaNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
230EUCTR2006-005270-47-AT
(EUCTR)
22/02/200731/01/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Schering AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Germany;Latvia;Netherlands;Sweden
231EUCTR2006-003366-33-ES
(EUCTR)
13/02/200703/03/2010Estudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple ActivaEstudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple Activa Pacientes con esclerosis múltiple activa
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: not applicable
Product Name: Interferon beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
Trade Name: not applicable
Product Name: cladribina oral
Product Code: not applicable
INN or Proposed INN: cladribine
Serono International, S.A.NULLNot RecruitingFemale: yes
Male: yes
290Phase 2Spain;Italy
232EUCTR2006-003037-32-ES
(EUCTR)
09/02/200710/03/2010Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Estonia;Spain;Lithuania;Germany;Italy
233EUCTR2006-002633-20-GB
(EUCTR)
25/01/200710/02/2012Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Finland;Spain;Lithuania;Austria;Germany;Netherlands;Italy;United Kingdom
234EUCTR2006-002982-38-SK
(EUCTR)
12/01/200706/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaANULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
235EUCTR2006-002982-38-FR
(EUCTR)
05/01/200724/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Serono International SANULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
236NCT03135327
(ClinicalTrials.gov)
January 1, 200724/4/2017Clinical Applications of Advanced Ophthalmic ImagingClinical Applications of Advanced Ophthalmic ImagingMultiple Sclerosis;Dry Eye Syndromes;Diabetic Retinopathy;Presbyopia;Myopia;DementiaDietary Supplement: OcufolinUniversity of MiamiNULLRecruiting18 Years99 YearsAll5000N/AUnited States
237EUCTR2006-002982-38-DK
(EUCTR)
20/12/200630/11/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Denmark;Belgium;Estonia;Spain;Greece
238EUCTR2006-002982-38-FI
(EUCTR)
19/12/200619/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
239EUCTR2006-002633-20-FI
(EUCTR)
05/12/200604/09/2006Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
350Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania
240EUCTR2006-002982-38-AT
(EUCTR)
04/12/200629/09/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
241EUCTR2006-002633-20-ES
(EUCTR)
01/12/200613/04/2012Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrenteEstudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente Esclerosis múltiple remitente-recurrente
MedDRA version: 14.1;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]
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline S.ANULLNot RecruitingFemale: yes
Male: yes
350Phase 2Finland;Spain;Lithuania;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Norway;New Zealand
242EUCTR2006-002982-38-BE
(EUCTR)
29/11/200614/09/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A.-Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
243EUCTR2006-000606-23-ES
(EUCTR)
23/11/200615/03/2012?Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phasePost-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase - PASS-PD del escalado de dosis de Rebif Not applicalbe
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rebif 22 y 44 mcg
Product Name: Interferon-beta-1a
Other descriptive name: INTERFERON BETA-1A
Merck, S.L.NULLNot RecruitingFemale: yes
Male: yes
100Phase 4Spain
244EUCTR2006-002633-20-NL
(EUCTR)
17/11/200610/08/2006Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
350Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania
245EUCTR2006-002982-38-CZ
(EUCTR)
03/11/200615/09/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
246EUCTR2006-002633-20-DE
(EUCTR)
25/10/200623/08/2006Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
350France;Finland;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy
247EUCTR2006-001161-42-SE
(EUCTR)
17/10/200629/05/2006Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicableMulticentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicable Multiple sclerosis (MS)Product Name: DACLIZUMAB HYP
Other descriptive name: Daclizumab HYP (DAC HYP)
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
232Hungary;Germany;United Kingdom;Sweden
248EUCTR2004-002567-24-GB
(EUCTR)
09/10/200622/02/2005A Phase 2a Magnetic Resonance Study of the Safety and Efficacy of MLN1202 in Patients with Multiple Sclerosis - Not applicableA Phase 2a Magnetic Resonance Study of the Safety and Efficacy of MLN1202 in Patients with Multiple Sclerosis - Not applicable The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS).
