A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease (PADOVA)

A 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

This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinsons Disease
• Intervention / Treatment: Drug: Prasinezumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 586
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: BN42358 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medizinische Universität Graz; Universitätsklinik für Neurologie
  • Innsbruck, Austria, 6020
    • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
  • Wien, Austria, 1160
    • Klinik Ottakring; Neurologische Abteilung
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
    • Toronto, Ontario, Canada, M3B 2S7
      • Toronto Memory Program
  • Quebec
    • Gatineau, Quebec, Canada, J8Y 1W2
      • Clinique Neuro Outaouais
    • Montreal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institute and Hospital
• France
  • Bordeaux, France, 33000
    • Groupe Hospitalier Pellegrin
  • Bron cedex, France, 69677
    • Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)
  • Clermont-ferrand, France, 63003
    • Hôpital Gabriel Montpied
  • Creteil, France, 94000
    • Hôpital Henri Mondor; Centre Expert Parkinson
  • Grenoble, France, 38043
    • Hôpital Michallon - Centre d'Investigation Clinique; Unité de Pharmacologie Clinique - Inserm
  • Limoges, France, 87042
    • CHU de Limoges - Hopital Dupuytren
  • Marseille, France, 13385
    • Hôpital de la Timone
  • Montpellier, France, 34000
    • CHU Gui De Chauliac
  • Nice, France, 06002
    • CHU de Nice Hopital Pasteur
  • Paris, France, 75013
    • Hopital Pitie-Salpetriere APHP
  • Poitiers, France, 86000
    • CHU Poitiers
  • Rouen cedex, France, 76031
    • CHU Rouen Charles Nicolle; Centre Expert Parkinson Hôpitaux de Rouen
  • St Herblain, France, 44800
    • CHU de Nantes - Hôpital Laennec
  • Strasbourg, France, 67098
    • CHU Strasbourg Hôpital Hautepierre
  • Toulouse, France, 31059
    • CIC - Hôpital Purpan
• Italy
  • Campania
    • Napoli, Campania, Italy, 80138
      • Università degli studi della Campania Luigi Vanvitelli; Dip.Ass Int Med Int-I Clinica Neurologica
    • Salerno, Campania, Italy, 84131
      • Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona; Center for Neurodegenerative Disease
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40139
      • Ospedale Bellaria; Istituto delle Scienze Neurologiche
  • Lazio
    • Roma, Lazio, Italy, 00163
      • IRCCS San Raffaele Pisana; Clinical Trial Center
    • Roma, Lazio, Italy, 00168
      • Policlinico Universitario Agostino Gemelli; UOC Neurologia
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Irccs A.O.U.San Martino Ist; Dinogmi
  • Lombardia
    • Brescia, Lombardia, Italy, 25100
      • Azienda Ospedaliera Spedali Civili; Scienze Neurologiche
    • Milano, Lombardia, Italy, 20132
      • IRCCS Ospedale San Raffaele; U.O. di Neurologia
    • Milano, Lombardia, Italy, 20133
      • IRCCS Istituto Neurologico Carlo Besta; UOC Neurologia 1
  • Molise
    • Pozzilli (IS), Molise, Italy, 86077
      • IRCCS Neuromed; Neurologia I
  • Sicilia
    • Catania, Sicilia, Italy, 95123
      • A.O.U. Policlinico "G.Rodolico - San Marco"; Clinica Neurologica
  • Toscana
    • Pisa, Toscana, Italy, 56126
      • A.O. Universitaria Pisana; Neurologia
  • Umbria
    • Perugia, Umbria, Italy, 06156
      • AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica
    • Terni, Umbria, Italy, 05100
      • Azienda Ospedaliera S. Maria; SC Neurologia
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Azienda Ospedaliera di Padova; Dipartimento di Neuroscienze
• Luxembourg
  • Luxembourg, Luxembourg, 1210
    • Centre Hospitalier de Luxembourg
• Poland
  • ?ód?, Poland, 90-640
    • NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
  • Bydgoszcz, Poland, 85-079
    • NZOZ Vitamed
  • Gda?sk, Poland, 80-462
    • Szpital Sw. Wojciecha; Oddzial Neurologiczny
  • Krakow, Poland, 31-505
    • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
  • Lublin, Poland, 20-410
    • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
  • Rzeszów, Poland, 35-232
    • Nzoz Palomed
  • Warszawa, Poland, 01-684
    • Centrum Medyczne NeuroProtect
  • Warszawa, Poland, 00-416
    • Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego; Klinika Neurologii i Epileptologii
  • Warszawa, Poland, 03-242
    • Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.; Klinika Neurologii
• Spain
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
  • Barcelona, Spain, 08036
    • Hospital Clinic Servicio de Neurologia
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron; Servicio de Neurología
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos. Servicio de Neurología
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre; Servicio de Neurologia
  • Madrid, Spain, 28006
    • Hospital Ruber Juan Bravo
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa; Servicio de Neurologia
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos; Servicio de Neurología
  • Malaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena; Servicio de Neurologia
  • Sevilla, Spain, 41013
    • Hospital Virgen del Rocío; Servicio de Neurología
  • Valencia, Spain, 46017
    • Hospital Universitario Dr. Peset; Servicio de Neurologia
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe; Servicio de Neurología
  • Zaragoza, Spain, 50012
    • Servicio de Neurología Hospital Viamed Montecanal.
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche; Servicio de Neurología
  • Barcelona
    • Sant Cugat del Valles, Barcelona, Spain, 8195
      • Hospital General De Catalunya; Servicio de Neurologia
  • Guipuzcoa
    • Donosti-San Sebastián, Guipuzcoa, Spain, 20014
      • Policlínica Guipuzkoa; Servicio de Neurología
  • LA Coruña
    • Coruña, LA Coruña, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Hospital Universitario Fundación Alcorcón; Servicio de Neurología
    • Móstoles, Madrid, Spain, 28938
      • HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Quiron de Madrid; Servicio de Neurologia
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra
  • Palencia
    • Plasencia, Palencia, Spain, 10600
      • Hospital Virgen del Puerto
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • Hospital de Cruces; Servicio de Neurologia
• United Kingdom
  • Dundee, United Kingdom, DD2 1SY
    • Ninewells Hospital, Dundee- Scotland; Neurology
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, SW9 8RR
    • Kings College Hospital
  • Newcastle, United Kingdom, NE4 5PL
    • Campus for Ageing and Vitality
  • Oxford, United Kingdom, OX3 7LE
    • Oxford University Hospitals NHS Foundation Trust
  • Peterborough, United Kingdom, PE3 9GZ
    • North West Anglia NHS Foundation Trust
  • Plymouth, United Kingdom, PL6 8BT
    • Derriford Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
  • California
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • La Jolla, California, United States, 92037
      • UC San Diego; ACTRI
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Los Angeles, California, United States, 900033
      • Keck School of Medicine of USC
    • San Francisco, California, United States, 94117
      • University of California San Francisco
  • Colorado
    • Englewood, Colorado, United States, 80113
      • CenExel Rocky Mountain Clinical Research, LLC
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Institute for Neurodegenerative Disorders
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research LLC
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Tampa, Florida, United States, 33612
      • University of South Florida
    • Winter Park, Florida, United States, 32792
      • Charter Research - Winter Park/Orlando
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University, School of Medicine
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114-2759
      • Massachusetts General Hospital
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford Hospital; Henry Ford Medical Center
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurological Institute
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • The Movement Disorder Clinic of Oklahoma
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University Pennsylvania Hospital
  • Texas
    • Dallas, Texas, United States, 75206
      • Texas Neurology PA
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine Medical Center
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consultants
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Neurology Specialists
  • Washington
    • Kirkland, Washington, United States, 98034
      • Evergreen Health Care Center
    • Spokane, Washington, United States, 99202
      • Inland Northwest Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism
• On symptomatic PD medication, with stable doses for at least 3 months prior to baseline
• A diagnosis of PD for at least 3 months to maximum 3 years at screening
• MDS-UPDRS Part IV score of 0 at screening and prior to randomization
• Hoehn and Yahr (H&Y) Stage I or II in OFF medication state at screening and prior to randomization
• Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader
• No anticipated changes in PD medication from baseline throughout the study duration based on clinical status during screening
• Willingness and ability to use a smartphone application to measure PD-related symptoms for the duration of the study
• Willingness and ability to wear a smartwatch to measure PD-related motor signs

