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Parkinson's DiseasePhase 2PASADENANCT03100149

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

A Phase 2 study testing RO7046015 in people with Parkinson's Disease, run by Hoffmann-La Roche at 55 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
RO7046015
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
316 participants
Where
55 sitesin 5 countries
Study dates
27 Jun 2017to 1 Dec 2031
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 26Show fewer
  • 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

Trial locations and contacts

55 sites in 5 countries.

55 sites in 5 countries

United States26 sites

  • Aventura Neurologic Associates

    Aventura, Florida, 33180

  • Uab Medicine

    Birmingham, Alabama, 35233

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

    Boca Raton, Florida, 33486

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • CenExel Rocky Mountain Clinical Research, LLC

    Englewood, Colorado, 80113

  • Northwestern University

    Evanston, Illinois, 60208

  • Associated Neurologists of Southern CT PC

    Fairfield, Connecticut, 06824

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Corewell Health Neurology and Epilepsy - Beltline

    Grand Rapids, Michigan, 49525

  • Baylor College

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • USC Keck Medical Center of USC

    Los Angeles, California, 90033

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Molecular Neurolmaging

    New Haven, Connecticut, 06510

  • Columbia University

    New York, New York, 10032

  • UNIVERSITY of PENNSYLVANIA

    Philadelphia, Pennsylvania, 19107

  • Barrow Neurology Clinics

    Phoenix, Arizona, 85013

  • Oregon Health & Science Uni

    Portland, Oregon, 97239

  • University of Rochester Medical Center

    Rochester, New York, 14618

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • University of California at San Francisco

    San Francisco, California, 94115

  • USF Parkinsons Disease and Movement Disorders Center

    Tampa, Florida, 33613

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136

  • Henry Ford Health System

    West Bloomfield, Michigan, 48322

Other trials in United States

France11 sites

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33000

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63003

  • Hopital Henri Mondor

    Créteil, 94010

  • Hôpital Michallon - Centre d'Investigation Clinique

    Grenoble, 38043

  • hopital de la Timone

    Marseille, 13385

  • CHU de Nice Hopital Pasteur

    Nice, 06002

  • Hopital Pitie-Salpetriere APHP

    Paris, 75013

  • CHU Poitiers

    Poitiers, 86021

  • CHU Rouen Charles Nicolle

    Rouen, 76031

  • CHU de Nantes - Hopital Laennec

    Saint-Herblain, 44800

  • CIC - Hôpital Purpan

    Toulouse, 31059

Other trials in France

Spain9 sites

  • Fundacion Hospital de Alcorcon

    Alcorcón, Madrid, 28922

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Policlínica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Clinica Universidad de Navarra

    Pamplona/iruña, Navarre, 31008

  • Hospital General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08195

  • Hospital Universitario Virgen Macarena

    Seville, 41009

Other trials in Spain

Germany8 sites

  • Klinik fur Neurologie

    Berlin, 10117

  • Heinrich-Heine Universitätsklinik Düsseldorf

    Düsseldorf, 40225

  • Paracelsus Elena Klinik Kassel

    Kassel, 34128

  • Klinik und Poliklinik für Neurologie Universitätsklinikum

    Leipzig, 04103

  • Philipps Universität Marburg

    Marburg, 35043

  • DZNE Clinical Trial Unit

    München, 81377

  • Universitaettsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Austria1 site

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

Other trials in Austria

About this study

Official 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

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.

Being tested
RO7046015, 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.

  • RO7046015Drug

    Also called PRX002; prasinezumab

    RO7046015 will be administered at dose of 4500 milligrams (mg) for participants with body-weight greater than or equal to (>/=) 65 kilograms (kg) or 3500 mg for participants with body-weight less than (<) 65 kg.

  • RO7046015Drug

    Also called PRX002; prasinezumab

    RO7046015 will be administered at dose of 1512 mg to all participants in the indicated arm.

  • PlaceboDrug

    RO7046015 placebo will be administered to all participants in the indicated arm.