MedDRA version: 8.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: MLN1202
Product Code: MLN1202
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Czech Republic;United Kingdom
249EUCTR2006-002633-20-AT
(EUCTR)
05/10/200614/09/2006Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
350Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania
250EUCTR2005-005751-18-GB
(EUCTR)
07/09/200617/02/2006A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy StudyA multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK.Trade Name: Rebif 44
Product Name: Rebif 44
Product Code: Interferon beta 1a
INN or Proposed INN: Interferon beta 1a
Trade Name: Rebif 22
Product Name: Rebif 22
Product Code: Interferon beta 1a
INN or Proposed INN: Interferon beta 1a
Product Name: Betaferon 500mcg
Product Code: Betaferon 500mcg
INN or Proposed INN: Interferon beta 1b
UCL Biomedicine R&D UnitNULLNot RecruitingFemale: yes
Male: yes
100United Kingdom
251NCT00261326
(ClinicalTrials.gov)
September 20062/12/2005Simvastatin Treatment of Patients With Acute Optic NeuritisSimvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III TrialOptic Neuritis;Multiple SclerosisDrug: simvastatin;Drug: placeboGlostrup University Hospital, CopenhagenAlpharma ApSActive, not recruiting18 Years59 YearsBoth64Phase 3Denmark
252EUCTR2004-005148-28-LT
(EUCTR)
18/07/200602/05/2006A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
253EUCTR2004-005148-28-LV
(EUCTR)
05/06/200611/01/2007A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
254EUCTR2004-005148-28-SK
(EUCTR)
01/06/200625/04/2006A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Czech Republic;Estonia;Slovakia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom
255EUCTR2004-005148-28-AT
(EUCTR)
22/11/200518/10/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Czech Republic;Estonia;Finland;Lithuania;Denmark;Austria;Latvia;Germany;Italy;United Kingdom
256EUCTR2004-005148-28-DE
(EUCTR)
17/11/200516/05/2006A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International, a branch of Laboratories Serono S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Czech Republic;United Kingdom;Germany;Denmark;Estonia;Italy;Latvia;Lithuania
257NCT00273364
(ClinicalTrials.gov)
November 16, 20055/1/2006Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized StudyHematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized StudyMultiple SclerosisProcedure: Hematopoietic Stem Cell Therapy;Drug: Standard treatment with a conventional drugNorthwestern UniversityUppsala University;Sheffield Teaching Hospitals NHS Foundation Trust;University of Sao PauloCompleted18 Years55 YearsAll110Phase 2United States
258EUCTR2005-001008-37-SE
(EUCTR)
01/11/200521/03/2005Analysis of the antibody level against interferon beta before and after increase of dose in MS therapy - Interferon beta dose and antibodyAnalysis of the antibody level against interferon beta before and after increase of dose in MS therapy - Interferon beta dose and antibody Multiple sclerosisTrade Name: Rebif®
Product Name: Rebif®
Product Code: Not applicable
INN or Proposed INN: Interferon beta-1a
Sahlgrenska University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Sweden
259NCT00313976
(ClinicalTrials.gov)
November 200511/4/2006Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)BayerNULLWithdrawn18 YearsN/ABoth0Phase 3Denmark;Sweden
260EUCTR2004-005148-28-GB
(EUCTR)
28/10/200520/04/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International, a branch of Laboratoires Serono S.A.NULLNot Recruiting Female: yes
Male: yes
1290 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Estonia;Slovakia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom
261EUCTR2004-005148-28-EE
(EUCTR)
09/09/200531/05/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
262EUCTR2004-002567-24-HU
(EUCTR)
19/07/200506/04/2005A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not applicableA Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not applicable The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS).Product Name: MLN1202
Product Code: MLN1202
INN or Proposed INN: Not yet available
Other descriptive name: Not yet available
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;United Kingdom;Czech Republic
263EUCTR2004-005148-28-CZ
(EUCTR)
14/07/200515/06/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;United Kingdom;Czech Republic;Denmark;Estonia;Italy;Latvia;Lithuania
264EUCTR2004-005148-28-BE
(EUCTR)
14/06/200505/07/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Czech Republic;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom
265EUCTR2004-005148-28-DK
(EUCTR)
02/06/200509/05/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
266NCT00202397
(ClinicalTrials.gov)
June 200512/9/2005Effect of Riluzole as a Symptomatic Approach in Patients With Chronic Cerebellar AtaxiaPhase 2 Study of Riluzole Effects on Patients With Chronic Cerebellar AtaxiaHereditary Ataxia;Multiple Sclerosis;Cerebellar AtaxiaDrug: Riluzole;Other: placeboS. Andrea HospitalNULLCompleted18 Years80 YearsBoth40Phase 2Italy
