Clinical trial • Phase II • Neurology
PRASINEZUMAB for Parkinson's disease (early idiopathic)
Phase II trial of PRASINEZUMAB for Parkinson's disease (early idiopathic).
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Parkinson's disease (early idiopathic)
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 21-12-2023
- First CTIS Authorization Date
- 19-03-2024
Trial design
Randomised, open-label, placebo intravenous infusion q4w (placebo arm) versus ro7046015 (prasinezumab) two active dose arms: high dose — 4500 mg for body weight ≥ 65 kg or 3500 mg for body weight < 65 kg, iv once every four weeks (q4w); low dose — 1500 mg iv q4w.-controlled Phase II trial across 26 sites in Austria, France, Germany and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Placebo intravenous infusion Q4W (placebo arm) versus RO7046015 (prasinezumab) two active dose arms: high dose — 4500 mg for body weight ≥ 65 kg or 3500 mg for body weight < 65 kg, IV once every four weeks (Q4W); low dose — 1500 mg IV Q4W.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 214
- Trial Duration For Participant
- 364
Stratification factors
- Sex
- Age group
- Prior background therapy with MAO-B inhibitor (untreated vs treated)
- Dopaminergic therapy since start of study (Yes vs No)
Eligibility
Recruits 214 Vulnerable population selected (isVulnerablePopulationSelected = true); no details on consent or assent handling are provided in the available record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true); no details on consent or assent handling are provided in the available record.
Inclusion criteria
- {"criterion_text":"- A screening brain DaT-SPECT consistent with PD (central reading)\n- Clinical status does not require dopaminergic PD medication and is not expected to require dopaminergic treatment within 52 weeks from baseline\n- 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.\n- 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\n- A diagnosis of PD for 2 years or less at screening\n- Hoehn and Yahr Stage I or II"}
Exclusion criteria
- {"criterion_text":"- 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\n- Mini Mental State Examination (MMSE) </=25\n- History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality\n- 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\n- Known carriers of certain familial PD genes (as specified in study protocol)\n- History of PD related freezing episodes or falls"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Change in total MDS-UPDRS score (sum of Parts I, II and III) from baseline at Week 52.","definition_or_measurement_approach":"Change from baseline at Week 52, measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (sum of Parts I, II and III)."}
Secondary endpoints
- {"endpoint_text":"- 1. Change from baseline in MDS-UPDRS Part IA, Part IB, Part I total, Part II total, Part III total and Part III subscores","definition_or_measurement_approach":"Change from baseline in specified MDS-UPDRS parts and subscores."}
- {"endpoint_text":"- 2. Change from baseline in Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) in ipsilateral (to the clinically dominant side) putamen","definition_or_measurement_approach":"Change from baseline in DaT-SPECT uptake in the ipsilateral putamen (to the clinically-dominant side)."}
- {"endpoint_text":"- 3. Change from baseline in Montreal Cognitive Assessment (MoCA) total score","definition_or_measurement_approach":"Change from baseline in total MoCA score."}
- {"endpoint_text":"- 4. Change from baseline in Clinical Global Impression (CGI-I)","definition_or_measurement_approach":"Change from baseline in CGI-Improvement score."}
- {"endpoint_text":"- 5. Change from baseline in Patient Global Impression of change (PGIC)","definition_or_measurement_approach":"Change from baseline in PGIC."}
- {"endpoint_text":"- 6. Change from baseline in Schwab and England Activities of Daily Living (SE-ADL)","definition_or_measurement_approach":"Change from baseline in SE-ADL score."}
- {"endpoint_text":"- 7. Time to worsening in motor or non-motor symptoms as measured in MDS-UPDRS","definition_or_measurement_approach":"Time-to-event endpoint: time to worsening as determined by MDS-UPDRS measures."}
- {"endpoint_text":"- 8. Time to start of dopaminergic PD treatment (levodopa or dopamine-agonists)","definition_or_measurement_approach":"Time-to-event: time from baseline to initiation of dopaminergic PD treatment (levodopa or dopamine agonists)."}
- {"endpoint_text":"- 9. Incidence and severity of adverse events (AEs) and serious AEs (SAEs)","definition_or_measurement_approach":"Incidence and severity assessment of AEs and SAEs as reported during the study."}
- {"endpoint_text":"- 10. Incidence of Anti-drug antibodies (ADAs)","definition_or_measurement_approach":"Incidence of detected anti-drug antibodies during treatment."}
- {"endpoint_text":"- 11. Population and individual primary PK parameter estimations","definition_or_measurement_approach":"Population and individual pharmacokinetic parameter estimations (PK analysis)."}
Recruitment
- Registry Or Advocacy Recruitment
- True, Michael J. Fox Foundation (MJFF)
- Digital Remote Recruitment
- True; recruitment/participant materials include web resources (Site web PASADENA, Site web MJFF), smartphone ICF and video/tablet instruction materials as indicated by document titles.