Exclusion Criteria:

• Medical history indicating a Parkinsonian syndrome other than idiopathic PD
• Diagnosis of PD dementia
• Diagnosis of a significant neurologic disease other than PD
• Within the last year, unstable or clinically significant cardiovascular disease
• Uncontrolled hypertension
• Drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (Nicotine is allowed, Marijuana use is not allowed)
• Clinically significant abnormalities in laboratory test results at the screening visit, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis
• Allergy to any of the components of prasinezumab, a known hypersensitivity, or a previous IRR following administration of any other monoclonal antibody
• Any contraindications to obtaining a brain magnetic resonance imaging (MRI)
• Any contraindications to DaT-SPECT imaging

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prasinezumab; Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W). Participants will enter into the optional Open Label Extension (OLE) once the double-blind treatment period has completed.	Drug: Prasinezumab; Prasinezumab will be administered as an IV infusion to participants Q4W.
Placebo Comparator: Placebo; Participants will receive placebo as an IV infusion Q4W.	Drug: Placebo; Prasinezumab placebo will be administered to participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Confirmed Motor Progression Event	From baseline until 28 days after final dose of study treatment
OLE: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)	From baseline until 70 days after final dose of study treatment
OLE: Number of Participants with Adverse Events of Special Interest (AESI)	From baseline until 70 days after final dose of study treatment
OLE: Number of Participants with Infusion Related Reactions (IRRs)	From baseline until 70 days after final dose of study treatment
OLE: Change from Baseline in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)	From baseline until 70 days after final dose of study treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to Meaningful Worsening in Patient Global Impression of Change (PGI-C, Overall Disease Subscale)	From baseline until 28 days after final dose of study treatment
Time to Meanaingful Worsening in Clinician Global Impression of Change (CGI-C, Overall Disease Subscale)	From baseline until 28 days after final dose of study treatment
Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV	From baseline until 28 days after final dose of study treatment
Percentage of Participants With AEs and SAEs	From baseline until 70 days after final dose of study treatment
Number of Participants with AESI	From baseline until 70 days after final dose of study treatment
Number of Participants with IRRs	From baseline until 70 days after final dose of study treatment
Change from Baseline in Suicidal Ideation, as Measured by the C-SSRS	From baseline until 28 days after final dose of study treatment
Serum Concentration of Prasinezumab	From weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 and after week 76 every 12 weeks therafter until end of study (approximately 28 days after the final dose)
Percentage of Participants with Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline	At Baseline
Percentage of Participants with ADAs Against Prasinezumab During the Study	Up to end of study visit (approximately 76 weeks)
Time-to-worsening of Participants Motor Function as Reported by the Participant in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and in the Presence of a Confirmed Motor Progression Event	From baseline until 28 days after final dose of study treatment
Change in Motor Function from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Score	From baseline to Week 76
Change in Bradykinesia and Rigidity from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia and Rigidity Subscore	From baseline to Week 76

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Prothena Biosciences Limited
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Estimated): September 20, 2024
• Study Completion (Estimated): November 27, 2026

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: BN42358; 2020-004997-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No