AzTrials
AzTrials

Parkinson's DiseasePhase 3PARAISONCT07174310

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

A Phase 3 study testing Prasinezumab in people with Parkinson's Disease, run by Hoffmann-La Roche at 192 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Prasinezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
900 participants
Where
192 sitesin 17 countries
Study dates
24 Nov 2025to 30 Jun 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body weight within 40-110 kilograms (kg) (88-242 pounds [lbs]) and a body mass index within the range 18-34 kg/m2
  • Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
  • Has received monotherapy treatment
  • An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
  • Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization
  • Agreement to adhere to the contraception requirements

Who cannot join

  • Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
  • Medical history indicating a parkinsonian syndrome other than idiopathic PD
  • Diagnosis of a significant neurologic disease other than PD
  • Chronic uncontrolled hypertension

Trial locations and contacts

192 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

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

192 sites in 17 countries

United States53 sites, 53 recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87106

    Recruiting

  • Dent Neurological Institute

    Amherst, New York, 14226

    Recruiting

  • Asheville Neurology

    Asheville, North Carolina, 28806

    Recruiting

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

    Recruiting

  • JEM Research LLC

    Atlantis, Florida, 33462

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Recruiting

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Recruiting

  • NeuroCare Center

    Canton, Ohio, 44718

    Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

    Recruiting

  • Northwestern University Feinberg School Of Medicine

    Chicago, Illinois, 60611

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Recruiting

  • Parkinson's Research Centers of America - Long Island

    Commack, New York, 11725

    Recruiting

  • Texas Neurology PA

    Dallas, Texas, 75206

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27705

    Recruiting

  • Rocky Mountain Movement Disorders

    Englewood, Colorado, 80113

    Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

    Recruiting

  • Neurology Center of North Orange County

    Fullerton, California, 92835

    Recruiting

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Recruiting

  • UC San Diego

    La Jolla, California, 92037

    Recruiting

  • K2 - Villages

    Lady Lake, Florida, 32159

    Recruiting

  • Cleveland Clinic Lou Ruvo

    Las Vegas, Nevada, 89106

    Recruiting

  • Keck School of Medicine of USC

    Los Angeles, California, 900033

    Recruiting

  • UCLA Neurology Outpatient Clinic

    Los Angeles, California, 90095

    Recruiting

  • K2 Medical Research-Maitland

    Maitland, Florida, 32751

    Recruiting

  • Veracity Neuroscience

    Memphis, Tennessee, 38157

    Recruiting

  • Baptist Hospital of Miami

    Miami, Florida, 33176

    Recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

    Recruiting

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

    Recruiting

  • Weill Cornell Medical College

    New York, New York, 10021

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Recruiting

  • Charter Research - Winter Park/Orlando

    Orlando, Florida, 32803

    Recruiting

  • Advent Health Orlando

    Orlando, Florida, 32804

    Recruiting

  • Parkinson?s Research Centers of America ? Palo Alto

    Palo Alto, California, 94301

    Recruiting

  • Hackensack University Medical Center;Department of Neurology, Neuroscience Institute

    Paramus, New Jersey, 07652

    Recruiting

  • Profound Research LLC at The Neurology Center of Southern California

    Pasadena, California, 91105

    Recruiting

  • University Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Recruiting

  • Renown Health

    Reno, Nevada, 89502

    Recruiting

  • VCU Health North Hospital

    Richmond, Virginia, 23298

    Recruiting

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

    Recruiting

  • UCSF Weill Institute for Neurosciences

    San Francisco, California, 94158

    Recruiting

  • Avera Medical Group

    Sioux Falls, South Dakota, 57105

    Recruiting

  • Washington Uni School of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • Stanford Neuroscience Health Center (SNHC)

    Stanford, California, 94304

    Recruiting

  • USF Parkinsons Disease and Movement Disorders Center

    Tampa, Florida, 33613

    Recruiting

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136

    Recruiting

  • Georgetown University

    Washington D.C., District of Columbia, 20007

    Recruiting

Other trials in United States

China21 sites, 21 recruiting

  • Beijing Friendship Hospital Affiliated of Capital University of Medical Science

