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In progress; recruitment closed · registry status

A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease

A plain-language introduction is being prepared for this study. Open it to read the original description, who can join and how to contact the team.

Testing a treatment or activity · Study reference: NCT03100149

The registry title is shown while an English plain-language introduction is prepared. Read the original details below ↓

Open the official registry record ↗

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Results reported

Registries report different stages for this study. Check the source records below and confirm with the team.

Start (reported actual date)
2017-06-27
Main measurements finished (reported actual date)
2019-11-27
Study finished (planned)
2031-12-01

Planned dates can move. A study finishing does not tell us when a paper will be published.

Read the results reported in the registry ↗

Changes we have recorded
  • 2026-10-11 — active not recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

The Efficacy and Safety of Monoclonal Antibodies That Target Alpha-Synuclein in Parkinson's Disease: A Systematic Review.
Listed by the registry as research derived from the study · 2026

Taylor KI, Lipsmeier F, Scelsi MA, Volkova-Volkmar E, Rukina D, Popp W, Lambrecht S, Anzures-Cabrera J, Summers D, Abt M, Monnet A, Kilchenmann T, Schjodt-Eriksen J, Essioux L, Kustermann T, Zago W, Svoboda H, Nikolcheva T, Postuma RB, Pagano G, Lindemann M; PASADENA Investigators; Prasinezumab Study Group. Exploratory digital outcome measures of motor sign progression in Parkinson's disease patients treated with prasinezumab. NPJ Digit Med. 2025 Jun 16;8(1):365. doi: 10.1038/s41746-025-01572-8. ↗
Registry derived research reference

Pagano G, Monnet A, Reyes A, Ribba B, Svoboda H, Kustermann T, Simuni T, Postuma RB, Pavese N, Stocchi F, Brockmann K, Smigorski K, Gerbaldo V, Fontoura P, Doody R, Kerchner GA, Brundin P, Marek K, Bonni A, Nikolcheva T; PASADENA Investigators; Prasinezumab Study Group. Sustained effect of prasinezumab on Parkinson's disease motor progression in the open-label extension of the PASADENA trial. Nat Med. 2024 Dec;30(12):3669-3675. doi: 10.1038/s41591-024-03270-6. Epub 2024 Oct 8. ↗
Registry derived research reference

Pagano G, Taylor KI, Anzures-Cabrera J, Marchesi M, Simuni T, Marek K, Postuma RB, Pavese N, Stocchi F, Azulay JP, Mollenhauer B, Lopez-Manzanares L, Russell DS, Boyd JT, Nicholas AP, Luquin MR, Hauser RA, Gasser T, Poewe W, Ricci B, Boulay A, Vogt A, Boess FG, Dukart J, D'Urso G, Finch R, Zanigni S, Monnet A, Pross N, Hahn A, Svoboda H, Britschgi M, Lipsmeier F, Volkova-Volkmar E, Lindemann M, Dziadek S, Holiga S, Rukina D, Kustermann T, Kerchner GA, Fontoura P, Umbricht D, Doody R, Nikolcheva T, Bonni A; PASADENA Investigators; Prasinezumab Study Group. Trial of Prasinezumab in Early-Stage Parkinson's Disease. N Engl J Med. 2022 Aug 4;387(5):421-432. doi: 10.1056/NEJMoa2202867. ↗
Registry derived research reference

Lipsmeier F, Taylor KI, Postuma RB, Volkova-Volkmar E, Kilchenmann T, Mollenhauer B, Bamdadian A, Popp WL, Cheng WY, Zhang YP, Wolf D, Schjodt-Eriksen J, Boulay A, Svoboda H, Zago W, Pagano G, Lindemann M. Reliability and validity of the Roche PD Mobile Application for remote monitoring of early Parkinson's disease. Sci Rep. 2022 Jul 15;12(1):12081. doi: 10.1038/s41598-022-15874-4. ↗
Registry derived research reference

