BIIB054 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 9 |
6. パーキンソン病
臨床試験数 : 2,307 / 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
| 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 | NCT03716570 (ClinicalTrials.gov) | March 12, 2019 | 22/10/2018 | A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease | A Multicenter, Blinded, Placebo-Controlled, Randomized, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Subjects With Parkinson's Disease | Parkinson's Disease | Drug: BIIB054;Drug: Placebo | Biogen | NULL | Terminated | 40 Years | 80 Years | All | 24 | Phase 1 | Japan |
| 2 | EUCTR2016-004610-95-DE (EUCTR) | 01/10/2018 | 27/02/2018 | Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 357 | Phase 2 | France;United States;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2016-004610-95-FR (EUCTR) | 08/08/2018 | 01/03/2018 | Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 311 | Phase 2 | United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy;Sweden | ||
| 4 | EUCTR2016-004610-95-ES (EUCTR) | 18/05/2018 | 07/03/2018 | Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 311 | Phase 2 | United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2016-004610-95-GB (EUCTR) | 01/05/2018 | 27/12/2017 | Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 357 | Phase 2 | United States;France;Canada;Spain;Austria;Israel;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2016-004610-95-AT (EUCTR) | 23/03/2018 | 04/01/2018 | Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 357 | Phase 2 | United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy | ||
| 7 | EUCTR2016-004610-95-IT (EUCTR) | 22/03/2018 | 14/01/2021 | Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson¿s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson¿s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: nd Product Code: [BIIB054] INN or Proposed INN: HA 1A ANTICORPO MONOCLONALE UMANO CLASSE IGM | BIOGEN IDEC RESEARCH LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 311 | Phase 2 | France;United States;Canada;Spain;Austria;Australia;Israel;Germany;United Kingdom;Italy;Sweden | ||
| 8 | NCT03318523 (ClinicalTrials.gov) | January 10, 2018 | 19/10/2017 | Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: Placebo;Drug: BIIB054 | Biogen | NULL | Terminated | 40 Years | 80 Years | All | 357 | Phase 2 | United States;Austria;Canada;France;Germany;Israel;Italy;Spain;United Kingdom |
| 9 | NCT02459886 (ClinicalTrials.gov) | July 1, 2015 | 29/5/2015 | Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease | A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Single-Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB054 in Healthy Subjects and Subjects With Early Parkinson's Disease | Parkinson's Disease;Healthy | Drug: BIIB054;Drug: Placebo | Biogen | NULL | Completed | 40 Years | 80 Years | All | 66 | Phase 1 | United States |