- Planned Sample Size
- 214
- Recruitment Window Months
- 100
- Consent Approach
- Subject information sheets and informed consent forms (L1 SIS and ICF) are provided; translated/document versions present for French and Spanish in the document list. No explicit details on assent, age-specific documents, or exact consent provider processes are provided in the available record.
Geography
- Total Number Of Sites
- 26
- Total Number Of Participants
- 238
Austria
- Earliest CTIS Part Ii Submission Date
- 07-12-2023
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 746
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Department of Neurology
- Principal Investigator Name
- Klaus Seppi
- Principal Investigator Email
- klaus.seppi@i-med.ac.at
- Contact Person Name
- Klaus Seppi
- Contact Person Email
- klaus.seppi@i-med.ac.at
France
- Earliest CTIS Part Ii Submission Date
- 23-02-2024
- Latest Decision Or Authorization Date
- 24-10-2025
- Processing Time Days
- 609
- Number Of Sites
- 10
- Number Of Participants
- 92
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Centre d’Investigation Clinique Henri Mondor
- Principal Investigator Name
- Philippe REMY
- Principal Investigator Email
- neuro.philippe.remy@aphp.fr
- Contact Person Name
- Philippe REMY
- Contact Person Email
- neuro.philippe.remy@aphp.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- CIC 406 – Centre d’Investigation Clinique (CIC)
- Principal Investigator Name
- Elena MORO
- Principal Investigator Email
- e.moro@chu-grenoble.fr
- Contact Person Name
- Elena MORO
- Contact Person Email
- e.moro@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Centre d’Investigation Clinique
- Principal Investigator Name
- Isabelle BENATRU
- Principal Investigator Email
- isabelle.benatru@chu-poitiers.fr
- Contact Person Name
- Isabelle BENATRU
- Contact Person Email
- isabelle.benatru@chu-poitiers.fr
- Site Name
- CHU Gabriel-Montpied
- Department Name
- Service de Neurologie
- Principal Investigator Name
- Ana Raquel MARQUES
- Principal Investigator Email
- ar_marques@chu-clermontferrand.fr
- Contact Person Name
- Ana Raquel MARQUES
- Contact Person Email
- ar_marques@chu-clermontferrand.fr
- Site Name
- Pellegrin Hospital
- Department Name
- Centre d’Investigation Clinique
- Principal Investigator Name
- Wassilios MEISSNER
- Principal Investigator Email
- wassilios.meissner@chu-bordeaux.fr
- Contact Person Name
- Wassilios MEISSNER
- Contact Person Email
- wassilios.meissner@chu-bordeaux.fr
- Site Name
- Hôpital de la Timone
- Department Name
- Service de Neurologie et pathologie du mouvement
- Principal Investigator Name
- Jean-Philippe AZULAY
- Principal Investigator Email
- jean-philippe.azulay@ap-hm.fr
- Contact Person Name
- Jean-Philippe AZULAY
- Contact Person Email
- jean-philippe.azulay@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Centre d’Investigation Clinique – CIC 1436
- Principal Investigator Name
- Olivier RASCOL
- Principal Investigator Email
- olivier.rascol@univ-tlse3.fr
- Contact Person Name
- Olivier RASCOL
- Contact Person Email
- olivier.rascol@univ-tlse3.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- CIC Neurosciences, Bâtiment ICM
- Principal Investigator Name
- Jean-Christophe CORVOL
- Principal Investigator Email
- jean-christophe.corvol@psl.aphp.fr
- Contact Person Name
- Jean-Christophe CORVOL
- Contact Person Email
- jean-christophe.corvol@psl.aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Service de Neurologie
- Principal Investigator Name
- Caroline BAYREUTHER-GIORDANA
- Principal Investigator Email
- bayreuther.c@chu-nice.fr
- Contact Person Name
- Caroline BAYREUTHER-GIORDANA
- Contact Person Email
- bayreuther.c@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- CIC, Service de Neurologie
- Principal Investigator Name
- Philippe DAMIER
- Principal Investigator Email
- philippe.damier@chu-nantes.fr
- Contact Person Name
- Philippe DAMIER
- Contact Person Email
- philippe.damier@chu-nantes.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 07-12-2023
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 887
- Number Of Sites
- 6
- Number Of Participants
- 65
Sites
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Joseph Classen
- Principal Investigator Email
- Joseph.Classen@medizin.uni-leipzig.de
- Contact Person Name
- Joseph Classen
- Contact Person Email
- Joseph.Classen@medizin.uni-leipzig.de
- Site Name
- Paracelsus-Kliniken Deutschland GmbH & Co. KGaA
- Department Name
- Zentrum f. Parkinson Syndrome und Bewegungsstörungen
- Principal Investigator Name
- Brit Mollenhauer
- Principal Investigator Email
- brit.mollenhauer@pkd.de
- Contact Person Name
- Brit Mollenhauer
- Contact Person Email
- brit.mollenhauer@pkd.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Zentrum für Neurologie, Abteilung für Neurodegenerative Erkrankungen