Pagano G, Boess FG, Taylor KI, Ricci B, Mollenhauer B, Poewe W, Boulay A, Anzures-Cabrera J, Vogt A, Marchesi M, Post A, Nikolcheva T, Kinney GG, Zago WM, Ness DK, Svoboda H, Britschgi M, Ostrowitzki S, Simuni T, Marek K, Koller M, Sevigny J, Doody R, Fontoura P, Umbricht D, Bonni A; PASADENA Investigators; Prasinezumab Study Group. A Phase II Study to Evaluate the Safety and Efficacy of Prasinezumab in Early Parkinson's Disease (PASADENA): Rationale, Design, and Baseline Data. Front Neurol. 2021 Oct 1;12:705407. doi: 10.3389/fneur.2021.705407. eCollection 2021. ↗
Registry derived research reference

Jankovic J, Goodman I, Safirstein B, Marmon TK, Schenk DB, Koller M, Zago W, Ness DK, Griffith SG, Grundman M, Soto J, Ostrowitzki S, Boess FG, Martin-Facklam M, Quinn JF, Isaacson SH, Omidvar O, Ellenbogen A, Kinney GG. Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-alpha-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 1;75(10):1206-1214. doi: 10.1001/jamaneurol.2018.1487. ↗
Registry derived research reference

Participation rules recorded for this study

Ages 40 years to 80 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: * Idiopathic PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD untreated or treated with MAO-B inhibitor * Body weight range between: \>/=45 kg/ 99 pounds (lbs) and less than or equal to (\</=) 110 kg/242 lbs * Body mass index (BMI) of 18 to 34 kilograms per meter-squared (kg/m\^2) * A diagnosis of PD for 2 years or less at screening * Hoehn and Yahr Stage I or II * A screening brain DaT-SPECT consistent with PD (central reading) * Clinical status does not require dopaminergic PD medication and is not expected to require dopaminergic treatment within 52 weeks from baseline * If presently being treated for PD, a stable dose of MAO-B inhibitor (rasagiline or selegiline) for at least 90 days prior to baseline and not expected to change within 52 weeks * For women of childbearing potential: use of highly effective contraceptive methods (that result in a failure rate of \<1 percent \[%\] per year) during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug * For men with female partners of childbearing potential or pregnant female partners, must use a condom during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The female partners should use a contraception method with a failure rate of \<1% per year during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug. Use of contraceptive measures is not required for male participants enrolled in Part 3. Exclusion Criteria: * Medical history indicating a Parkinson syndrome other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia * Known carriers of certain familial PD genes (as specified in study protocol) * History of PD related freezing episodes or falls * A diagnosis of a significant CNS disease other than Parkinson's disease; history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child * Mini Mental State Examination (MMSE) \</=25 * Reside in a nursing home or assisted care facility * History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality * Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study or interfere with the participant's ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data * Any significant cardiovascular condition * Any significant laboratory abnormality * Lactating women * Prior treatment with dopaminergic medication (for example, levodopa or a dopaminergic agonist) with no clinical treatment response or a clinical treatment response inconsistent with PD (for example, absence of observable response to a sufficiently high-dose of levodopa \[i.e., ≥ 600 mg/day\]) * Use of any of the following: catechol-O-methyl transferase (COMT) inhibitors (entacapone, tolcapone), amantadine or anticholinergics, or dopaminergic medication (levodopa and both ergot and non-ergot \[pramipexole, ropinirole, rotigotine\] dopamine agonists) for more than a total of 60 days or within 60 days of baseline * Anti-epileptic medication for non-seizure-related treatment which has not remained stable for at least 60 days prior to baseline * Anti-depressant or anxiolytic use that has not remained stable for at least 90 days prior to baseline. The use of fluoxetine and fluvoxamine is not permitted. For patients treated with a MAO-B inhibitor and an antidepressant (except fluoxetine and fluvoxamine), a 6-month period of stable and tolerated dosing before baseline is required. * Use of any of the following within 90 days prior to baseline: antipsychotics (including clozapine and olanzapine), metoclopramide, alpha methyldopa, clozapine, olanzapine, flunarizine, amoxapine, amphetamine derivatives, reserpine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, and modafinil * Participated in an investigational drug, device, surgical , or stem cell study in PD * Any prior treatment with an investigational PD-related vaccine (including active immunization or passive immunotherapy with monoclonal antibodies). * Prior participation in any RO7046015 or PRX002 study * Receipt of any non-PD investigational product or device, or participation in a non-PD drug research study within a period of 30 days (or 5 half-lives of the drug, whichever is longer) before baseline * Receipt of any monoclonal antibody or an investigational immunomodulator within 180 days (or 5 half-lives, whichever is longer) before baseline * Immunomodulating drugs within 30 days prior to baseline * Allergy to any of the components of RO7046015 such as citrate, trehalose and polysorbate (Tween) 20 or a known hypersensitivity or an Infusion-related reaction (IRR) to the administration of any other monoclonal antibody * Any contraindications to obtaining a brain MRI. Patients with a hypersensitivity to iodine may receive an alternative thyroid blocking agent. * For participants consenting to provide optional cerebrospinal fluid (CSF) samples by lumbar puncture (LP): LP will only be performed if the participant does not have any contraindication to undergoing an LP * Donation of blood over 500 milliliters (mL) within three months prior to screening
Full study name & original research details

