ALKS 8700 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 10 |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
| 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 | EUCTR2017-001294-16-DE (EUCTR) | 18/02/2019 | 07/11/2018 | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: N/A Product Code: ALKS 8700 Delayed Release (DR) INN or Proposed INN: Not available Other descriptive name: Diroximel fumarate Trade Name: Tecfidera® 120 mg Product Name: Tecfidera® 120 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera® 240 mg Product Name: Tecfidera® 240 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Alkermes, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Poland;Germany | ||
| 2 | EUCTR2017-001294-16-PL (EUCTR) | 22/09/2017 | 29/06/2017 | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: N/A Product Code: ALKS 8700 Delayed Release (DR) INN or Proposed INN: Not available Other descriptive name: Diroximel Fumarate (DRF) Trade Name: Tecfidera® 120 mg Product Name: Tecfidera® 120 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera® 240 mg Product Name: Tecfidera® 240 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Alkermes, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Poland;Germany | ||
| 3 | NCT03093324 (ClinicalTrials.gov) | March 15, 2017 | 16/3/2017 | A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2 | A Phase 3 Study in Subjects With Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | Relapsing Remitting Multiple Sclerosis | Drug: ALKS 8700;Drug: Dimethyl Fumarate | Biogen | Alkermes, Inc. | Completed | 18 Years | 65 Years | All | 506 | Phase 3 | United States;Germany;Poland |
| 4 | EUCTR2015-005160-41-DE (EUCTR) | 27/07/2016 | 04/03/2016 | an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: N/A Product Code: ALKS 8700 Delayed Release (DR) Capsule INN or Proposed INN: Not available Other descriptive name: ALKS 8700 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Canada;Spain;Poland;Belgium;Ukraine;Bulgaria;Russian Federation;Germany | ||
| 5 | EUCTR2015-005160-41-BG (EUCTR) | 27/06/2016 | 04/05/2016 | an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis - EVOLVE-MS-1 | Relapsing Remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: N/A Product Code: ALKS 8700 Delayed Release (DR) Capsule INN or Proposed INN: Not available Other descriptive name: ALKS 8700 | Alkermes, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Canada;Spain;Poland;Belgium;Ukraine;Russian Federation;Bulgaria;Germany | ||
| 6 | EUCTR2015-005160-41-PL (EUCTR) | 07/06/2016 | 13/04/2016 | an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis - EVOLVE-MS-1 | Relapsing Remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: N/A Product Code: ALKS 8700 Delayed Release (DR) Capsule INN or Proposed INN: Not available Other descriptive name: ALKS 8700 | Alkermes, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Canada;Belgium;Spain;Poland;Ukraine;Russian Federation;Bulgaria;Germany | ||
| 7 | EUCTR2015-005160-41-ES (EUCTR) | 06/06/2016 | 20/04/2016 | an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis 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: N/A Product Code: ALKS 8700 Delayed Release (DR) Capsule INN or Proposed INN: Not available Other descriptive name: ALKS 8700 | Alkermes, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Serbia;Canada;Poland;Belgium;Spain;Ukraine;Russian Federation;Bulgaria;Germany | ||
| 8 | EUCTR2015-005160-41-BE (EUCTR) | 27/04/2016 | 07/03/2016 | an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: N/A Product Code: ALKS 8700 Delayed Release (DR) Capsule INN or Proposed INN: Not available Other descriptive name: ALKS 8700 | Alkermes, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Canada;Spain;Poland;Belgium;Ukraine;Russian Federation;Bulgaria;Germany | ||
| 9 | NCT02634307 (ClinicalTrials.gov) | December 10, 2015 | 16/12/2015 | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis | A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: ALKS 8700 | Biogen | Alkermes, Inc. | Completed | 18 Years | 65 Years | All | 1057 | Phase 3 | United States;Belgium;Bulgaria;Canada;Germany;Poland;Russian Federation;Serbia;Spain;Ukraine |
| 10 | 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 |