267EUCTR2004-005148-28-FI
(EUCTR)
26/05/200518/04/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
268EUCTR2004-002567-24-CZ
(EUCTR)
04/04/200504/02/2005A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not appilcableA Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not appilcable The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS).Product Name: MLN1202
Product Code: MLN1202
INN or Proposed INN: Not yet available
Other descriptive name: Not yet available
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;United Kingdom;Czech Republic
269NCT00668343
(ClinicalTrials.gov)
April 200527/4/2008Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to PlaceboRelapsing Remitting Multiple SclerosisDrug: simvastatin;Drug: placeboTehran University of Medical SciencesNULLCompleted15 Years60 YearsBoth80Phase 3Iran, Islamic Republic of
270NCT00109161
(ClinicalTrials.gov)
April 200522/4/2005Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple SclerosisA Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: Daclizumab (Anti-CD25 Humanized Monoclonal Antibody)PDL BioPharma, Inc.NULLCompleted18 Years55 YearsBoth270Phase 2United States;Canada
271NCT00213135
(ClinicalTrials.gov)
April 200513/9/2005A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)Multiple Sclerosis, Relapsing-RemittingDrug: Cladribine 5.25 mg/kg;Drug: Cladribine 3.5 mg/kg;Other: PlaceboEMD SeronoNULLCompleted18 Years65 YearsAll1326Phase 3Canada;Switzerland
272EUCTR2004-003799-13-GB
(EUCTR)
16/03/200518/07/2005A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot Recruiting Female: yes
Male: yes
230 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden
273EUCTR2004-003799-13-LT
(EUCTR)
08/03/200527/12/2004A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3United Kingdom;Spain;Ireland;Sweden;Lithuania
274EUCTR2004-003799-13-DK
(EUCTR)
24/02/200518/01/2005A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden
275EUCTR2004-004130-14-AT
(EUCTR)
17/02/200513/01/2005A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week).A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week). Male and female subjects with relapsing multiple sclerosis previously treated with interferon beta-1a (22 mcg or 44 mcg, SC three times a week).Product Name: Natalizumab
Product Code: Not Applicable
INN or Proposed INN: natalizumab
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: Interferon beta-1a
Biogen Idec GmbHNULLNot RecruitingFemale: yes
Male: yes
1050Austria
276EUCTR2004-003799-13-ES
(EUCTR)
17/02/200504/11/2005A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden
277EUCTR2004-003799-13-SE
(EUCTR)
03/02/200523/12/2004A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3United Kingdom;Spain;Ireland;Lithuania;Sweden
278EUCTR2004-000337-12-HU
(EUCTR)
23/07/200429/09/2004A multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone StudyA multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone Study MS with 2 or more relapses within the last 2 years
MedDRA version: 7.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Rebif
Product Code: Not applicable
INN or Proposed INN: Interferon beta-1a
Other descriptive name: Recombinant human interferon beta
Trade Name: Rebif
Product Name: Rebif
Product Code: Not applicable
INN or Proposed INN: Interferon beta-1a
Other descriptive name: Recombinant human interferon beta
Serono International SANULLNot RecruitingFemale: yes
Male: yes
400Phase 4Hungary
279NCT00202995
(ClinicalTrials.gov)
July 200413/9/2005Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMSA Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis PatientsRelapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate;Drug: Betaseron;Drug: RebifTeva Pharmaceutical IndustriesNULLTerminated18 Years50 YearsBoth91Phase 4United States;Canada
280NCT00682929
(ClinicalTrials.gov)
April 14, 200419/5/2008Cannabis for Spasticity in Multiple SclerosisCannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled StudyMultiple SclerosisDrug: Inhaled Cannabis;Drug: Oral THC;Drug: Oral Placebo;Drug: Inhaled placeboUniversity of California, DavisNational Multiple Sclerosis SocietyTerminated21 YearsN/AAll41Phase 1/Phase 2United States
281NCT00300716
(ClinicalTrials.gov)
April 20048/3/2006Trial of Memantine for Cognitive Impairment in Multiple SclerosisDouble Blind Placebo Controlled Pilot Trial of Memantine for Cognitive Impairment in Multiple SclerosisMultiple Sclerosis;Cognition DisordersDrug: MemantineOregon Health and Science UniversityForest Laboratories;University of Southern California;University of Texas Southwestern Medical Center;MS-Hub SeattleCompleted18 Years65 YearsAll82Phase 2/Phase 3United States
282NCT01233245
(ClinicalTrials.gov)
April 200414/10/2010BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus ProgramBetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus ProgramRelapsing Remitting MS (RRMS);Secondary Progressive MS (SPMS)Drug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 YearsN/ABoth1077N/ACzech Republic;France;Germany;Iran, Islamic Republic of;Israel;Italy;Jordan;Korea, Republic of;Lebanon;Netherlands;Portugal;Saudi Arabia;Spain;Taiwan;Turkey
