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

Parkinsons Disease Clinical Trial

— PADOVA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04777331
• Other study ID #: BN42358
• Secondary ID: 2020-004997-23
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 5, 2021
• Est. completion date: November 27, 2026

Study information

• Verified date: December 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 586
• Est. completion date: November 27, 2026
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinsons Disease

Intervention

Drug:
• Prasinezumab
Prasinezumab will be administered as an IV infusion to participants Q4W.
• Placebo
Prasinezumab placebo will be administered to participants.

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz; Universitätsklinik für Neurologie	Graz
Austria	Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie	Innsbruck
Austria	Klinik Ottakring; Neurologische Abteilung	Wien
Canada	Clinique Neuro Outaouais	Gatineau	Quebec
Canada	Montreal Neurological Institute and Hospital	Montreal	Quebec
Canada	Toronto Memory Program	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
France	Groupe Hospitalier Pellegrin	Bordeaux
France	Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)	Bron cedex
France	Hopital Gabriel Montpied	Clermont-ferrand
France	Hôpital Henri Mondor; Centre Expert Parkinson	Creteil
France	Hôpital Michallon - Centre d'Investigation Clinique; Unité de Pharmacologie Clinique - Inserm	Grenoble
France	CHU de Limoges - Hôpital Dupuytren	Limoges
France	hopital de la Timone	Marseille
France	CHU Gui de Chauliac	Montpellier
France	CHU de Nice Hopital Pasteur	Nice
France	Hopital Pitie-Salpetriere APHP	Paris
France	CHU Poitiers	Poitiers
France	CHU Rouen Charles Nicolle; Centre Expert Parkinson Hôpitaux de Rouen	Rouen cedex
France	CHU de Nantes - Hopital Laennec	St Herblain
France	CHU Strasbourg Hôpital Hautepierre	Strasbourg
France	CIC - Hôpital Purpan	Toulouse
Italy	Ospedale Bellaria; Istituto delle Scienze Neurologiche	Bologna	Emilia-Romagna
Italy	Azienda Ospedaliera Spedali Civili; Scienze Neurologiche	Brescia	Lombardia
Italy	A.O.U. Policlinico "G.Rodolico - San Marco"; Clinica Neurologica	Catania	Sicilia
Italy	Irccs A.O.U.San Martino Ist; Dinogmi	Genova	Liguria
Italy	IRCCS Istituto Neurologico Carlo Besta; UOC Neurologia 1	Milano	Lombardia
Italy	IRCCS Ospedale San Raffaele; U.O. di Neurologia	Milano	Lombardia
Italy	Università degli studi della Campania Luigi Vanvitelli; Dip.Ass Int Med Int-I Clinica Neurologica	Napoli	Campania
Italy	Azienda Ospedaliera di Padova; Dipartimento di Neuroscienze	Padova	Veneto
Italy	AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica	Perugia	Umbria
Italy	A.O. Universitaria Pisana; Neurologia	Pisa	Toscana
Italy	IRCCS Neuromed; Neurologia I	Pozzilli (IS)	Molise
Italy	IRCCS San Raffaele Pisana; Clinical Trial Center	Roma	Lazio
Italy	Policlinico Universitario Agostino Gemelli; UOC Neurologia	Roma	Lazio
Italy	Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona; Center for Neurodegenerative Disease	Salerno	Campania
Italy	Azienda Ospedaliera S. Maria; SC Neurologia	Terni	Umbria
Luxembourg	Centre Hospitalier de Luxembourg	Luxembourg
Poland	NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki	?ód?
Poland	NZOZ Vitamed	Bydgoszcz
Poland	Szpital Sw. Wojciecha; Oddzial Neurologiczny	Gda?sk
Poland	Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K	Krakow
Poland	Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.	Lublin
Poland	Nzoz Palomed	Rzeszów
Poland	Centrum Medyczne NeuroProtect	Warszawa
Poland	Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.; Klinika Neurologii	Warszawa
Poland	Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego; Klinika Neurologii i Epileptologii	Warszawa
Spain	Hospital Universitario Fundación Alcorcón; Servicio de Neurología	Alcorcon	Madrid
Spain	Hospital de Cruces; Servicio de Neurologia	Barakaldo	Vizcaya
Spain	Hospital Clinic Servicio de Neurologia	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia	Barcelona
Spain	Hospital Vall d'Hebron; Servicio de Neurología	Barcelona
Spain	Hospital Universitario de Burgos. Servicio de Neurología	Burgos
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia	Coruña	LA Coruña
Spain	Policlínica Guipuzkoa; Servicio de Neurología	Donosti-San Sebastián	Guipuzcoa
Spain	Hospital General Universitario de Elche; Servicio de Neurología	Elche	Alicante
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Neurologia	Madrid
Spain	Hospital Ruber Juan Bravo	Madrid
Spain	Hospital Universitario 12 de Octubre; Servicio de Neurologia	Madrid
Spain	Hospital Universitario Clínico San Carlos; Servicio de Neurología	Madrid
Spain	Hospital Universitario de la Princesa; Servicio de Neurologia	Madrid
Spain	Hospital Regional Universitario Carlos Haya; Servicio de Neurologia	Malaga
Spain	HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría	Móstoles	Madrid
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Virgen del Puerto	Plasencia	Palencia
Spain	Hospital Quiron de Madrid; Servicio de Neurologia	Pozuelo de Alarcon	Madrid
Spain	Hospital General De Catalunya; Servicio de Neurologia	Sant Cugat del Valles	Barcelona
Spain	Hospital Universitario Virgen Macarena; Servicio de Neurologia	Sevilla
Spain	Hospital Virgen del Rocío; Servicio de Neurología	Sevilla
Spain	Hospital Universitari i Politecnic La Fe; Servicio de Neurología	Valencia
Spain	Hospital Universitario Dr. Peset; Servicio de Neurologia	Valencia
Spain	Servicio de Neurología Hospital Viamed Montecanal.	Zaragoza
United Kingdom	Ninewells Hospital, Dundee- Scotland; Neurology	Dundee
United Kingdom	Charing Cross Hospital	London
United Kingdom	Kings College Hospital	London
United Kingdom	Campus for Ageing and Vitality	Newcastle
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	North West Anglia NHS Foundation Trust	Peterborough
United Kingdom	Derriford Hospital	Plymouth
United States	Dent Neurological Institute	Amherst	New York
United States	JEM Research LLC	Atlantis	Florida
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Northwestern University Feinberg School Of Medicine	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Texas Neurology PA	Dallas	Texas
United States	CenExel Rocky Mountain Clinical Research, LLC	Englewood	Colorado
United States	Quest Research Institute	Farmington Hills	Michigan
United States	Neurology Center of North Orange County	Fullerton	California
United States	Baylor College of Medicine Medical Center	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Evergreen Health Care Center	Kirkland	Washington
United States	UC San Diego; ACTRI	La Jolla	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Keck School of Medicine of USC	Los Angeles	California
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut
United States	Sentara Neurology Specialists	Norfolk	Virginia
United States	Renstar Medical Research	Ocala	Florida
United States	University Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Central Texas Neurology Consultants	Round Rock	Texas
United States	University of California San Francisco	San Francisco	California
United States	Inland Northwest Research	Spokane	Washington
United States	Southern Illinois University, School of Medicine	Springfield	Illinois
United States	University of South Florida	Tampa	Florida
United States	The Movement Disorder Clinic of Oklahoma	Tulsa	Oklahoma
United States	Henry Ford Hospital; Henry Ford Medical Center	West Bloomfield	Michigan
United States	Charter Research - Winter Park/Orlando	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Prothena Biosciences Limited

