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NCT03100149Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 11 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
316 (actual)
First submitted
29 Mar 2017
Start date
27 Jun 2017
Primary completion date
27 Nov 2019
Lead sponsor
Hoffmann-La Roche
NCT number
NCT03100149
EU CT number
2023-504472-24-00
EudraCT number
2017-000087-15

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 316
  • From 27 Jun 2017 to the primary completion date, 27 Nov 2019
  • 52 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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
  • Donation of blood over 500 milliliters (mL) within three months prior to screening

Other illness

  • 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
  • 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
  • History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality
  • Any significant cardiovascular condition
  • 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.

Lab values

  • Any significant laboratory abnormality

Other

  • Known carriers of certain familial PD genes (as specified in study protocol)
  • Mini Mental State Examination (MMSE) \</=25
  • Reside in a nursing home or assisted care facility
  • Lactating women
  • 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

Who the study is looking for

  • 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.

Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (52)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyRecruiting
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA
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KasselGermanyRecruiting
Universitaet Leipzig
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LeipzigGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Policlinica Gipuzkoa S.A.
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DonostiaSpainActive, not recruiting
Hospital Universitario de la Princesa
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MadridSpainActive, not recruiting
Hospital Universitario Fundacion Alcorcon
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MadridSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitari General de Catalunya
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Sant Cugat del VallèsSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Pellegrin Hospital
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BordeauxFranceRecruiting
Chu Gabriel Montpied
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Clermont-FerrandFranceRecruiting
Assistance Publique Hopitaux De Paris
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Creteil CedexFranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceRecruiting
Hôpital de la Timone
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Marseille Cedex 5FranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceRecruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceRecruiting
Aventura Neurologic Associates
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AventuraUnited StatesUnknown status
Uab Medicine
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BirminghamUnited StatesUnknown status
Parkinson's Disease and Movement Disorders Center of Boca Raton
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Boca RatonUnited StatesUnknown status
Beth Israel Deaconess Medical Center
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BostonUnited StatesUnknown status
University of Vermont Medical Center
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BurlingtonUnited StatesUnknown status
CenExel Rocky Mountain Clinical Research, LLC
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EnglewoodUnited StatesUnknown status
Northwestern University
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EvanstonUnited StatesUnknown status
Associated Neurologists of Southern CT PC
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FairfieldUnited StatesUnknown status
QUEST Research Institute
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Farmington HillsUnited StatesUnknown status
Neurology Center of North Orange County
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FullertonUnited StatesUnknown status
Corewell Health Neurology and Epilepsy - Beltline
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Grand RapidsUnited StatesUnknown status
Baylor College
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HoustonUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
USC Keck Medical Center of USC
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Los AngelesUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Molecular Neurolmaging
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New HavenUnited StatesUnknown status
Columbia University
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New YorkUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Barrow Neurology Clinics
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PhoenixUnited StatesUnknown status
Oregon Health & Science Uni
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PortlandUnited StatesUnknown status
University of Rochester Medical Center
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RochesterUnited StatesUnknown status
Central Texas Neurology Consultants
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Round RockUnited StatesUnknown status
University of California at San Francisco
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San FranciscoUnited StatesUnknown status
USF Parkinsons Disease and Movement Disorders Center
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TampaUnited StatesUnknown status
The Movement Disorder Clinic of Oklahoma
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TulsaUnited StatesUnknown status
Henry Ford Health System
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West BloomfieldUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.