---
title: "A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease"
euct_id: 2023-507132-21-00
eudra_ct_number: 2020-004997-23
status: Recruiting
sponsor: F. Hoffmann-La Roche AG
canonical_url: "https://parkinsonspathways.com/trials/eu/2023-507132-21-00"
eu_clinical_trials_register: "https://euclinicaltrials.eu/ctis-public/view/2023-507132-21-00"
ctis_last_updated: "2026-04-14T03:35:58.496598803"
source: EU Clinical Trials Information System (CTIS)
---
# A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease

**EU CT Number:** [2023-507132-21-00](https://euclinicaltrials.eu/ctis-public/view/2023-507132-21-00)

## Key Facts

- **Status:** Recruiting
- **Sponsor:** F. Hoffmann-La Roche AG
- **Start Date:** 2021-08-24
- **Completion Date:** 2031-06-30
- **Conditions:** Early Parkinson's disease, Parkinson's disease
- **Interventions:** RO7046015, RO7046015 Placebo

## Member States

Trial is authorized in 6 member states: Austria, France, Italy, Luxembourg, Poland, Spain.

## Sites (68)

- Medizinische Universitaet Innsbruck, Innsbruck, Austria
- Stadt Wien Wiener Gesundheitsverbund, Vienna, Austria
- Medical University Of Graz, Graz, Austria
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
- Azienda Ospedaliera di Padova, Padova, Italy
- Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona, Salerno, Italy
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli, Naples, Italy
- Azienda Unita Sanitaria Locale Di Bologna, Bologna, Italy
- Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania, Catania, Italy
- Istituto Neurologico Mediterraneo Neuromed S.p.A., Pozzilli, Italy
- Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
- IRCCS Ospedale Policlinico San Martino, Genoa, Italy
- Irccs San Raffaele Roma S.r.l., Rome, Italy
- IRCCS Foundation Istituto Neurologico Carlo Besta, Milan, Italy
- Hospital Santa Maria Della Misericordia, Perugia, Italy
- Ospedale San Raffaele S.r.l., Milan, Italy
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Brescia, Italy
- Azienda Ospedaliera S Maria Di Terni, Terni, Italy
- Nmedis Sp. z o.o., Rzeszow, Poland
- NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki, Lodz, Poland
- Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKP, Warsaw, Poland
- Indywidualna Praktyka Lekarska  Prof. dr hab. n. med. Konrad Rejdak, Lublin, Poland
- Centrum Medyczne Neuroprotect, Warsaw, Poland
- Copernicus Podmiot Leczniczy Sp. z o.o., Gdansk, Poland
- Vitamed Galaj I Cichomski Sp. j., Bydgoszcz, Poland
- Mazowiecki Szpital Brodnowski Sp. z o.o., Warsaw, Poland
- Krakowska Akademia Neurologii Sp. z o.o., Cracow, Poland
- Hospital Universitario De Burgos, Burgos, Spain
- Hospital Universitari General De Catalunya, Sant Cugat Del Valles, Spain
- Hospital Universitario Quironsalud Madrid, Pozuelo De Alarcon, Spain
- Hospital Clinic De Barcelona, Barcelona, Spain
- Hospital General Universitario De Elche, Elche, Spain
- Clinica Universidad De Navarra, Pamplona, Spain
- Hospital Universitario De La Princesa, Madrid, Spain
- Hospital Universitario De Cruces, Barakaldo, Spain
- Hospital Universitario Virgen De La Macarena, Sevilla, Spain
- Clinica Montecanal S.L., Zaragoza, Spain
- Policlinica Gipuzkoa S.A., Donostia, Spain
- Hospital Universitario Hm Puerta Del Sur, Mostoles, Spain
- Hospital Universitario Y Politecnico La Fe, Valencia, Spain
- University Hospital Virgen Del Rocio S.L., Sevilla, Spain
- Hospital Universitario Dr Peset Aleixandre, Valencia, Spain
- Hospital General Universitario Gregorio Maranon, Madrid, Spain
- Hospital De La Santa Creu I Sant Pau, Barcelona, Spain
- Complexo Hospitalario Universitario A Coruna, A Coruna, Spain
- Hospital Clinico San Carlos, Madrid, Spain
- Hospital Universitari Vall D Hebron, Barcelona, Spain
- Hospital Virgen Del Puerto, Plasencia, Spain
- Hospital Ruber Juan Bravo, Madrid, Spain
- Hospital Universitario Fundacion Alcorcon, Alcorcon, Spain
- Hospital Universitario 12 De Octubre, Madrid, Spain
- Hospital Universitario Regional De Malaga, Malaga, Spain
- Centre Hospitalier Et Universitaire De Limoges, Limoges Cedex 1, France
- Centre Hospitalier Universitaire De Poitiers, Poitiers, France
- Les Hopitaux Universitaires De Strasbourg, Strasbourg Cedex 2, France
- Assistance Publique Hopitaux De Paris, Paris, France
- Centre Hospitalier Universitaire De Toulouse, Toulouse, France
- Centre Hospitalier Universitaire De Montpellier, Montpellier Cedex 5, France
- Centre Hospitalier Universitaire De Nice, Nice, France
- Centre Hospitalier Universitaire De Nantes, Saint Herblain, France
- Centre Hospitalier Universitaire De Bordeaux, Bordeaux, France
- Hospices Civils De Lyon, Bron, France
- Centre Hospitalier Universitaire Rouen, Rouen Cedex, France
- Assistance Publique Hopitaux De Paris, Creteil, France
- Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 9, France
- University Hospital Of Clermont-Ferrand, Clermont Ferrand Cedex 1, France
- Centre Hospitalier Regional De Marseille, Marseille, France
- Centre Hospitalier De Luxembourg, Luxembourg, Luxembourg