283NCT00086671
(ClinicalTrials.gov)
April 20047/7/2004Safety and Effectiveness of Two Doses of ABT-874 as Compared to Placebo in Subjects With Multiple Sclerosis (MS)A 24-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Finding, Safety, Tolerability, and Efficacy Study of the Human Anti-IL-12 Antibody ABT-874 in Subjects With Multiple Sclerosis With a 24-Week Double-Blind, Active Extension PhaseMultiple SclerosisDrug: ABT-874/Human monoclonal antibody against IL-12;Drug: PlaceboAbbVie (prior sponsor, Abbott)NULLCompleted18 Years60 YearsBoth215Phase 2United States;Canada;Germany;Netherlands;United Kingdom
284NCT00217295
(ClinicalTrials.gov)
April 200414/9/2005A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple SclerosisA Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis.Multiple SclerosisDrug: Avonex and TopamaxMultiple Sclerosis InstituteNULLRecruiting18 Years55 YearsBoth30Phase 2United States
285NCT00202982
(ClinicalTrials.gov)
August 200312/9/2005A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved DoseA Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis PatientsRelapse-Remitting Multiple SclerosisDrug: glatiramer acetate 20 mg;Drug: glatiramer acetate 40 mgTeva Pharmaceutical IndustriesNULLCompleted18 Years50 YearsBoth90Phase 2United States
286NCT00053417
(ClinicalTrials.gov)
February 200329/1/2003Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple SclerosisDouble-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple SclerosisMultiple SclerosisDrug: Placebo;Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP);Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP);Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP)Acorda TherapeuticsNULLCompleted18 Years70 YearsAll206Phase 2United States;Canada
287NCT00298662
(ClinicalTrials.gov)
February 20032/3/2006Combination Therapy of Betaseron-Prograf in Multiple SclerosisA Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying AgentsMultiple SclerosisDrug: Interferon beta-1b and TacrolimusClinique de sclérose en plaques et neuromusculaire de l'OutaouaisNULLActive, not recruiting18 Years55 YearsBoth30Phase 2Canada
288NCT00405353
(ClinicalTrials.gov)
April 200228/11/2006Testosterone Treatment for Multiple SclerosisTestosterone Treatment for Multiple Sclerosis: A Preliminary TrialMultiple SclerosisDrug: Androgel 10 grams of gel containing 100 mg of testosteroneUniversity of California, Los AngelesNational Multiple Sclerosis SocietyCompleted18 Years65 YearsMale10Phase 1/Phase 2United States
289NCT00017628
(ClinicalTrials.gov)
April 20016/6/2001Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple SclerosisMultiple SclerosisDrug: cyclophosphamide;Drug: filgrastim;Drug: methylprednisolone;Procedure: Autologous Stem Cell TransplantationNorthwestern Memorial HospitalNULLCompletedN/A59 YearsBoth20Phase 1United States
290NCT01487096
(ClinicalTrials.gov)
April 20015/12/2011Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With RelapsesA Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With RelapsesMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (placebo for teriflunomide)SanofiNULLCompleted18 Years65 YearsBoth179Phase 2Canada;France
291NCT00006060
(ClinicalTrials.gov)
April 19995/7/2000Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple SclerosisMultiple SclerosisDrug: standard gadolinium contrastNational Center for Research Resources (NCRR)University of PennsylvaniaRecruiting20 Years70 YearsBoth100N/AUnited States
292NCT00040482
(ClinicalTrials.gov)
April 199926/6/2002High Dose Chemo/Radiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple SclerosisIntensive Immunosuppression Followed by Rescue With CD34 Selected, T Cell Depleted, Leukopheresis Products in Patients With Multiple SclerosisMultiple SclerosisDrug: Cyclophosphamide;Drug: ATG;Drug: MESNA;Procedure: Radiation therapyBaylor College of MedicineThe Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of MedicineCompleted18 Years60 YearsAll10Phase 2United States
293EUCTR2004-003799-13-IE
(EUCTR)
13/01/2005A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot Recruiting Female: yes
Male: yes
230 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden
294JPRN-JapicCTI-050031
06/09/2005Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval)Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval) [Spinal cord Origin] Spinal cord Injury, Multiple sclerosis, Spinocerebellar degeneration, Circulatory disorder of the spinal, Ossification of the posterior longitudinal ligament [Cerebral Origin] Cerebral palsy, Traumatic head injuryIntervention name : Baclofen
Dosage And administration of the intervention : Intertheacal injection
DAIICHI SANKYO COMPANY, LIMITEDNULLBOTHPhase 4NULL
295EUCTR2006-005270-47-DE
(EUCTR)
09/02/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering PharmaNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece