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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522683-32-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Prothena Biosciences Limited | INDUSTRY |
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The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasinezumab | Experimental | Participants will receive Prasinezumab as an IV infusion in the double blind treatment period. Upon completion, eligible participants will enter into the Open Label Extension (OLE) phase. |
|
| Placebo | Experimental | Participants will receive placebo as an IV Infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasinezumab | Drug | Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score | Up to at least Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Motor Function as Measured by the MDS-UPDRS Part III off Medication Score | Baseline, Week 104 | |
| Time to Worsening of Participants Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42208564 | Derived | Nikolcheva T, Pagano G, Anzures-Cabrera J, Trundell D, Kustermann T, Simuni T, Marek K, Pavese N, Seppi K, Stocchi F, Postuma RB, Pross N, Monnet A, Respondek G, Schlegel V, Boak L, Rutten-Jacobs L, Kerchner GA, Brundin P, Svoboda H, Bonni A; PADOVA Investigators; Prasinezumab Study Group. Efficacy and safety of intravenous prasinezumab in individuals with early-stage Parkinson's disease on stable symptomatic monotherapy (PADOVA): a phase 2b, multicentre, randomised, double-blind, placebo-controlled study. Lancet. 2026 May 30;407(10544):2227-2240. doi: 10.1016/S0140-6736(26)00865-2. |
| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Placebo | Drug | Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol |
|
| Up to at least Week 104 |
| Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C), Overall Disease Subscale | Up to at least Week 104 |
| Time to increase in Levodopa Equivalent Daily Dose (LEDD) | Up to at least Week 104 |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | From Baseline up to 70 days after the final study dose (up to at least Week 104) |
| Percentage of Participants With Adverse Events of Special Interest (AESI) | From Baseline up to 70 days after the final study dose (up to at least Week 104) |
| Percentage of Participants With Infusion Related Reactions (IRRs) | From Baseline up to 70 days after the final study dose (up to at least Week 104) |
| Percentage of Participants With Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) | From Baseline up to 70 days after the final study dose (up to at least Week 104) |
| Serum Concentration of Prasinezumab | Predose and postdose at Baseline, Week 1, 4, 12, 24, 36, 52, 76, and after week 76 every 12 weeks thereafter until end of study (up to at least Week 104) |
| Percentage of Participants With Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline | At Baseline |
| Percentage of Participants With ADAs Against Prasinezumab During the Study | From Baseline up to 70 days after the final study dose (up to at least Week 104) |
| Barrow Neurological Institute |
| Recruiting |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Neurology Center of North Orange County | Recruiting | Fullerton | California | 92835 | United States |
| UC San Diego | Recruiting | La Jolla | California | 92037 | United States |
| Keck School of Medicine of USC | Recruiting | Los Angeles | California | 900033 | United States |
| UCLA Neurology Outpatient Clinic | Recruiting | Los Angeles | California | 90095 | United States |
| Parkinson?s Research Centers of America ? Palo Alto | Recruiting | Palo Alto | California | 94301 | United States |
| Profound Research LLC at The Neurology Center of Southern California | Recruiting | Pasadena | California | 91105 | United States |
| UCSF Weill Institute for Neurosciences | Recruiting | San Francisco | California | 94158 | United States |
| Rocky Mountain Movement Disorders | Recruiting | Englewood | Colorado | 80113 | United States |
| Institute for Neurodegenerative Disorders | Recruiting | New Haven | Connecticut | 06510 | United States |
| Georgetown University | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
| JEM Research LLC | Recruiting | Atlantis | Florida | 33462 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Recruiting | Boca Raton | Florida | 33486 | United States |
| K2 - Villages | Recruiting | Lady Lake | Florida | 32159 | United States |