    Beijing, 100050

    Recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053

    Recruiting

  • Beijing Tian Tan Hospital,Capital Medical University

    Beijing, 100071

    Recruiting

  • Beijing Hospital of Ministry of Health

    Beijing, 100730

    Recruiting

  • The First Hospital of Jilin University

    Changchun, 130021

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, 610041

    Recruiting

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

    Recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510080

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, 510115

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 310009

    Recruiting

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou

    Recruiting

  • Nanjing Brain Hospital

    Nanjing, 210029

    Recruiting

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200025

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, 200040

    Recruiting

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200127

    Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, 300052

    Recruiting

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

    Recruiting

Other trials in China

Germany17 sites, 17 recruiting

  • Kliniken Beelitz GmbH

    Beelitz, 14547

    Recruiting

  • Charite Universitätsmed. Berlin

    Berlin, 10117

    Recruiting

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12203

    Recruiting

  • St. Josef-Hospital, Klinik für Neurologie

    Bochum, 44791

    Recruiting

  • Universitätsklinikum "Carl Gustav Carus"

    Dresden, 01307

    Recruiting

  • Heinrich-Heine Universitätsklinik Düsseldorf

    Düsseldorf, 40225

    Recruiting

  • Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie

    Erlangen, 91054

    Recruiting

  • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

    Freiburg im Breisgau, 79106

    Recruiting

  • Medizinische Hochschule Hannover, Klinik für Neurologie

    Hanover, 30625

    Recruiting

  • Universitätsklinikum Heidelberg, Neurologische Klinik, Abteilung für Neuroradiologie

    Heidelberg, 69120

    Recruiting

  • Universität Des Saarlandes

    Homburg, 66421

    Recruiting

  • Paracelsus Elena Klinik Kassel

    Kassel, 34128

    Recruiting

  • LMU Klinikum, Neurologische Klinik und Poliklinik

    München, 81377

    Recruiting

  • Klinikum rechts der Isar der TU München

    Munich, 81675

    Recruiting

  • Universitatsklinikum Munster

    Münster, 48149

    Recruiting

  • Universitaettsklinikum Tübingen

    Tübingen, 72076

    Recruiting

  • Universitätsklinikum Würzburg, Neurologische Klinik und Poliklinik

    Würzburg, 97080

    Recruiting

Other trials in Germany

Italy13 sites, 13 recruiting

  • Ospedale Bellaria

    Bologna, Emilia-Romagna, 40139

    Recruiting

  • Azienda Ospedaliera Spedali Civili

    Brescia, Lombardy, 25100

    Recruiting

  • San Raffaele Cassino

    Cassino, Lazio, 03043

    Recruiting

  • Irccs A.O.U.San Martino Ist

    Genoa, Liguria, 16132

    Recruiting

  • Centro Parkinson e Parkinsonismi

    Milan, Lombardy, 20126

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132

    Recruiting

  • IRCCS Istituto Neurologico Carlo Besta

    Milan, Lombardy, 20133

    Recruiting

  • Università degli studi della Campania Luigi Vanvitelli

    Naples, Campania, 80138

    Recruiting

  • Azienda Ospedaliera di Padova

    Padova, Veneto, 35128

    Recruiting

  • A.O. Universitaria Pisana

    Pisa, Tuscany, 56126

    Recruiting

  • IRCCS San Raffaele;Clinical Trial Center

    Rome, Lazio, 00166

    Recruiting

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

    Recruiting

  • Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona

    Salerno, Campania, 84131

    Recruiting

Other trials in Italy

Spain13 sites, 13 recruiting

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, LA Coruna, 15006

    Recruiting

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

    Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinic Barcelona

    Barcelona, 08036

    Recruiting

  • Policlinica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa, 20009

    Recruiting

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

    Recruiting

  • Hospital Ruber Juan Bravo

    Madrid, 28006

    Recruiting

  • Hospital Universitario de La Princesa

    Madrid, 28006

    Recruiting

  • Hospital Univ 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Regional Universitario de Malaga ? Hospital General