Official study title

A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants With Early Parkinson's Disease With a 11-Year All-Participants-on-Treatment Extension

Short title used by the registry

A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease

Original description

This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in participants with early Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhibitors since baseline. The study will consist of three parts: a 52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part 2). Participants who complete Part 2 (including the 12-week treatment-free follow up visit assessing long term safety and efficacy of RO7046015) will be offered participation in Part 3 open-label extension (all-participants-on-RO7046015-treatment) for an additional 520 weeks.

Conditions reported: Parkinson's Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
RO7046015; RO7046015; Placebo
Phases
PHASE2
Sponsor
Hoffmann-La Roche
Start date reported by registry
2017-06-27 (actual)

Registry updated: 2026-09-11 · Status last verified by the registry submitter: 2026-09

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

No central contact is listed. Check the location contacts or the official registry record.

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Uab Medicine

Birmingham, Alabama, United States

Status not reported

Barrow Neurology Clinics

Phoenix, Arizona, United States

Status not reported

Neurology Center of North Orange County

Fullerton, California, United States

Status not reported

USC Keck Medical Center of USC

Los Angeles, California, United States

Status not reported

University of California at San Francisco

San Francisco, California, United States

Status not reported

CenExel Rocky Mountain Clinical Research, LLC

Englewood, Colorado, United States

Status not reported

Associated Neurologists of Southern CT PC

Fairfield, Connecticut, United States

Status not reported

Molecular Neurolmaging

New Haven, Connecticut, United States

Status not reported

Aventura Neurologic Associates

Aventura, Florida, United States

Status not reported

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Status not reported

USF Parkinsons Disease and Movement Disorders Center

Tampa, Florida, United States

Status not reported

Northwestern University

Evanston, Illinois, United States

Status not reported

University of Kansas Medical Center

Kansas City, Kansas, United States

Status not reported

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Status not reported

Quest Research Institute

Farmington Hills, Michigan, United States

Status not reported

Corewell Health Neurology and Epilepsy - Beltline

Grand Rapids, Michigan, United States

Status not reported

Henry Ford Health System

West Bloomfield, Michigan, United States

Status not reported

Columbia University

New York, New York, United States

Status not reported

University of Rochester Medical Center

Rochester, New York, United States

Status not reported

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States

Status not reported

Oregon Health & Science Uni

Portland, Oregon, United States

Status not reported

UNIVERSITY of PENNSYLVANIA

Philadelphia, Pennsylvania, United States

Status not reported

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Status not reported

Baylor College

Houston, Texas, United States

Status not reported

Central Texas Neurology Consultants

Round Rock, Texas, United States

Status not reported

University of Vermont Medical Center

Burlington, Vermont, United States

Status not reported

Medizinische Universität Innsbruck

Innsbruck, Austria

Status not reported

Groupe Hospitalier Pellegrin

Bordeaux, France

Status not reported