| K2 Medical Research-Maitland | Recruiting | Maitland | Florida | 32751 | United States |
| Baptist Hospital of Miami | Recruiting | Miami | Florida | 33176 | United States |
| Charter Research - Winter Park/Orlando | Recruiting | Orlando | Florida | 32803 | United States |
| Hawaii Pacific Neuroscience | Recruiting | Honolulu | Hawaii | 96817 | United States |
| Northwestern University Feinberg School Of Medicine | Recruiting | Chicago | Illinois | 60611 | United States |
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Quest Research Institute | Recruiting | Farmington Hills | Michigan | 48334 | United States |
| Washington Uni School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| Cleveland Clinic Lou Ruvo | Recruiting | Las Vegas | Nevada | 89106 | United States |
| Renown Health | Recruiting | Reno | Nevada | 89502 | United States |
| Hackensack University Medical Center;Department of Neurology, Neuroscience Institute | Recruiting | Paramus | New Jersey | 07652 | United States |
| University of New Mexico | Recruiting | Albuquerque | New Mexico | 87106 | United States |
| Dent Neurological Institute | Recruiting | Amherst | New York | 14226 | United States |
| Parkinson's Research Centers of America - Long Island | Recruiting | Commack | New York | 11725 | United States |
| Weill Cornell Medical College | Recruiting | New York | New York | 10021 | United States |
| Asheville Neurology | Recruiting | Asheville | North Carolina | 28806 | United States |
| NeuroCare Center | Recruiting | Canton | Ohio | 44718 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| The Movement Disorder Clinic of Oklahoma | Recruiting | Tulsa | Oklahoma | 74136 | United States |
| University Pennsylvania Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny General Hospital | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
| Avera Medical Group | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
| Veracity Neuroscience | Recruiting | Memphis | Tennessee | 38157 | United States |
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37212 | United States |
| Texas Neurology PA | Recruiting | Dallas | Texas | 75206 | United States |
| Central Texas Neurology Consultants | Recruiting | Round Rock | Texas | 78681 | United States |
| University of Vermont Medical Center | Recruiting | Burlington | Vermont | 05401 | United States |
| University of Virginia Health System | Recruiting | Charlottesville | Virginia | 22903 | United States |
| VCU Health North Hospital | Recruiting | Richmond | Virginia | 23298 | United States |
| West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
| Southern Neurology | Recruiting | Kogarah | New South Wales | 2217 | Australia |
| Westmead Hospital | Recruiting | Westmead | New South Wales | 2145 | Australia |
| Monash Health | Recruiting | Clayton | Victoria | 3168 | Australia |
| Royal Melbourne Hospital | Recruiting | Parkville | Victoria | 3050 | Australia |
| The Alfred Hospital | Recruiting | Prahan | Victoria | 3181 | Australia |
| Perron Institute for Neurological and Translational Science | Recruiting | Nedlands | Western Australia | 6009 | Australia |
| Medizinische Universität Graz | Recruiting | Graz | 8036 | Austria |
| Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck | Recruiting | Innsbruck | 6020 | Austria |
| Kepler Universitätsklinikum GmbH - Neuromed Campus | Recruiting | Linz | 4020 | Austria |
| Medizinische Universität Wien | Recruiting | Vienna | 1090 | Austria |
| Klinik Ottakring | Recruiting | Vienna | 1160 | Austria |
| L2 Ip Instituto de Pesquisas Clinicas Ltda ME | Recruiting | Brasília | Federal District | 70200-730 | Brazil |
| Hospital das Clinicas - UFMG | Recruiting | Belo Horizonte | Minas Gerais | 31270-901 | Brazil |
| Instituto de Neurologia de Curitiba | Recruiting | Curitiba | Paraná | 81210-310 | Brazil |
| Núcleo de Pesquisa do Rio Grande do Sul | Recruiting | Porto Alegre | Rio Grande do Sul | 90430-001 | Brazil |
| Faculdade de Medicina de Ribeirão Preto - Universidade de Sao Paulo | Recruiting | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
| Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X* | Recruiting | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Centro de Pesquisas Clinicas | Recruiting | São Paulo | São Paulo | 01228-200 | Brazil |
| University Health Network | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
| CHUM | Recruiting | Montreal | Quebec | H2X 0A9 | Canada |