    Málaga, 29009

    Recruiting

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223

    Recruiting

  • Hospital General De Catalunya

    Sant Cugat del Vallès, Barcelona, 08195

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Recruiting

Other trials in Spain

France11 sites, 11 recruiting

  • Hospices Civils de Lyon - Hôpital Pierre Wertheimer

    Bron, Rhône, 69003

    Recruiting

  • CHU de Clermont-Ferrand - Site Gabriel-Montpied

    Clermont-Ferrand, 63000

    Recruiting

  • APHP - Hopital Henri Mondor

    Créteil, 94010

    Recruiting

  • CHU de Grenoble - Hôpital André Michallon

    La Tronche, 38700

    Recruiting

  • Hopital Roger Salengro

    Lille, 59037

    Recruiting

  • CHU de Limoges - Hôpital Dupuytren

    Limoges, 87042

    Recruiting

  • AP-HM- Hôpital de La Timone

    Marseille, Bouches-du-Rhône, 13005

    Recruiting

  • CHU de Montpellier - Hôpital Gui de Chauliac

    Montpellier, 34295

    Recruiting

  • CHU de Nice Hopital Pasteur

    Nice, 06002

    Recruiting

  • APHP - Hopital de la Pitie Salpetriere

    Paris, 75013

    Recruiting

  • CHU de Toulouse - Hôpital Purpan

    Toulouse, 31059

    Recruiting

Other trials in France

Poland10 sites, 9 recruiting

  • Podlaskie Centrum Psychogeriatrii

    Bia?ystok, 15-756

    Withdrawn

  • NZOZ Vitamed

    Bydgoszcz, 85-079

    Recruiting

  • Szpital Sw. Wojciecha

    Gda?sk, 80-462

    Recruiting

  • NEURO-CARE Sp. z o.o. Sp. Komandytowa

    Katowice, 40-749

    Recruiting

  • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

    Krakow, 31-505

    Recruiting

  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

    Lublin, 20-410

    Recruiting

  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

    Oświęcim, 32-600

    Recruiting

  • Nmedis sp. z o.o.

    Rzeszów, 35-232

    Recruiting

  • NeuroProtect

    Warsaw, 01-684

    Recruiting

  • Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.

    Warsaw, 03-242

    Recruiting

Other trials in Poland

Brazil8 sites, 8 recruiting

  • Hospital das Clinicas - UFMG

    Belo Horizonte, Minas Gerais, 31270-901

    Recruiting

  • L2 Ip Instituto de Pesquisas Clinicas Ltda ME

    Brasília, Federal District, 70200-730

    Recruiting

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310

    Recruiting

  • Núcleo de Pesquisa do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90430-001

    Recruiting

  • Faculdade de Medicina de Ribeirão Preto - Universidade de Sao Paulo

    Ribeirão Preto, São Paulo, 14051-140

    Recruiting

  • Santa Casa de Misericordia de Salvador

    Salvador, Estado de Bahia, 40050-410

    Recruiting

  • Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*

    São José do Rio Preto, São Paulo, 15090-000

    Recruiting

  • Centro de Pesquisas Clinicas

    São Paulo, São Paulo, 01228-200

    Recruiting

Other trials in Brazil

Australia7 sites, 7 recruiting

  • Monash Health

    Clayton, Victoria, 3168

    Recruiting

  • Southern Neurology

    Kogarah, New South Wales, 2217

    Recruiting

  • Perron Institute for Neurological and Translational Science

    Nedlands, Western Australia, 6009

    Recruiting

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

    Recruiting

  • The Alfred Hospital

    Prahan, Victoria, 3181

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Recruiting

Other trials in Australia

Portugal7 sites, 7 recruiting

  • Hospital de Braga

    Braga, 4710-243

    Recruiting

  • Hospital da Luz Coimbra

    Coimbra, 3020-479

    Recruiting

  • Hospital Dr. Nélio Mendonça;Serviço de Neurologia

    Funchal, 9004-514

    Recruiting

  • Hospital da Senhora da Oliveira-Guimarães

    Guimarães

    Recruiting

  • Hospital de Santa Maria

    Lisbon, 1649-035

    Recruiting

  • Hospital Pedro Hispano

    Matosinhos Municipality, 4464-513

    Recruiting

  • CNS - Campus Neurológico

    Torres Vedras, 2560-280

    Recruiting

Other trials in Portugal

United Kingdom7 sites, 7 recruiting

  • Ninewells Hospital, Dundee- Scotland

    Dundee, DD2 1SY

    Recruiting

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, EX2 5DW

    Recruiting

  • Royal London Hospital

    London, E1 1FR

    Recruiting

  • Charing Cross Hospital

    London, W6 8RF

    Recruiting

  • Campus for Ageing and Vitality

    Newcastle, NE4 5PL

    Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE

    Recruiting

  • Plymouth Hospitals NHS Trust - Derriford Hospital

    Plymouth,Devon, PL6 8DH

    Recruiting

Other trials in United Kingdom

South Korea6 sites, 6 recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Boramae Medical Center