Study groups in NCT03100149
Study groupRoleWhat they receive
Part 1: RO7046015 High DoseExperimentalParticipants will receive RO7046015 at high dose level as intravenous (IV) infusion every 4 weeks (Q4W) up to 52 weeks in Part 1.
Receives: Drug: RO7046015
Part 1: RO7046015 Low DoseExperimentalParticipants will receive RO7046015 at low dose level as IV infusion Q4W up to 52 weeks in Part 1.
Receives: Drug: RO7046015
Part 1: PlaceboPlacebo comparatorParticipants will receive placebo as IV infusion Q4W up to 52 weeks in Part 1.
Receives: Drug: Placebo
Part 2: RO7046015 High DoseExperimentalPart 1 RO7046015 high dose group participants and placebo group participants randomized to high dose level will receive RO7046015 at high dose level as IV infusion Q4W for additional 52 weeks in Part 2.
Receives: Drug: RO7046015
Part 2: RO7046015 Low DoseExperimentalPart 1 RO7046015 low dose group participants and placebo group participants randomized to low dose level will receive RO7046015 at low dose level as IV infusion Q4W for additional 52 weeks in Part 2.
Receives: Drug: RO7046015
Part 3: RO7046015 Low DoseExperimentalAll participants who complete Part 1 and Part 2 will receive monthly IV infusions of RO7046015.
Receives: Drug: RO7046015

What is being measured

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

  1. Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52

    The MDS-UPDRS is a multimodal scale consisting of four parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contains 6 questions and are assessed by the examiner (Range 0-24). Part IB contains 7 questions on non-motor experiences of daily living which was completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of Parkinson's Disease (PD) and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. The MDS-UPDRS Total Score equals the sum of Parts I,II, and III (Range: 0-236). A higher score indicated more severe symptoms of Parkinson's disease.

    Measured: From baseline to Week 52

Secondary outcomes (15)

  1. Change From Baseline in the MDS-UPDRS Part IA, Part IB, Part I Total, Part II Total, Part III Total and Part III Subscores

    The MDS-UPDRS is a multimodal scale consisting of four parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contains 6 questions and are assessed by the examiner (Range 0-24). Part IB contains 7 questions on non-motor experiences of daily living which was completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of Parkinson's Disease (PD) and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. There are 4 subscores in Part III: Bradykinesia, Rigidity, Resting tremors and Axial symptoms. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I,II, and III (Range:0-236). A higher score indicated more severe symptoms of Parkinson's disease.

    Measured: From baseline to Week 52

  2. Change From Baseline in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Striatal Binding Ratio (SBR) in the Putamen Ipsilateral to the Clinically Most Affected Side

    DaT-SPECT (dopamine transporter imaging with single photon emission computed tomography) is a dopamine transporter SPECT imaging that uses a radioactive agent called 123^I-ioflupane to quantify the density of the dopamine transporters in the striatum. Changes from baseline to week 52 in DaT-SPECT striatal binding ratios (SBRs; reference region: occipital cortex) in the putamen ipsilateral to the clinically most affected side were analyzed.

    Measured: From baseline to Week 52

  3. Change From Baseline in Montreal Cognition Assessment (MoCA) Total Score

    The Montreal Cognitive Assessment (MoCA) is a rapid screening that was developed to be more sensitive to participants presenting with mild cognitive complaints. It briefly assesses short term and working memory, visuospatial abilities, executive function, attention, concentration, language and orientation. Scores on the MoCA test range from 0-30. Higher scores are associated with better cognitive function.

    Measured: From baseline to Week 52

  4. Change From Baseline in Clinical Global Impression of Improvement (CGI-I) Score

    The CGI-I was intended as a measure of change in health status. CGI-I scores ranged from 1 (very much improved) through to 7 (very much worse). For the CGI-I, participants were divided into one of two groups, Responders or Progressors. Responders were scored on a scale of 1-4 which was rated as "no change", "minimally improved", "much improved" or "very much improved." Progressors were scored on a scale of 5-7 which was rated as "minimally worse", "much worse" or "very much worse." The percentage of participants rated by CGI-I Scale grouping at week 52 was analyzed using a logistic regression model.