| Montreal Neurological Institute and Hospital | Recruiting | Montreal | Quebec | H3A 2B4 | Canada |
| Beijing Friendship Hospital Affiliated of Capital University of Medical Science | Recruiting | Beijing | 100050 | China |
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | 100053 | China |
| Beijing Tian Tan Hospital,Capital Medical University | Recruiting | Beijing | 100071 | China |
| Beijing Hospital of Ministry of Health | Recruiting | Beijing | 100730 | China |
| The First Hospital of Jilin University | Recruiting | Changchun | 130021 | China |
| West China Hospital of Sichuan University | Recruiting | Chengdu | 610041 | China |
| The First Affiliated Hospital, Chongqing Medical University | Recruiting | Chongqing | 400016 | China |
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | 350001 | China |
| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | 510080 | China |
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | 510115 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | 510120 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | 310009 | China |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | China |
| Nanjing Brain Hospital | Recruiting | Nanjing | 210029 | China |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | 200025 | China |
| Huashan Hospital, Fudan University | Recruiting | Shanghai | 200040 | China |
| The Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | 215004 | China |
| Tianjin Medical University General Hospital | Recruiting | Tianjin | 300052 | China |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Recruiting | Xi'an | 710061 | China |
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | China |
| Aarhus Universitetshospital Skejby | Recruiting | Aarhus N | 8200 | Denmark |
| Bispebjerg Hospital;Neurologisk Afdeling | Recruiting | København NV | 2400 | Denmark |
| Hospices Civils de Lyon - Hôpital Pierre Wertheimer | Recruiting | Bron | Rhône | 69003 | France |
| CHU de Clermont-Ferrand - Site Gabriel-Montpied | Recruiting | Clermont-Ferrand | 63000 | France |
| APHP - Hopital Henri Mondor | Recruiting | Créteil | 94010 | France |
| CHU de Grenoble - Hôpital André Michallon | Recruiting | La Tronche | 38700 | France |
| CHU de Limoges - Hôpital Dupuytren | Recruiting | Limoges | 87042 | France |
| CHU de Montpellier - Hôpital Gui de Chauliac | Recruiting | Montpellier | 34295 | France |
| CHU de Nice Hopital Pasteur | Recruiting | Nice | 06002 | France |
| APHP - Hopital de la Pitie Salpetriere | Recruiting | Paris | 75013 | France |
| Kliniken Beelitz GmbH | Recruiting | Beelitz | 14547 | Germany |
| Charite Universitätsmed. Berlin | Recruiting | Berlin | 10117 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin | Recruiting | Berlin | 12203 | Germany |
| St. Josef-Hospital, Klinik für Neurologie | Recruiting | Bochum | 44791 | Germany |
| Universitätsklinikum "Carl Gustav Carus" | Recruiting | Dresden | 01307 | Germany |
| Heinrich-Heine Universitätsklinik Düsseldorf | Recruiting | Düsseldorf | 40225 | Germany |
| Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie | Recruiting | Erlangen | 91054 | Germany |
| Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie | Recruiting | Freiburg im Breisgau | 79106 | Germany |
| Medizinische Hochschule Hannover, Klinik für Neurologie | Recruiting | Hanover | 30625 | Germany |
| Universitätsklinikum Heidelberg, Neurologische Klinik, Abteilung für Neuroradiologie | Recruiting | Heidelberg | 69120 | Germany |
| Universität Des Saarlandes | Recruiting | Homburg | 66421 | Germany |
| Paracelsus Elena Klinik Kassel | Recruiting | Kassel | 34128 | Germany |
| Klinikum rechts der Isar der TU München | Recruiting | Munich | 81675 | Germany |
| Universitatsklinikum Munster | Recruiting | Münster | 48149 | Germany |
| Universitaettsklinikum Tübingen | Recruiting | Tübingen | 72076 | Germany |
| Universitätsklinikum Würzburg, Neurologische Klinik und Poliklinik | Recruiting | Würzburg | 97080 | Germany |
| Università degli studi della Campania Luigi Vanvitelli | Recruiting | Naples | Campania | 80138 | Italy |
| Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona | Recruiting | Salerno | Campania | 84131 | Italy |
| Ospedale Bellaria | Recruiting | Bologna | Emilia-Romagna | 40139 | Italy |
| San Raffaele Cassino | Recruiting | Cassino | Lazio | 03043 | Italy |
| IRCCS San Raffaele;Clinical Trial Center | Recruiting | Rome | Lazio | 00166 | Italy |
