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

Primary Purpose

Parkinsons Disease

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Prasinezumab
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinsons Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Barrow Neurological Institute
  • Neurology Center of North Orange County
  • UC San Diego; ACTRI
  • Keck School of Medicine of USC
  • Cedars Sinai Medical Center
  • University of California San Francisco
  • CenExel Rocky Mountain Clinical Research, LLC
  • Institute for Neurodegenerative Disorders
  • JEM Research LLC
  • Parkinson's Disease and Movement Disorders Center of Boca Raton
  • ClinCloud, LLC
  • Renstar Medical Research
  • Synexus Clinical Research
  • University of South Florida
  • Conquest Research, LLC
  • Charter Research - Winter Park/Orlando
  • Northwestern University Feinberg School Of Medicine
  • Southern Illinois University, School of Medicine
  • Indiana University Health University Hospital
  • University of Kansas Medical Center
  • Massachusetts General Hospital
  • Quest Research Institute
  • Henry Ford Hospital; Henry Ford Medical Center
  • Meridian Clinical Research, Llc
  • Wr-Crcn, Llc
  • Dent Neurological Institute
  • Cleveland Clinic
  • The Movement Disorder Clinic of Oklahoma
  • University Pennsylvania Hospital
  • Abington Neurological Associates Willow Grove
  • Texas Neurology PA
  • Baylor College of Medicine Medical Center
  • Central Texas Neurology Consultants
  • University of Vermont Medical Center
  • Sentara Neurology Specialists
  • Evergreen Health Care Center
  • Inland Northwest Research
  • Medizinische Universität Graz; Universitätsklinik für Neurologie
  • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
  • Klinik Ottakring; Neurologische Abteilung
  • Toronto Memory Program
  • Toronto Western Hospital
  • Clinique Neuro Outaouais
  • Montreal Neurological Institute and Hospital
  • Groupe Hospitalier Pellegrin
  • Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)
  • Hopital Gabriel Montpied
  • Hôpital Henri Mondor; Centre Expert Parkinson
  • Hôpital Michallon - Centre d'Investigation Clinique; Unité de Pharmacologie Clinique - Inserm
  • CHU de Limoges - Hôpital Dupuytren
  • hopital de la Timone
  • CHU Gui de Chauliac
  • CHU de Nice Hopital Pasteur
  • Hopital Pitie-Salpetriere APHP
  • CHU Poitiers
  • CHU Rouen Charles Nicolle; Centre Expert Parkinson Hôpitaux de Rouen
  • CHU de Nantes - Hopital Laennec
  • CHU Strasbourg Hôpital Hautepierre
  • CIC - Hôpital Purpan
  • Università degli studi della Campania Luigi Vanvitelli; Dip.Ass Int Med Int-I Clinica Neurologica
  • Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona; Center for Neurodegenerative Disease
  • Ospedale Bellaria; Istituto delle Scienze Neurologiche
  • IRCCS San Raffaele Pisana; Clinical Trial Center
  • Policlinico Universitario Agostino Gemelli; UOC Neurologia
  • Irccs A.O.U.San Martino Ist; Dinogmi
  • Azienda Ospedaliera Spedali Civili; Scienze Neurologiche
  • IRCCS Ospedale San Raffaele; U.O. di Neurologia
  • IRCCS Istituto Neurologico Carlo Besta; UOC Neurologia 1
  • IRCCS Neuromed; Neurologia I
  • A.O.U. Policlinico "G.Rodolico - San Marco"; Clinica Neurologica
  • A.O. Universitaria Pisana; Neurologia
  • AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica
  • Azienda Ospedaliera S. Maria; SC Neurologia
  • Azienda Ospedaliera di Padova; Dipartimento di Neuroscienze
  • Centre Hospitalier de Luxembourg
  • NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
  • NZOZ Vitamed
  • Szpital Sw. Wojciecha; Oddzial Neurologiczny
  • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
  • Nzoz Palomed
  • Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego; Klinika Neurologii i Epileptologii
  • Centrum Medyczne NeuroProtect
  • Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.; Klinika Neurologii
  • Hospital General Universitario de Elche; Servicio de Neurología
  • Hospital General De Catalunya; Servicio de Neurologia
  • Policlínica Guipuzkoa; Servicio de Neurología
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
  • Hospital Universitario Fundación Alcorcón; Servicio de Neurología
  • HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría
  • Hospital Quiron de Madrid; Servicio de Neurologia
  • Clinica Universidad de Navarra
  • Hospital Virgen del Puerto
  • Hospital de Cruces; Servicio de Neurologia
  • Hospital Vall d'Hebron; Servicio de Neurología
  • Hospital Clinic Servicio de Neurologia
  • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
  • Hospital Universitario de Burgos. Servicio de Neurología
  • Hospital Ruber Juan Bravo
  • Hospital Universitario de la Princesa; Servicio de Neurologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
  • Hospital Universitario Clínico San Carlos; Servicio de Neurología
  • Hospital Universitario 12 de Octubre; Servicio de Neurologia
  • Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
  • Hospital Universitario Virgen Macarena; Servicio de Neurologia
  • Hospital Virgen del Rocío; Servicio de Neurología
  • Hospital Universitario Dr. Peset; Servicio de Neurologia
  • Hospital Universitari i Politecnic La Fe; Servicio de Neurología
  • Servicio de Neurología Hospital Viamed Montecanal.
  • Ninewells Hospital, Dundee- Scotland; Neurology
  • Kings College Hospital
  • Charing Cross Hospital
  • Campus for Ageing and Vitality
  • Oxford University Hospitals NHS Foundation Trust
  • North West Anglia NHS Foundation Trust
  • Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prasinezumab

Placebo

Arm Description

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.