- Principal Investigator Name
- Kathrin Brockmann
- Principal Investigator Email
- kathrin.brockmann@uni-tuebingen.de
- Contact Person Name
- Kathrin Brockmann
- Contact Person Email
- kathrin.brockmann@uni-tuebingen.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Georg Bernhard Landwehrmeyer
- Principal Investigator Email
- Bernhard.landwehmeyer@uni-ulm.de
- Contact Person Name
- Georg Bernhard Landwehrmeyer
- Contact Person Email
- Bernhard.landwehmeyer@uni-ulm.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik f. Neurologie, Zentrum f. Bewegungsstörungen und Neuromodulation
- Principal Investigator Name
- Alfons Schnitzler
- Principal Investigator Email
- Alfons.schnitzler@hhu.de
- Contact Person Name
- Alfons Schnitzler
- Contact Person Email
- Alfons.schnitzler@hhu.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Campus Mitte, Klinik für Neurologie
- Principal Investigator Name
- Andrea Kühn
- Principal Investigator Email
- Andrea.kuehn@charite.de
- Contact Person Name
- Andrea Kühn
- Contact Person Email
- Andrea.kuehn@charite.de
Spain
- Earliest CTIS Part Ii Submission Date
- 07-12-2023
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 858
- Number Of Sites
- 9
- Number Of Participants
- 75
Sites
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Neurology
- Principal Investigator Name
- Lydia López Manzanares
- Principal Investigator Email
- lydialopez@hotmail.com
- Contact Person Name
- Lydia López Manzanares
- Contact Person Email
- lydialopez@hotmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Movement Disorders Unit
- Principal Investigator Name
- Jaime Kulisevsky Bojarski
- Principal Investigator Email
- jkulisevsky@santpau.cat
- Contact Person Name
- Jaime Kulisevsky Bojarski
- Contact Person Email
- jkulisevsky@santpau.cat
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Neurology
- Principal Investigator Name
- Julio Dotor García-Soto
- Principal Investigator Email
- juliodotor@gmail.com
- Contact Person Name
- Julio Dotor García-Soto
- Contact Person Email
- juliodotor@gmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Neurology
- Principal Investigator Name
- María Rosario Luquin Piudo
- Principal Investigator Email
- rluquin@unav.es
- Contact Person Name
- María Rosario Luquin Piudo
- Contact Person Email
- rluquin@unav.es
- Site Name
- Hospital Universitario Fundacion Alcorcon
- Department Name
- Neurology
- Principal Investigator Name
- Lydia Vela Desojo
- Principal Investigator Email
- lvela@fhalcorcon.es
- Contact Person Name
- Lydia Vela Desojo
- Contact Person Email
- lvela@fhalcorcon.es
- Site Name
- Hospital Universitari General De Catalunya
- Department Name
- Neurology
- Principal Investigator Name
- Ernest Balaguer Martínez
- Principal Investigator Email
- a.balaguer@udic.es
- Contact Person Name
- Ernest Balaguer Martínez
- Contact Person Email
- a.balaguer@udic.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Movement Disorder Unit
- Principal Investigator Name
- Francesc Valldeoriola Serra
- Principal Investigator Email
- fvallde@clinic.cat
- Contact Person Name
- Francesc Valldeoriola Serra
- Contact Person Email
- fvallde@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Principal Investigator Name
- Jorge Hernández-Vara
- Principal Investigator Email
- jorherna@vhebron.net
- Contact Person Name
- Jorge Hernández-Vara
- Contact Person Email
- jorherna@vhebron.net
- Site Name
- Policlinica Gipuzkoa S.A.
- Department Name
- Neurology
- Principal Investigator Name
- Gurutz Linazasoro Cristobal
- Principal Investigator Email
- Glinazasoro@inbiomed.org
- Contact Person Name
- Gurutz Linazasoro Cristobal
- Contact Person Email
- Glinazasoro@inbiomed.org
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Syneos Health Netherlands B.V.
- Responsibilities
- Global CRO
Third parties
- {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"MRI Imaging","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Scales and training","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Randomization","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Biotel Research LLC","duties_or_roles":"ECG Provider","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"Analytical Laboratory (PK, ADA)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Invicro LLC","duties_or_roles":"DaT-SPECT","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- RO7046015 (prasinezumab / PRX002)
- Active Substance
- PRASINEZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Starting Dose
- 1500 mg (low dose); 4500 mg for body weight ≥ 65 kg (high dose); 3500 mg for body weight < 65 kg (high dose)
- Dose Levels
- 1500 mg; 3500 mg; 4500 mg
- Frequency
- Once every four weeks (Q4W)
- Maximum Dose
- 4500 mg
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