## Eligibility (CTIS)

- **Minimum age:** 18 Years
- **Sex:** ALL

```
Condition: Early Parkinson's disease; Parkinson's disease
Age groups: adults 18-64, elderly 65+
Sex: male, female
Includes a vulnerable population.

Period: Screening
The screening phase will last up to 12 weeks. Patients who are candidates for
enrollment in the study will be evaluated by the investigator to ensure that all eligibility
criteria are met (see Sections 4.1.1 and 4.1.2). All patients must have signed the
Informed Consent Form prior to screening and prior to any changes to their existing
medication for the purposes of enrollment in the study.

Period: Double-Blind Treatment
The double-blind treatment period will last for at least 76 weeks for all participants and
will continue until a minimum of 248 participants experience a confirmed motor
progression event. All study participants will continue to receive double-blind study
treatment until both of these conditions are fulfilled (i.e., participants who reach the
confirmed motor progression event will continue to receive double-blind study treatment
until at least 248 events have occurred and until approximately 575 participants have
completed at least 76 weeks of study treatment)

Period: Double-Blind Treatment End-of-Study Visit or Double-Blind Treatment Early Termination
At the end of the double-blind period, all patients will be asked to return to the clinic to
complete final efficacy and safety assessments 28 days ( 7 days) following their final
dose (end-of-study visit).
All patients who discontinue treatment or withdraw from the study early (during the
double-blind treatment period) will be asked to return approximately 28 days (  7 days)
after the final dose of study drug in order to complete the early termination visit.
In addition, patients who discontinue treatment will be asked to return for collection of
safety and efficacy data according to the schedule of activities (Appendix 1) until the end
of the double-blind treatment period. These patients will also be asked to participate in
end-of-study and safety follow-up visits.
Autopsy reports, including cause of death, for all patients who die during the study
(i.e., prior to the safety follow-up visit) should be requested.
See the schedule of activities (Appendix 1) for information about the assessments that
should be performed upon study completion at the end-of-study or early termination visit

Period: Open Label Extension
The OLE is a 2-year extension in which all participants will receive treatment.
Participants and sites will remain blinded to prior treatment assignment until the end of
the OLE period.
Prasinezumab—F. Hoffmann-La Roche Ltd
51/Protocol BN42358, Version 4
Prior to the double-blind treatment end-of-study visit, participants will be asked about
their interest in joining the OLE. In order to join the OLE, participants must have
completed the double-blind treatment period, must be deemed eligible and must have
consented to participate in the OLE. Should the participants meet these requirements,
and once all the double-blind treatment end-of-study visit assessments have been
completed, the participants will be given the first dose of prasinezumab in the OLE
period. Participants will continue with Q4W dosing of prasinezumab for 104 weeks.

Period: Safety Follow-Up
All participants will be asked to come back for a safety follow-up visit after the end of the
double-blind treatment period (for participants not enrolling in the OLE), or at the end of
the OLE (for participants enrolling in the OLE) (see Appendix 1).
When patients complete the end-of-study visit or the early termination visit, every effort
should be made to ensure that the safety follow-up visit and all related assessments
are completed.
After the end-of-study visit or early termination visit, adverse events should be recorded
as outlined in Sections 5.5 and 5.6.
See the schedule of activities (Appendix 1) for the list of assessments to be performed at
the safety follow-up visit.
```

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