Prasinezumab ( DrugBank: Prasinezumab )


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8

6. パーキンソン病


臨床試験数 : 2,298 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2020-004997-23-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 2France;United States;Canada;Spain;Poland;Austria;United Kingdom;Italy
2EUCTR2020-004997-23-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
3EUCTR2020-004997-23-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
4NCT04777331
(ClinicalTrials.gov)
May 5, 202126/2/2021A 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 DiseaseParkinsons DiseaseDrug: Prasinezumab;Drug: PlaceboHoffmann-La RocheProthena Biosciences LimitedRecruiting50 Years85 YearsAll575Phase 2United States;Austria;Canada;France;Italy;Poland;Spain;United Kingdom;Germany
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
8NCT03100149
(ClinicalTrials.gov)
June 27, 201729/3/2017A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's DiseaseA 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 ExtensionParkinson's DiseaseDrug: RO7046015;Drug: PlaceboHoffmann-La RocheProthena Biosciences LimitedActive, not recruiting40 Years80 YearsAll316Phase 2United States;Austria;France;Germany;Spain