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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02201849 (ClinicalTrials.gov) | July 2014 | 18/7/2014 | A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults | A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults | Multiple Sclerosis | Drug: Study Drug;Drug: Active Control;Drug: Placebo | Biogen | NULL | Completed | 18 Years | 55 Years | All | 104 | Phase 1 | United States |
| 2 | EUCTR2013-003126-83-DE (EUCTR) | 23/06/2014 | 17/02/2014 | Study 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United 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 | ||
| 3 | EUCTR2013-003126-83-GR (EUCTR) | 27/05/2014 | 25/02/2014 | Study 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United 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 | ||
| 4 | EUCTR2013-002351-15-ES (EUCTR) | 26/05/2014 | 25/02/2014 | Study 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | Serbia;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 | ||
| 5 | EUCTR2013-003126-83-ES (EUCTR) | 26/05/2014 | 05/03/2014 | Study 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | Serbia;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 | ||
| 6 | EUCTR2013-002351-15-BG (EUCTR) | 21/05/2014 | 20/02/2014 | Study 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United 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 | ||
| 7 | EUCTR2013-002351-15-HU (EUCTR) | 21/05/2014 | 21/02/2014 | Study 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United 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 | ||
| 8 | EUCTR2013-003126-83-HU (EUCTR) | 21/05/2014 | 21/02/2014 | Study 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United 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 | ||
| 9 | EUCTR2013-002351-15-PT (EUCTR) | 09/05/2014 | 25/02/2014 | Study 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United 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 | ||
| 10 | EUCTR2013-003126-83-BG (EUCTR) | 16/04/2014 | 20/02/2014 | Study 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 KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1176 | Phase 3 | United 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 | ||
| 11 | EUCTR2013-002351-15-AT (EUCTR) | 13/03/2014 | 28/02/2014 | Study 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United 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 | ||
| 12 | EUCTR2013-002351-15-EE (EUCTR) | 13/03/2014 | 18/02/2014 | Study 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United 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 | ||
| 13 | EUCTR2013-002351-15-LV (EUCTR) | 03/03/2014 | 20/02/2014 | Study 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United 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 | ||
| 14 | EUCTR2012-002470-31-LT (EUCTR) | 06/03/2013 | 05/09/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting 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 Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 15 | EUCTR2012-002470-31-BE (EUCTR) | 25/02/2013 | 22/10/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting 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 Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 16 | EUCTR2012-002470-31-BG (EUCTR) | 30/01/2013 | 03/01/2013 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting 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 Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden | ||
| 17 | EUCTR2012-002470-31-IT (EUCTR) | 21/01/2013 | 13/12/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebocontrolled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks 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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 Product Name: MT-1303 Product Code: MT-1303 Product Name: MT-1303 Product Code: MT-1303 | MITSUBISHI PHARMA CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Finland;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Bosnia and Herzegovina | ||
| 18 | EUCTR2012-002470-31-ES (EUCTR) | 16/01/2013 | 05/02/2013 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks 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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 19 | EUCTR2012-002470-31-FI (EUCTR) | 14/01/2013 | 02/10/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting 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 Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 20 | EUCTR2012-002470-31-PL (EUCTR) | 17/12/2012 | 21/12/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting 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 Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Turkey;Lithuania;Russian Federation;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 21 | EUCTR2012-002470-31-CZ (EUCTR) | 04/12/2012 | 11/09/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting 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 Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden | ||
| 22 | EUCTR2012-002470-31-HU (EUCTR) | 08/11/2012 | 25/09/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks 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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 23 | EUCTR2012-002470-31-GB (EUCTR) | 29/10/2012 | 03/09/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 15.0;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: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;United Kingdom;Switzerland;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina |