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Could an antibody slow Parkinson's? new trial hopes to find out

NCT ID NCT03100149

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests an experimental drug called prasinezumab in 316 people with early Parkinson's disease. The drug is an antibody designed to target and remove clumps of a protein linked to Parkinson's. Participants receive either the drug or a placebo for 52 weeks, with an option to continue treatment for up to 11 more years. The goal is to see if the drug can slow the worsening of symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

316 people

The number who actually took part.

Started

Jun 2017

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson's disease

Contacts and locations

Locations

  • Associated Neurologists of Southern CT PC

    Fairfield, Connecticut, 06824, United States

  • Aventura Neurologic Associates

    Aventura, Florida, 33180, United States

  • Barrow Neurology Clinics

    Phoenix, Arizona, 85013, United States

  • Baylor College

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CHU Poitiers

    Poitiers, 86021, France

  • CHU Rouen Charles Nicolle

    Rouen, 76031, France

  • CHU de Nantes - Hopital Laennec

    Saint-Herblain, 44800, France

  • CHU de Nice Hopital Pasteur

    Nice, 06002, France

  • CIC - Hôpital Purpan

    Toulouse, 31059, France

  • CenExel Rocky Mountain Clinical Research, LLC

    Englewood, Colorado, 80113, United States

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681, United States

  • Clinica Universidad de Navarra

    Pamplona/iruña, Navarre, 31008, Spain

  • Columbia University

    New York, New York, 10032, United States

  • Corewell Health Neurology and Epilepsy - Beltline

    Grand Rapids, Michigan, 49525, United States

  • DZNE Clinical Trial Unit

    München, 81377, Germany

  • Fundacion Hospital de Alcorcon

    Alcorcón, Madrid, 28922, Spain

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33000, France

  • Heinrich-Heine Universitätsklinik Düsseldorf

    Düsseldorf, 40225, Germany

  • Henry Ford Health System

    West Bloomfield, Michigan, 48322, United States

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63003, France

  • Hopital Henri Mondor

    Créteil, 94010, France

  • Hopital Pitie-Salpetriere APHP

    Paris, 75013, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08195, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario de la Princesa

    Madrid, 28006, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025, Spain

  • Hôpital Michallon - Centre d'Investigation Clinique

    Grenoble, 38043, France

  • Klinik fur Neurologie

    Berlin, 10117, Germany

  • Klinik und Poliklinik für Neurologie Universitätsklinikum

    Leipzig, 04103, Germany

  • Medizinische Universität Innsbruck

    Innsbruck, 6020, Austria

  • Molecular Neurolmaging

    New Haven, Connecticut, 06510, United States

  • Neurology Center of North Orange County

    Fullerton, California, 92835, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Oregon Health & Science Uni

    Portland, Oregon, 97239, United States

  • Paracelsus Elena Klinik Kassel

    Kassel, 34128, Germany

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

    Boca Raton, Florida, 33486, United States

  • Philipps Universität Marburg

    Marburg, 35043, Germany

  • Policlínica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa, 20014, Spain

  • Quest Research Institute

    Farmington Hills, Michigan, 48334, United States

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136, United States

  • UNIVERSITY of PENNSYLVANIA

    Philadelphia, Pennsylvania, 19107, United States

  • USC Keck Medical Center of USC

    Los Angeles, California, 90033, United States

  • USF Parkinsons Disease and Movement Disorders Center

    Tampa, Florida, 33613, United States

  • Uab Medicine

    Birmingham, Alabama, 35233, United States

  • Universitaettsklinikum Tübingen

    Tübingen, 72076, Germany

  • University of California at San Francisco

    San Francisco, California, 94115, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Rochester Medical Center

    Rochester, New York, 14618, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • hopital de la Timone

    Marseille, 13385, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.