Participants will receive placebo as an IV infusion Q4W.

Outcomes

Primary Outcome Measures

Time to Confirmed Motor Progression Event
OLE: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
OLE: Number of Participants with Adverse Events of Special Interest (AESI)
OLE: Number of Participants with Infusion Related Reactions (IRRs)
OLE: Change from Baseline in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

Secondary Outcome Measures

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 Confirmed by the Clinician in MDS-UPDRS Part III
Time to Meaningful Worsening in Patient Global Impression of Change (PGI-C, Overall Disease Subscale)
Time to Meanaingful Worsening in Clinician Global Impression of Change (CGI-C, Overall Disease Subscale)
Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV
Change in Motor Function from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Total Score
Change in Bradykinesia from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia Subscore
Change in Motor Aspects of Experiences of Daily Living from Baseline to Week 76, as Measured by MDS-UPDRS Part II
Percentage of Participants With AEs and SAEs
Number of Participants with AESI
Number of Participants with IRRs
Change from Baseline in Suicidal Ideation, as Measured by the C-SSRS
Serum Concentration of Prasinezumab
Percentage of Participants with Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline
Percentage of Participants with ADAs Against Prasinezumab During the Study

Full Information

First Posted
February 26, 2021
Last Updated
September 25, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Prothena Biosciences Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04777331
Brief Title
A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
September 20, 2024 (Anticipated)
Study Completion Date
November 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Prothena Biosciences Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsons Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
586 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prasinezumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo as an IV infusion Q4W.
Intervention Type
Drug
Intervention Name(s)
Prasinezumab
Intervention Description
Prasinezumab will be administered as an IV infusion to participants Q4W.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Prasinezumab placebo will be administered to participants.
Primary Outcome Measure Information:
Title
Time to Confirmed Motor Progression Event
Time Frame
From baseline until 28 days after final dose of study treatment
Title
OLE: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time Frame
From baseline until 70 days after final dose of study treatment
Title
OLE: Number of Participants with Adverse Events of Special Interest (AESI)
Time Frame
From baseline until 70 days after final dose of study treatment
Title
OLE: Number of Participants with Infusion Related Reactions (IRRs)
Time Frame
From baseline until 70 days after final dose of study treatment
Title
OLE: Change from Baseline in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame
From baseline until 70 days after final dose of study treatment
Secondary Outcome Measure Information:
Title
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 Confirmed by the Clinician in MDS-UPDRS Part III
Time Frame
From baseline until 28 days after final dose of study treatment
Title
Time to Meaningful Worsening in Patient Global Impression of Change (PGI-C, Overall Disease Subscale)
Time Frame
From baseline until 28 days after final dose of study treatment
Title
Time to Meanaingful Worsening in Clinician Global Impression of Change (CGI-C, Overall Disease Subscale)
Time Frame
From baseline until 28 days after final dose of study treatment
Title
Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV
Time Frame
From baseline until 28 days after final dose of study treatment
Title
Change in Motor Function from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Total Score
Time Frame
From baseline to Week 76
Title
Change in Bradykinesia from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia Subscore
Time Frame
From baseline to Week 76
Title
Change in Motor Aspects of Experiences of Daily Living from Baseline to Week 76, as Measured by MDS-UPDRS Part II
Time Frame
From baseline to Week 76
Title
Percentage of Participants With AEs and SAEs
Time Frame
From baseline until 70 days after final dose of study treatment
Title
Number of Participants with AESI
Time Frame
From baseline until 70 days after final dose of study treatment
Title
Number of Participants with IRRs
Time Frame
From baseline until 70 days after final dose of study treatment
Title
Change from Baseline in Suicidal Ideation, as Measured by the C-SSRS
Time Frame
From baseline until 28 days after final dose of study treatment
Title
Serum Concentration of Prasinezumab
Time Frame
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)
Title
Percentage of Participants with Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline
Time Frame
At Baseline
Title
Percentage of Participants with ADAs Against Prasinezumab During the Study
Time Frame
Up to end of study visit (approximately 76 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
UC San Diego; ACTRI
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Keck School of Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
900033
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
CenExel Rocky Mountain Clinical Research, LLC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
JEM Research LLC
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
ClinCloud, LLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Synexus Clinical Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Conquest Research, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Charter Research - Winter Park/Orlando
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Northwestern University Feinberg School Of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Southern Illinois University, School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Indiana University Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2759
Country
United States
Facility Name
Quest Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Henry Ford Hospital; Henry Ford Medical Center
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Meridian Clinical Research, Llc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Wr-Crcn, Llc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Dent Neurological Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Movement Disorder Clinic of Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
University Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Abington Neurological Associates Willow Grove