    Measured: From baseline to Week 52

  5. Change From Baseline in Patient Global Impression of Change (PGIC) Score

    The PGIC was intended as a measure of change in health state from the participants perspective. PGIC scores ranged from 1 (very much improved) through to 7 (very much worse). For the PGIC, participants were divided into one of two groups, Responders or Progressors. Responders were scored on a scale of 1-4 which was rated as "no change", "minimally improved", "much improved" or "very much improved." Progressors were scored on a scale of 5-7 which was rated as "minimally worse", "much worse" or "very much worse." The percentage of participants rated by PGIC Scale grouping at week 52 was analyzed using a logistic regression model.

    Measured: From baseline to Week 52

  6. Change From Baseline in Schwab and England Activity of Daily Living (SE-ADL) Score

    The SE-ADL is a single item scale assessing Activities of Daily Living on a scale ranging from 0% (bedridden) to 100% (completely independent), using 10% intervals.

    Measured: From baseline to Week 52

  7. Time to Worsening in Motor or Non-Motor Symptoms

    This outcome measure is defined as the time to between first dose of study medication and the date when the particiapnt increases in MDS-UPDRS Part I (Range 0-52) of 3 or more points, or in MDS-UPDRS Part II (Range 0-52) of 3 or more points, whichever comes first. A higher score indicated more severe motor signs of Parkinson's disease.

    Measured: From baseline to Week 52

  8. Time to Start of Dopaminergic Parkinson's Disease Treatment

    This endpoint is defined as the time between first dose of study medication and the date when the participant starts dopaminergic treatment.

    Measured: From baseline to Week 52

  9. Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was any AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Measured: From baseline to Week 52

  10. Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7046015

    Samples of the participant's blood was taken to evaluate anti-drug antibodies (ADA). The number of ADA positive participants, Treatment-induced and Treatment-enhanced was reported. Treatment-induced = participants with ADA negative or missing data at baseline but develop an ADA response following exposure to the study drug. Treatment-enhanced = participants with ADA positive at baseline and the titre of one or more post-baseline samples is at least >=4 fold increase greater than the baseline titre sample.

    Measured: Baseline, Pre-dose (0 hours) on Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116)

  11. Systemic Clearance (CL) of RO7046015

    Clearance is a measure of the rate at which a drug is removed from the body.

    Measured: Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Baseline, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116)

  12. Apparent Volume of Distribution (Vz/F) of RO7046015

    Volume of distribution is defined as the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

    Measured: Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Baseline, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116)

  13. Area Under the Serum Concentration-Time Curve (AUC) of RO7046015 Over the Dosing Interval

    AUC is defined as the measure of RO7046015 plasma concentration over time.

    Measured: Baseline over the duration of the study

  14. Maximum Observed Serum Concentration (Cmax) of RO7046015 at Steady-state

    Cmax is the maximum observed plasma concentration of RO7046015.

    Measured: Baseline over the duration of the study

  15. Minimum Observed Serum Concentration (Ctrough) of RO7046015 at Steady-state

    Cmin is the minimum observed plasma concentration of RO7046015.

    Measured: Baseline over the duration of the study

Timeline

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

  1. First posted4 Apr 2017
  2. Study start27 Jun 2017
  3. Primary completion27 Nov 2019
  4. Study completion1 Dec 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
316 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03100149
Sponsor's protocol ID
BP39529
Other IDs
2017-000087-15, 2023-504472-24-00, 2023, 2017
Acronym
PASADENA
Status last verified
Sep 2026
First submitted
29 Mar 2017
Last updated
11 Sep 2026
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

  • Coles D, Kalyana A, Khalil S, Chauhan D, Rupasinghe T, Costello C, Batla A, Young T. The Efficacy and Safety of Monoclonal Antibodies That Target Alpha-Synuclein in Parkinson's Disease: A Systematic Review. Parkinsons Dis. 2026 Jul 22;2026:8540084. doi: 10.1155/padi/8540084. eCollection 2026.

    PubMed 42495570

  • 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.

    PubMed 40523921

  • 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.

    PubMed 39379705

  • 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.

    PubMed 35921451

  • 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.

    PubMed 35840753

  • 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.

    PubMed 34659081

  • 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.

    PubMed 29913017

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RO7046015 in people with Parkinson's Disease, run by Hoffmann-La Roche at 55 sites in 5 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 10 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, France, Spain, Germany, Austria. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52 (time frame: From baseline to Week 52). 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 NCT03100149, which also lists 7 linked publications.

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 11 Sep 2026.

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