--- title: "A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (PASADENA)" euct_id: 2023-504472-24-00 eudra_ct_number: 2017-000087-15 phase: Phase 4 status: Recruiting sponsor: F. Hoffmann-La Roche AG canonical_url: "https://parkinsonspathways.com/trials/eu/2023-504472-24-00" eu_clinical_trials_register: "https://euclinicaltrials.eu/ctis-public/view/2023-504472-24-00" ctis_last_updated: "2026-05-13T03:33:25.667408299" source: EU Clinical Trials Information System (CTIS) --- # A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (PASADENA) **EU CT Number:** [2023-504472-24-00](https://euclinicaltrials.eu/ctis-public/view/2023-504472-24-00) ## Key Facts - **Phase:** Phase 4 - **Status:** Recruiting - **Sponsor:** F. Hoffmann-La Roche AG - **Start Date:** 2017-12-15 - **Completion Date:** 2026-04-23 - **Conditions:** Early Idiopathic Parkinson’s disease (PD), Parkinson's disease - **Interventions:** RO7046015 ## Member States Trial is authorized in 4 member states: Austria, France, Germany, Spain. ## Sites (26) - Assistance Publique Hopitaux De Paris, Creteil Cedex, France - Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 9, France - Centre Hospitalier Universitaire De Poitiers, Poitiers, France - CHU Gabriel-Montpied, Clermont Ferrand, France - Pellegrin Hospital, Bordeaux, France - Hôpital de la Timone, Marseille Cedex 5, France - Centre Hospitalier Universitaire De Toulouse, Toulouse, France - Assistance Publique Hopitaux De Paris, Paris, France - Centre Hospitalier Universitaire De Nice, Nice, France - Centre Hospitalier Universitaire De Nantes, Saint Herblain, France - Medizinische Universitaet Innsbruck, Innsbruck, Austria - Universitaet Leipzig, Leipzig, Germany - Paracelsus-Kliniken Deutschland GmbH & Co. KGaA, Kassel, Germany - Universitaetsklinikum Tuebingen AöR, Tuebingen, Germany - Universitaetsklinikum Ulm AöR, Ulm, Germany - Universitaetsklinikum Duesseldorf AöR, Duesseldorf, Germany - Charite Universitaetsmedizin Berlin KöR, Berlin, Germany - Hospital Universitario De La Princesa, Madrid, Spain - Hospital De La Santa Creu I Sant Pau, Barcelona, Spain - Hospital Universitario Virgen De La Macarena, Sevilla, Spain - Clinica Universidad De Navarra, Pamplona, Spain - Hospital Universitario Fundacion Alcorcon, Madrid, Spain - Hospital Universitari General De Catalunya, Sant Cugat Del Valles, Spain - Hospital Clinic De Barcelona, Barcelona, Spain - Hospital Universitari Vall D Hebron, Barcelona, Spain - Policlinica Gipuzkoa S.A., Donostia, Spain ## Eligibility (CTIS) - **Minimum age:** 18 Years - **Sex:** ALL ``` Condition: Early Idiopathic Parkinson’s disease (PD); Parkinson's disease Age groups: elderly 65+, adults 18-64 Sex: male, female Includes a vulnerable population. Period: Part 1 During Part 1 of the study, participants will receive IV infusions of RO7046015 or placebo once every four weeks (Q4W) over a period of 52 weeks. Participants will be randomized with a 1:1:1 allocation ratio to placebo, or one of the two active treatment doses: high dose (4500 mg for body weight  65 kg; 3500 mg for body weight  65 kg), low dose (1500 mg; for all body weights). Randomization will be stratified by sex, age group and existence or lack of prior background therapy (untreated or treated with stable MAO-B inhibitor therapy at baseline). Participants are expected not to start dopaminergic therapy (levodopa or dopamine agonist) or other symptomatic PD therapy during the 52-week double-blind placebo-controlled period. Some participants may experience worsening of their symptoms to an extent that they are unable to tolerate in their personal or professional life. These participants may start dopaminergic or symptomatic PD treatment according to local guidelines after completing the assessments at the “prior to start of dopaminergic or symptomatic PD treatment” visit according to the schedule of assessments and the Investigator must record the reasons and the type and dose of dopaminergic or symptomatic PD treatment started. For the main analysis of the primary endpoint and other efficacy endpoints that are sensitive to dopaminergic treatment (such as MDS-UPDRS part III, PGIC, CGI-I), only data up to the last measurement before start of symptomatic PD treatment will be used. Data after start of symptomatic PD treatment will be included in safety, sensitivity, exploratory and biomarker evaluations as appropriate. All participants, including those that have started symptomatic PD treatment, will be eligible to participate in Part 2 if they have completed Part 1 with the predefined minimum of infusions and assessments as defined below. Period: Part 2 Part 2 is a one-year all-participants-on-treatment, blinded to dose extension. Participants must meet the following criteria to enter Part 2: DaT-SPECT and magnetic resonance imaging (MRI) scans completed at Screening and Week 52 and received at least 10 doses of study treatment (RO7046015 or Placebo) during Part 1 of the study. Participants may initiate or change symptomatic PD treatment (including dopaminergic treatment) as per standard of care (SOC) during Part 2. For Part 2, participants who complete the initial placebo-controlled part and fulfil the criteria mentioned above will switch into the extension: RO7046015/prasinezumab —F. Hoffmann-La Roche Ltd 16/Protocol BP39529, Version 7  Participants initially randomized to placebo will be re-randomized to one of the two active doses using a 1:1 allocation ratio. Randomization will be stratified by: dopaminergic therapy since start of the study (Yes versus No), age group ( 60 versus  60) and prior background therapy with MAO-B inhibitor (Yes versus No). Note that for age group and prior background therapy with MAO-B inhibitor the values collected for Part 1 will be used.  Participants initially randomized to the active dose will remain on their dose. Period: Part 3 Part 3 is a 5-year open-label extension in which all participants will receive the same RO7046015 dose of 1500 mg (for all body weights) Q4W. Participants must meet the following criteria to enter Part 3:  Having completed Part 2 (i.e., completed Week 104 visit plus the 12-week treatment free follow-up). Note: Participants will still be eligible to enroll in part 3 if they missed assessments or visits due to COVID-19 related restrictions but they completed 12-week Treatment-Free Follow-Up Visit (12-week treatment-free follow-up can be completed remotely if not possible in person).  Participants may initiate or change symptomatic PD treatment (including dopaminergic treatment) as per standard of care during Part 3.  Not having received another investigational medication during the treatment free period (i.e., between Week 104 visit and Part 3 Week 1 visit).  Participation in Part 3 not deemed inappropriate by the Investigator (e.g., patient with serious medical condition or other concerns that preclude their safe participation in Part 3 or their ability to comply with the required procedures should not be enrolled). ``` --- *Canonical: https://parkinsonspathways.com/trials/eu/2023-504472-24-00* *HTML version: https://parkinsonspathways.com/trials/eu/2023-504472-24-00* *Source data: https://euclinicaltrials.eu/ctis-public/view/2023-504472-24-00*