Prx002 (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 | 7 |
| 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 | EUCTR2017-000087-15-DE (EUCTR) | 21/12/2017 | 17/05/2017 | A Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants with Early Parkinson’s Disease with a 6 -Year all-Participants-on Treatment Extension (Pasadena) | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) | 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: aSyn Mab Product Code: RO7046015 INN or Proposed INN: N/A Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;France;Spain;Austria;Germany | ||
| 2 | EUCTR2017-000087-15-AT (EUCTR) | 17/08/2017 | 18/05/2017 | A Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab(PRX002) in Participants with Early Parkinson's Disease with A 6-Year all-Participants-on-Treatment Extension (Pasadena) | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) | 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: aSyn Mab Product Code: RO7046015 INN or Proposed INN: N/A Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | France;United States;Spain;Austria;Germany | ||
| 3 | EUCTR2017-000087-15-FR (EUCTR) | 27/07/2017 | 30/10/2017 | A Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with A 52-Week Blinded Extension (Pasadena) | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) | 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: aSyn Mab Product Code: RO7046015 INN or Proposed INN: N/A Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;France;Spain;Austria;Germany | ||
| 4 | EUCTR2017-000087-15-ES (EUCTR) | 26/07/2017 | 08/06/2017 | A Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with A 52-Week Blinded Extension (Pasadena) | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) | 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: aSyn Mab Product Code: RO7046015 INN or Proposed INN: N/A Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | France;United States;Spain;Austria;Germany | ||
| 5 | NCT03100149 (ClinicalTrials.gov) | June 27, 2017 | 29/3/2017 | A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants With Early Parkinson's Disease With a 6-Year All-Participants-on-Treatment Extension | Parkinson's Disease | Drug: RO7046015;Drug: Placebo | Hoffmann-La Roche | Prothena Biosciences Limited | Active, not recruiting | 40 Years | 80 Years | All | 316 | Phase 2 | United States;Austria;France;Germany;Spain |
| 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 |
| 6 | NCT02157714 (ClinicalTrials.gov) | June 2014 | 4/6/2014 | Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's Disease | Parkinson's Disease | Drug: PRX002;Other: Placebo | Prothena Biosciences Limited | Hoffmann-La Roche | Completed | 40 Years | 80 Years | Both | 64 | Phase 1 | United States |
| 7 | NCT02095171 (ClinicalTrials.gov) | March 2014 | 14/3/2014 | Single Ascending Dose Study of PRX002 in Healthy Subjects | A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy Subjects | Parkinson's Disease | Drug: PRX002;Other: Placebo | Prothena Biosciences Limited | Hoffmann-La Roche | Completed | 21 Years | 65 Years | Both | 40 | Phase 1 | United States |