ASyn Mab ( 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-004997-23-PL
(EUCTR)
09/06/202103/09/2021A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's DiseaseA PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE Early 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: Prasinezumab
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
575Phase 2France;United States;Canada;Spain;Poland;Austria;United Kingdom;Italy
2EUCTR2020-004997-23-AT
(EUCTR)
27/05/202116/03/2021A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's DiseaseA PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE Early 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: Prasinezumab
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
575Phase 2Austria;United Kingdom;Italy;France;United States;Canada;Spain;Poland
3EUCTR2020-004997-23-ES
(EUCTR)
25/05/202101/09/2021A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's DiseaseA PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE Early 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: Prasinezumab
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
575Phase 2France;United States;Canada;Poland;Spain;Austria;United Kingdom;Italy
4EUCTR2020-004997-23-FR
(EUCTR)
11/05/202102/03/2021A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's DiseaseA PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE Early 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: Prasinezumab
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
575Phase 2United States;France;Canada;Spain;Poland;Austria;United Kingdom;Italy
5EUCTR2020-004997-23-IT
(EUCTR)
19/04/202108/06/2021A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's DiseaseA PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE - NA Early 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: Prasinezumab
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
575Phase 2France;United States;Canada;Spain;Poland;Austria;United Kingdom;Italy
6EUCTR2017-000087-15-DE
(EUCTR)
21/12/201717/05/2017A 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, PLACEBOCONTROLLED, 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-PARTICIPANTSON-TREATMENT 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/PRASINEZUMAB
INN or Proposed INN: N/A
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;France;Spain;Austria;Germany
7EUCTR2017-000087-15-AT
(EUCTR)
17/08/201718/05/2017A 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, PLACEBOCONTROLLED, 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-PARTICIPANTSONTREATMENT 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2France;United States;Spain;Austria;Germany
8EUCTR2017-000087-15-FR
(EUCTR)
27/07/201730/10/2017A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;France;Spain;Austria;Germany
9EUCTR2017-000087-15-ES
(EUCTR)
26/07/201708/06/2017A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2France;United States;Spain;Austria;Germany