A study comparing prasinezumab with placebo for people with early-stage Parkinson’s disease

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What is this study about?

This study is looking at Early-Stage Parkinson’s Disease, which is a condition that affects movement and can cause symptoms such as slowness of movement, trembling at rest, and muscle stiffness. The study will test a treatment called prasinezumab, which is also known by the code name RO7046015. This medication is a type of antibody that is designed to target a specific protein involved in Parkinson’s Disease. Some participants will receive prasinezumab while others will receive placebo. The purpose of the study is to compare how well prasinezumab works compared with placebo in slowing down the worsening of movement problems in people with early-stage Parkinson’s Disease.

Participants in this study will have been diagnosed with Parkinson’s Disease and will already be taking medication for their condition for at least three months. The study will look at whether prasinezumab can delay the time it takes for movement problems to get worse. Prasinezumab will be given through an intravenous infusion, which means it will be delivered directly into a vein. The study will measure various aspects of how participants move and function, including detailed assessments of motor function, which refers to how well a person can control their body movements.

During the study, doctors will carefully monitor participants for any side effects or unwanted reactions to the treatment. This includes checking for infusion-related reactions, which are responses that can happen when medication is given through a vein. Regular health checks will be performed, including measurements of vital signs such as blood pressure and heart rate, blood tests, and assessments of overall wellbeing. The study will also track changes in the amount of Parkinson’s Disease medication that participants need to take over time, as well as how participants feel about changes in their condition.

1 Initial assessment and confirmation

Your diagnosis of Parkinson’s disease will be confirmed based on specific criteria established by the Movement Disorder Society. This means your condition must include bradykinesia (slowness of movement) plus at least one other main sign such as resting tremor (shaking when muscles are relaxed) or rigidity (stiffness).

Your current stage of Parkinson’s disease will be assessed using the Hoehn and Yahr scale, which measures disease progression. You must be at Stage 1 or 2 when not taking medication, indicating early-stage disease.

Your score on the MDS-UPDRS Part IV assessment, which evaluates motor complications, must be 0. This means you should not have motor complications from your current treatment.

You must have been taking Parkinson’s disease medication for at least 3 months before starting the study.

2 Randomization and treatment assignment

You will be randomly assigned to receive either prasinezumab or placebo. The placebo is an inactive substance that looks identical to the actual medication but contains no active ingredient.

Neither you nor your medical team will know which treatment you are receiving. This is called a double-blind study design and helps ensure accurate results.

3 Treatment administration

You will receive your assigned treatment through an intravenous infusion, which means the medication will be delivered directly into your vein through a needle.

The infusion will be given at regular intervals throughout the study period.

4 Regular monitoring and assessments

Your motor function will be regularly assessed using the MDS-UPDRS Part III scale. This evaluation measures movement-related symptoms when you are not taking your regular Parkinson’s medication.

The medical team will monitor for any motor progression events, which means a confirmed worsening of your movement symptoms.

Your vital signs, including blood pressure, heart rate, and temperature, will be measured at each visit.

Blood samples will be taken at specific times to check various laboratory parameters, including hematology (blood cell counts), clinical chemistry (chemical components in blood), coagulation (blood clotting ability), and urinalysis (urine tests).

An electrocardiogram (ECG) will be performed to monitor your heart’s electrical activity.

You will be assessed for any suicidal thoughts or behaviors using the Columbia Suicide Severity Rating Scale.

The medical team will monitor for any side effects or adverse reactions, including infusion-related reactions that may occur during or after the treatment administration.

5 Week 104 assessment

At Week 104 (approximately 2 years after starting), a comprehensive assessment of your motor function will be conducted using the MDS-UPDRS Part III score while you are off your regular medication.

Changes in your motor function from the beginning of the study will be evaluated.

6 Ongoing evaluations throughout the study

Your self-reported motor function will be assessed to determine if there is any worsening.

The Clinical Global Impression of Change (CGI-C) Overall Disease Subscale will be used to evaluate meaningful changes in your overall condition.

Any increases in your LEDD (levodopa equivalent daily dose), which measures the total amount of Parkinson’s medication you take, will be monitored.

Blood samples will be collected at specified times to measure the concentration of prasinezumab in your blood and to check for anti-drug antibodies, which are proteins your immune system might produce in response to the medication.

7 Contraception requirements

You must follow specific contraception requirements throughout the study period as agreed upon at the start.

8 Study completion

The study is expected to continue until July 2031, though your individual participation duration may vary.

Throughout the entire study period, any adverse events will be classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, which provides a standardized way to describe the severity of side effects.

Who Can Join the Study?

  • You must have a diagnosis of idiopathic Parkinson’s Disease, which means Parkinson’s Disease that occurs on its own without a known cause, confirmed by specific medical criteria. Your diagnosis must include bradykinesia (slowness of movement) plus at least one other main sign such as resting tremor (shaking when your muscles are relaxed) or rigidity (muscle stiffness).
  • You must have been taking medication for Parkinson’s Disease for at least 3 months before starting the study.
  • You must have a score of 0 on a specific rating scale called MDS-UPDRS Part IV at the screening visit and before being assigned to a treatment group. This scale measures complications related to Parkinson’s Disease treatment.
  • You must be at Hoehn and Yahr Stage 1 or 2 when not taking your medication during the screening visit and before being assigned to a treatment group. This staging system describes how severe your Parkinson’s Disease symptoms are, with Stage 1 and 2 being early stages of the disease.
  • You must agree to follow the required contraception (birth control) methods during the study.