    Seoul, 07061

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Recruiting

  • Seoul National University Hospital

    Seoul, 110-744

    Recruiting

Other trials in South Korea

Taiwan6 sites, 6 recruiting

  • Changhua Christian Hospital

    Changhua County, 500

    Recruiting

  • China Medical University Hospital

    North Dist., 40447

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan City, 333

    Recruiting

Other trials in Taiwan

Austria5 sites, 4 recruiting

  • Medizinische Universität Graz

    Graz, 8036

    Recruiting

  • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck

    Innsbruck, 6020

    Recruiting

  • Kepler Universitätsklinikum GmbH - Neuromed Campus

    Linz, 4020

    Recruiting

  • Medizinische Universität Wien

    Vienna, 1090

    Withdrawn

  • Klinik Ottakring

    Vienna, 1160

    Recruiting

Other trials in Austria

Canada3 sites, 3 recruiting

  • CHUM

    Montreal, Quebec, H2X 0A9

    Recruiting

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4

    Recruiting

  • University Health Network

    Toronto, Ontario, M5G 2C4

    Recruiting

Other trials in Canada

Denmark3 sites, 3 recruiting

  • Aarhus Universitetshospital Skejby

    Aarhus N, 8200

    Recruiting

  • Regionshospitalet Gødstrup;Neurologisk Afdeling

    Herning, 7400

    Recruiting

  • Bispebjerg Hospital;Neurologisk Afdeling

    København NV, 2400

    Recruiting

Other trials in Denmark

Mexico2 sites, 2 recruiting

  • Instituto Nacional de Neurologia y Neurocirugia

    Mexico City, Mexico CITY (federal District), 14390

    Recruiting

  • Hospital General de Mexico

    Mexico City, Mexico CITY (federal District), 6726

    Recruiting

Other trials in Mexico

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early-Stage Parkinson's Disease

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.

Being tested
Prasinezumab, Placebo
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrasinezumabDrug

    Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.

  • PlaceboDrug

    Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol

Study groups in NCT07174310
Study groupRoleWhat they receive
PrasinezumabExperimentalParticipants 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.
Receives: Drug: Prasinezumab
PlaceboExperimentalParticipants will receive placebo as an IV Infusion.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score

    Measured: Up to at least Week 104

Secondary outcomes (11)

  1. Change From Baseline in Motor Function as Measured by the MDS-UPDRS Part III off Medication Score

    Measured: Baseline, Week 104

  2. Time to Worsening of Participants Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event

    Measured: Up to at least Week 104

  3. Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C), Overall Disease Subscale

    Measured: Up to at least Week 104

  4. Time to increase in Levodopa Equivalent Daily Dose (LEDD)

    Measured: Up to at least Week 104

  5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

    Measured: From Baseline up to 70 days after the final study dose (up to at least Week 104)

  6. Percentage of Participants With Adverse Events of Special Interest (AESI)

    Measured: From Baseline up to 70 days after the final study dose (up to at least Week 104)

  7. Percentage of Participants With Infusion Related Reactions (IRRs)

    Measured: From Baseline up to 70 days after the final study dose (up to at least Week 104)

  8. Percentage of Participants With Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Measured: From Baseline up to 70 days after the final study dose (up to at least Week 104)

  9. Serum Concentration of Prasinezumab

    Measured: 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)

  10. Percentage of Participants With Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline

    Measured: At Baseline

  11. Percentage of Participants With ADAs Against Prasinezumab During the Study

    Measured: From Baseline up to 70 days after the final study dose (up to at least Week 104)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2025
  2. Study start24 Nov 2025
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07174310
Sponsor's protocol ID
BN44715
Other IDs
2025-522683-32-00, 2025
Acronym
PARAISO
Status last verified
Oct 2026
First submitted
12 Sep 2025
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 42208564

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prasinezumab in people with Parkinson's Disease, run by Hoffmann-La Roche at 192 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in United States, China, Germany, Italy, Spain and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score (time frame: Up to at least Week 104). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07174310, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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PARAISO Clinical Trial NCT07174310 | AzTrials