Hopital Gabriel Montpied

Clermont-Ferrand, France

Status not reported

Hopital Henri Mondor

Créteil, France

Status not reported

Hôpital Michallon - Centre d'Investigation Clinique

Grenoble, France

Status not reported

hopital de la Timone

Marseille, France

Status not reported

CHU de Nice Hopital Pasteur

Nice, France

Status not reported

Hopital Pitie-Salpetriere APHP

Paris, France

Status not reported

CHU Poitiers

Poitiers, France

Status not reported

CHU Rouen Charles Nicolle

Rouen, France

Status not reported

CHU de Nantes - Hopital Laennec

Saint-Herblain, France

Status not reported

CIC - Hôpital Purpan

Toulouse, France

Status not reported

Klinik fur Neurologie

Berlin, Germany

Status not reported

Heinrich-Heine Universitätsklinik Düsseldorf

Düsseldorf, Germany

Status not reported

Paracelsus Elena Klinik Kassel

Kassel, Germany

Status not reported

Klinik und Poliklinik für Neurologie Universitätsklinikum

Leipzig, Germany

Status not reported

Philipps Universität Marburg

Marburg, Germany

Status not reported

DZNE Clinical Trial Unit

München, Germany

Status not reported

Universitaettsklinikum Tübingen

Tübingen, Germany

Status not reported

Universitätsklinikum Ulm

Ulm, Germany

Status not reported

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Status not reported

Policlínica Guipuzcoa

Donostia / San Sebastian, Guipuzcoa, Spain

Status not reported

Fundacion Hospital de Alcorcon

Alcorcón, Madrid, Spain

Status not reported

Clinica Universidad de Navarra

Pamplona/iruña, Navarre, Spain

Status not reported

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Status not reported

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Status not reported

Hospital Clinic de Barcelona

Barcelona, Spain

Status not reported

Hospital Universitario de la Princesa

Madrid, Spain

Status not reported

Hospital Universitario Virgen Macarena

Seville, Spain

Status not reported

Assistance Publique Hopitaux De Paris

Creteil Cedex, France

Recruiting

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble Cedex 9, France

Recruiting

Centre Hospitalier Universitaire De Poitiers

Poitiers, France

Recruiting

CHU Gabriel-Montpied

Clermont Ferrand, France

Recruiting

Pellegrin Hospital

Bordeaux, France

Recruiting

Hôpital de la Timone

Marseille Cedex 5, France

Recruiting

Centre Hospitalier Universitaire De Toulouse

Toulouse, France

Recruiting

Assistance Publique Hopitaux De Paris

Paris, France

Recruiting

Centre Hospitalier Universitaire De Nice

Nice, France

Recruiting

Centre Hospitalier Universitaire De Nantes

Saint Herblain, France

Recruiting

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Recruiting

Universitaet Leipzig

Leipzig, Germany

Recruiting

Paracelsus-Kliniken Deutschland GmbH & Co. KGaA

Kassel, Germany

Recruiting

Universitaetsklinikum Tuebingen AöR

Tuebingen, Germany

Recruiting

Universitaetsklinikum Ulm AöR

Ulm, Germany

Recruiting

Universitaetsklinikum Duesseldorf AöR

Duesseldorf, Germany

Recruiting

Charite Universitaetsmedizin Berlin KöR

Berlin, Germany

Recruiting

Hospital Universitario De La Princesa

Madrid, Spain

Recruiting

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain

Recruiting

Hospital Universitario Virgen De La Macarena

Sevilla, Spain

Recruiting

Clinica Universidad De Navarra

Pamplona, Spain

Recruiting

Hospital Universitario Fundacion Alcorcon

Madrid, Spain

Recruiting

Hospital Universitari General De Catalunya

Sant Cugat Del Valles, Spain

Recruiting

Hospital Clinic De Barcelona

Barcelona, Spain

Recruiting

Hospital Universitari Vall D Hebron

Barcelona, Spain

Recruiting

Policlinica Gipuzkoa S.A.

Donostia, Spain

Recruiting

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.