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Italy,  Luxembourg,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Confirmed Motor Progression Event		From baseline until 28 days after final dose of study treatment
Primary	OLE: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)		From baseline until 70 days after final dose of study treatment
Primary	OLE: Number of Participants with Adverse Events of Special Interest (AESI)		From baseline until 70 days after final dose of study treatment
Primary	OLE: Number of Participants with Infusion Related Reactions (IRRs)		From baseline until 70 days after final dose of study treatment
Primary	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	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
Secondary	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
Secondary	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
Secondary	Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV		From baseline until 28 days after final dose of study treatment
Secondary	Change in Motor Function from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Score		From baseline to Week 76
Secondary	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
Secondary	Percentage of Participants With AEs and SAEs		From baseline until 70 days after final dose of study treatment
Secondary	Number of Participants with AESI		From baseline until 70 days after final dose of study treatment
Secondary	Number of Participants with IRRs		From baseline until 70 days after final dose of study treatment
Secondary	Change from Baseline in Suicidal Ideation, as Measured by the C-SSRS		From baseline until 28 days after final dose of study treatment
Secondary	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)
Secondary	Percentage of Participants with Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline		At Baseline
Secondary	Percentage of Participants with ADAs Against Prasinezumab During the Study		Up to end of study visit (approximately 76 weeks)