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Texas Neurology PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
Facility Name
Baylor College of Medicine Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Central Texas Neurology Consultants
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Sentara Neurology Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Evergreen Health Care Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Inland Northwest Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Medizinische Universität Graz; Universitätsklinik für Neurologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Klinik Ottakring; Neurologische Abteilung
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Toronto Memory Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Clinique Neuro Outaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 1W2
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Groupe Hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)
City
Bron cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Hopital Gabriel Montpied
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Henri Mondor; Centre Expert Parkinson
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Hôpital Michallon - Centre d'Investigation Clinique; Unité de Pharmacologie Clinique - Inserm
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHU de Limoges - Hôpital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
hopital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
CHU de Nice Hopital Pasteur
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Hopital Pitie-Salpetriere APHP
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
CHU Rouen Charles Nicolle; Centre Expert Parkinson Hôpitaux de Rouen
City
Rouen cedex
ZIP/Postal Code
76031
Country
France
Facility Name
CHU de Nantes - Hopital Laennec
City
St Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
CHU Strasbourg Hôpital Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
CIC - Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Università degli studi della Campania Luigi Vanvitelli; Dip.Ass Int Med Int-I Clinica Neurologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80138
Country
Italy
Facility Name
Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona; Center for Neurodegenerative Disease
City
Salerno
State/Province
Campania
ZIP/Postal Code
84131
Country
Italy
Facility Name
Ospedale Bellaria; Istituto delle Scienze Neurologiche
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40139
Country
Italy
Facility Name
IRCCS San Raffaele Pisana; Clinical Trial Center
City
Roma
State/Province
Lazio
ZIP/Postal Code
00163
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli; UOC Neurologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Irccs A.O.U.San Martino Ist; Dinogmi
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili; Scienze Neurologiche
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25100
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele; U.O. di Neurologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
IRCCS Istituto Neurologico Carlo Besta; UOC Neurologia 1
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
IRCCS Neuromed; Neurologia I
City
Pozzilli (IS)
State/Province
Molise
ZIP/Postal Code
86077
Country
Italy
Facility Name
A.O.U. Policlinico "G.Rodolico - San Marco"; Clinica Neurologica
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
A.O. Universitaria Pisana; Neurologia
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06156
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria; SC Neurologia
City
Terni
State/Province
Umbria
ZIP/Postal Code
05100
Country
Italy
Facility Name
Azienda Ospedaliera di Padova; Dipartimento di Neuroscienze
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Centre Hospitalier de Luxembourg
City
Luxembourg
ZIP/Postal Code
1210
Country
Luxembourg
Facility Name
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
City
?ód?
ZIP/Postal Code
90-640
Country
Poland
Facility Name
NZOZ Vitamed
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Szpital Sw. Wojciecha; Oddzial Neurologiczny
City
Gda?sk
ZIP/Postal Code
80-462
Country
Poland
Facility Name
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
City
Lublin
ZIP/Postal Code
20-410
Country
Poland
Facility Name
Nzoz Palomed
City
Rzeszów
ZIP/Postal Code
35-232
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego; Klinika Neurologii i Epileptologii
City
Warszawa
ZIP/Postal Code
00-416
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Facility Name
Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.; Klinika Neurologii
City
Warszawa
ZIP/Postal Code
03-242
Country
Poland
Facility Name
Hospital General Universitario de Elche; Servicio de Neurología
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital General De Catalunya; Servicio de Neurologia
City
Sant Cugat del Valles
State/Province
Barcelona
ZIP/Postal Code
8195
Country
Spain
Facility Name
Policlínica Guipuzkoa; Servicio de Neurología
City
Donosti-San Sebastián
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
City
Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Fundación Alcorcón; Servicio de Neurología
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28938
Country
Spain
Facility Name
Hospital Quiron de Madrid; Servicio de Neurologia
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Virgen del Puerto
City
Plasencia
State/Province
Palencia
ZIP/Postal Code
10600
Country
Spain
Facility Name
Hospital de Cruces; Servicio de Neurologia
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Vall d'Hebron; Servicio de Neurología
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario de Burgos. Servicio de Neurología
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital Ruber Juan Bravo
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario de la Princesa; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Neurologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Virgen del Rocío; Servicio de Neurología
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario Dr. Peset; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe; Servicio de Neurología
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Servicio de Neurología Hospital Viamed Montecanal.
City
Zaragoza
ZIP/Postal Code
50012
Country
Spain
Facility Name
Ninewells Hospital, Dundee- Scotland; Neurology
City
Dundee
ZIP/Postal Code
DD2 1SY
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SW9 8RR
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Campus for Ageing and Vitality
City
Newcastle
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
North West Anglia NHS Foundation Trust
City
Peterborough
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8BT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

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