| Policlinico Universitario Agostino Gemelli | Recruiting | Rome | Lazio | 00168 | Italy |
| Irccs A.O.U.San Martino Ist | Recruiting | Genoa | Liguria | 16132 | Italy |
| Azienda Ospedaliera Spedali Civili | Recruiting | Brescia | Lombardy | 25100 | Italy |
| Centro Parkinson e Parkinsonismi | Recruiting | Milan | Lombardy | 20126 | Italy |
| IRCCS Ospedale San Raffaele | Recruiting | Milan | Lombardy | 20132 | Italy |
| IRCCS Istituto Neurologico Carlo Besta | Recruiting | Milan | Lombardy | 20133 | Italy |
| A.O. Universitaria Pisana | Recruiting | Pisa | Tuscany | 56126 | Italy |
| Instituto Nacional de Neurologia y Neurocirugia | Recruiting | Mexico City | Mexico CITY (federal District) | 14390 | Mexico |
| Hospital General de Mexico | Recruiting | Mexico City | Mexico CITY (federal District) | 6726 | Mexico |
| Podlaskie Centrum Psychogeriatrii | Withdrawn | Bia?ystok | 15-756 | Poland |
| NZOZ Vitamed | Recruiting | Bydgoszcz | 85-079 | Poland |
| Szpital Sw. Wojciecha | Recruiting | Gda?sk | 80-462 | Poland |
| NEURO-CARE Sp. z o.o. Sp. Komandytowa | Recruiting | Katowice | 40-749 | Poland |
| Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K | Recruiting | Krakow | 31-505 | Poland |
| Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. | Recruiting | Lublin | 20-410 | Poland |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k. | Recruiting | Oświęcim | 32-600 | Poland |
| Nmedis sp. z o.o. | Recruiting | Rzeszów | 35-232 | Poland |
| NeuroProtect | Recruiting | Warsaw | 01-684 | Poland |
| Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o. | Recruiting | Warsaw | 03-242 | Poland |
| Hospital de Braga | Recruiting | Braga | 4710-243 | Portugal |
| Hospital da Luz Coimbra | Recruiting | Coimbra | 3020-479 | Portugal |
| Hospital Dr. Nélio Mendonça;Serviço de Neurologia | Recruiting | Funchal | 9004-514 | Portugal |
| Hospital da Senhora da Oliveira-Guimarães | Recruiting | Guimarães | Portugal |
| Hospital de Santa Maria | Recruiting | Lisbon | 1649-035 | Portugal |
| Hospital Pedro Hispano | Recruiting | Matosinhos Municipality | 4464-513 | Portugal |
| CNS - Campus Neurológico | Recruiting | Torres Vedras | 2560-280 | Portugal |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Boramae Medical Center | Recruiting | Seoul | 07061 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 110-744 | South Korea |
| Hospital General Universitario de Elche | Recruiting | Elche | Alicante | 03203 | Spain |
| Hospital General De Catalunya | Recruiting | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
| Policlinica Guipuzcoa | Recruiting | Donostia / San Sebastian | Guipuzcoa | 20009 | Spain |
| Complejo Hospitalario Universitario A Coruña | Recruiting | A Coruña | LA Coruna | 15006 | Spain |
| Hospital Universitario Fundación Alcorcón | Recruiting | Alcorcón | Madrid | 28922 | Spain |
| Hospital Quiron de Madrid | Recruiting | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Universitari Vall d Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Clinic Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hospital Ruber Juan Bravo | Recruiting | Madrid | 28006 | Spain |
| Hospital Universitario de La Princesa | Recruiting | Madrid | 28006 | Spain |
| Hospital Univ 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Regional Universitario de Malaga ? Hospital General | Recruiting | Málaga | 29009 | Spain |
| Hospital Universitario Virgen del Rocio | Recruiting | Seville | 41013 | Spain |
| Changhua Christian Hospital | Recruiting | Changhua County | 500 | Taiwan |
| China Medical University Hospital | Recruiting | North Dist. | 40447 | Taiwan |
| National Cheng Kung University Hospital | Recruiting | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
| Ninewells Hospital, Dundee- Scotland | Recruiting | Dundee | DD2 1SY | United Kingdom |
| Royal Devon and Exeter Hospital (Wonford) | Recruiting | Exeter | EX2 5DW | United Kingdom |
| Royal London Hospital | Recruiting | London | E1 1FR | United Kingdom |
| Charing Cross Hospital | Recruiting | London | W6 8RF | United Kingdom |
| Campus for Ageing and Vitality | Recruiting | Newcastle | NE4 5PL | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Recruiting | Oxford | OX3 7LE | United Kingdom |
| Plymouth Hospitals NHS Trust - Derriford Hospital | Recruiting | Plymouth,Devon | PL6 8DH | United Kingdom |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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