Who Cannot Join the Study?

  • You have a type of parkinsonism (a movement disorder similar to Parkinson’s disease) that is caused by medications, genetic conditions, or other brain diseases
  • You have had brain surgery for Parkinson’s disease, such as deep brain stimulation (a treatment where electrodes are placed in the brain to help control symptoms)
  • You have significant memory problems or dementia (a condition that affects memory and thinking abilities)
  • You have a history of psychosis (a mental condition where you see or hear things that are not real or have unusual beliefs)
  • You have other serious brain or nerve conditions besides Parkinson’s disease
  • You have uncontrolled high blood pressure or heart disease
  • You have serious liver or kidney problems
  • You have active cancer or have been treated for cancer in the recent past
  • You have a history of serious infections or immune system problems
  • You are pregnant, breastfeeding, or planning to become pregnant during the study
  • You have had a serious allergic reaction to medications similar to the study drug
  • You are taking certain medications that could interfere with the study treatment
  • You have participated in another clinical trial recently
  • You have any other medical condition that the doctor believes would make it unsafe for you to participate

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Kliniken Beelitz GmbH Beelitz Germany
Mazowiecki Szpital Brodnowski Sp. z o.o. Warsaw Poland
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Hospital Universitario 12 De Octubre Madrid Spain
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Milan Italy
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Policlinica Gipuzkoa S.A. Donostia / San Sebastian Spain
Vitamed Galaj I Cichomski Sp. j. Bydgoszcz Poland
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA Kassel Germany
Brain Research Center Amsterdam B.V. Amsterdam The Netherlands
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Brain Research Center Zwolle B.V. Zwolle The Netherlands
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona Salerno Italy
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Revit Sp. z o.o. Bialystok Poland
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
Ruhr University Bochum Germany
CNS Saude Lda. Torres Vedras Portugal
Servico de Saude da Regiao Autonoma Da Madeira EPERAM Funchal Portugal
Irccs San Raffaele Roma S.r.l. Rome Italy
Azienda Ospedaliera di Padova Padua Italy
Brain Research Center Den Bosch B.V. s-Hertogenbosch The Netherlands
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Saarland University Hospital Homburg Germany
IRCCS Ospedale Policlinico San Martino Genoa Italy
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital Ruber Juan Bravo Madrid Spain
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Neuroprotect Sp. z o.o. Warsaw Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Nnsvdg Scp z ocnp Rzeszow Poland
Hdbiosrt Ucffgpfwrraxq Dq Lf Ppbpekfq Madrid Spain
Nqlulgwouq Stz z ondd sqliw Katowice Poland
Coplat Hkeksdryqzp Ez Ugrzhdzjechtd Dd Lppoacw Limoges France
Aivteqtyft Pmadvkfc Hytwgkbx Dv Msjdygsfv Marseille France
Ubownqzadkattbesfibxe Dtvcdtaotjj Ash Duesseldorf Germany
Bkhuklez Usuveccntk Hysvpgkg Culwcm Besançon France
Ujkrwxwckraqiwksvlwxp Mwjwrnky Alp Munster Germany
Ropgsz Mnynyfpexba Herning Denmark
Kvwnrhxm dsb Ukulmhcksqnv Miutgesm Avh Munich Germany
Uegyftneqpuafspdxurnz Wnliedqhm Avq Wuerzburg Germany
Jkvapwuh Kcizsn Uzgirqrcoj Linz Austria
Hoasxtfu Vnnx dhhoykye Barcelona Spain
Idluzaxt Zzclopo Dd Bmxdncswlxkfzuoyv Oświęcim Poland
Hqdpcphz Uigeekidodlsl dn A Cforbz A Coruna Galicia Spain
Ihkjtxemhpsr Pbwfegxo Lqvavtip Pdoxf df hoag nj mdtk Kcwinj Rxgtcz Lublin Poland
Hyvdwzca da Lay Clzzpdsa Sqwz Coimbra Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
31.12.2025
Denmark Denmark
Recruiting
31.12.2025
France France
Not yet recruiting
31.12.2025
Germany Germany
Recruiting
31.12.2025
Italy Italy
Recruiting
31.12.2025
Poland Poland
Recruiting
31.12.2025
Portugal Portugal
Recruiting
31.12.2025
Spain Spain
Recruiting
31.12.2025
The Netherlands The Netherlands
Not yet recruiting
31.12.2025

Trial locations

Investigated drugs:

Prasinezumab is an experimental medication given through an intravenous infusion (directly into a vein). It is being tested to see if it can help slow down the progression of early-stage Parkinson’s disease. This medication is designed to target a specific protein that may be involved in the disease process.

Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare against prasinezumab to help determine if the actual medication is working.

Investigated diseases:

Early-Stage Parkinson’s Disease – Parkinson’s disease is a brain disorder that affects movement and gets worse over time. In the early stage, symptoms are mild and may include slight tremors, small changes in handwriting, or reduced arm swing when walking. The disease develops when certain nerve cells in the brain that produce dopamine, a chemical messenger important for controlling movement, gradually break down or die. As the condition progresses, movements become slower and more difficult, and muscles may become stiff. People may also notice balance problems and changes in their posture. The early stage is the period when symptoms are present but have not yet significantly impacted daily activities.

Trial ID:
2025-522683-32-00
Protocol code:
BN44715
Trial Phase:
Therapeutic confirmatory (Phase III)

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