Clinical trial • Phase II • Neurology

PRASINEZUMAB for Early Parkinson's disease

Phase II trial of PRASINEZUMAB for Early Parkinson's disease.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Early Parkinson's disease
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
31-05-2024
First CTIS Authorization Date
18-07-2024

Trial design

Randomised, placebo (ro7046015 placebo); formulation: n/a; route not specified in part i data. placebo arm included.-controlled Phase II trial across 68 sites in Austria, Italy, Poland and others.

Randomised
Yes
Comparator
Placebo (RO7046015 Placebo); formulation: N/A; route not specified in Part I data. Placebo arm included.
Target Sample Size
575
Trial Duration For Participant
644

Eligibility

Recruits 575 Vulnerable population selected. 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..

Vulnerable Population
Vulnerable population selected. 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.

Inclusion criteria

  • {"criterion_text":"- Diagnosis of idiopathic Parkinson's disease (PD) based on Movement disorder society (MDS) criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism"}
  • {"criterion_text":"- On symptomatic PD medication with stable doses for at least 3 months prior to baseline"}
  • {"criterion_text":"- A diagnosis of PD for at least 3 months to maximum 3 years at screening"}
  • {"criterion_text":"- Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV score of 0 at screening and prior to randomization"}
  • {"criterion_text":"- Hoehn and Yahr (H&Y) Stage I or II in OFF medication state at screening and prior to randomization"}
  • {"criterion_text":"- Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader"}

Exclusion criteria

  • {"criterion_text":"- Medical history indicating a Parkinsonian syndrome other than idiopathic PD"}
  • {"criterion_text":"- Diagnosis of PD dementia"}
  • {"criterion_text":"- Diagnosis of a significant neurologic disease other than PD"}
  • {"criterion_text":"- Within the last year, unstable or clinically significant cardiovascular disease"}
  • {"criterion_text":"- Uncontrolled hypertension"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Time to confirmed motor progression event","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- 1. Time-to-worsening of patient’s motor function as reported by the patient in MDS-UPDRS Part II and in the presence of a confirmed motor progression event","definition_or_measurement_approach":"Patient-reported MDS-UPDRS Part II in presence of a confirmed motor progression event"}
  • {"endpoint_text":"- 2. Time to meaningful worsening in Patient Global Impression of Change (PGI-C, Overall Disease Subscale)","definition_or_measurement_approach":"Time to meaningful worsening as measured by PGI-C Overall Disease Subscale"}
  • {"endpoint_text":"- 3. Time to meaningful worsening in Clinician Global Impression of Change (CGI-C, Overall Disease Subscale)","definition_or_measurement_approach":"Time to meaningful worsening as measured by CGI-C Overall Disease Subscale"}
  • {"endpoint_text":"- 4. Change in motor function from baseline to Week 76, as measured by the MDS-UPDRS Part III score","definition_or_measurement_approach":"Change from baseline to Week 76 in MDS-UPDRS Part III total score"}
  • {"endpoint_text":"- 5. Change in bradykinesia and rigidity from baseline to Week 76, as measured by the MDS-UPDRS Part III bradykinesia and rigidity subscore","definition_or_measurement_approach":"Change from baseline to Week 76 in MDS-UPDRS Part III bradykinesia and rigidity subscore"}
  • {"endpoint_text":"- 6. Time to onset of motor complications as assessed through MDS-UPDRS Part IV","definition_or_measurement_approach":"Time to onset assessed using MDS-UPDRS Part IV"}
  • {"endpoint_text":"- 7. Nature, Incidence, seriousness and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)","definition_or_measurement_approach":"AE assessment using NCI CTCAE v5.0 for severity"}
  • {"endpoint_text":"- 8. Incidence of adverse events of special interest","definition_or_measurement_approach":"Incidence counts of predefined adverse events of special interest"}
  • {"endpoint_text":"- 9. Incidence of treatment discontinuation due to adverse events","definition_or_measurement_approach":"Incidence of discontinuations attributed to adverse events"}
  • {"endpoint_text":"- 10. Nature, Incidence, seriousness and severity of infusion-related reactions (IRRs)","definition_or_measurement_approach":"Assessment and reporting of infusion-related reactions (IRRs): nature, incidence, seriousness, severity"}
  • {"endpoint_text":"- 11. Change from baseline in vital signs","definition_or_measurement_approach":"Change over time from baseline in recorded vital signs"}
  • {"endpoint_text":"- 12. Incidence of abnormal vital sign measurements","definition_or_measurement_approach":"Incidence counts of abnormal vital sign measurements"}
  • {"endpoint_text":"- 13. Change from baseline in electrocardiogram (ECG) assessments","definition_or_measurement_approach":"Change from baseline in ECG assessment parameters"}
  • {"endpoint_text":"- 14. Incidence of abnormal ECG assessments","definition_or_measurement_approach":"Incidence counts of abnormal ECG findings"}
  • {"endpoint_text":"- 15. Change from baseline in laboratory measurements","definition_or_measurement_approach":"Change from baseline in specified laboratory parameters"}
  • {"endpoint_text":"- 16. Incidence of abnormal laboratory measurements","definition_or_measurement_approach":"Incidence counts of abnormal laboratory results"}
  • {"endpoint_text":"- 17. Incidence of physical and neurologic examination abnormalities","definition_or_measurement_approach":"Incidence counts of abnormalities on physical and neurological examinations"}
  • {"endpoint_text":"- 18. Change from baseline in suicidal ideation, as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)","definition_or_measurement_approach":"Change from baseline measured by C-SSRS"}
  • {"endpoint_text":"- 19. Serum concentration of prasinezumab at specified timepoints","definition_or_measurement_approach":"Serum PK concentration measurements of prasinezumab at protocol-specified timepoints"}
  • {"endpoint_text":"- 20. Prevalence of anti-drug antibodies (ADAs) against prasinezumab at baseline","definition_or_measurement_approach":"Baseline prevalence of anti-drug antibodies measured in serum"}
  • {"endpoint_text":"- 21. Incidence of ADAs against prasinezumab during the study","definition_or_measurement_approach":"Incidence of treatment-emergent anti-drug antibodies measured during study"}

Recruitment

Planned Sample Size
398
Recruitment Window Months
118
Consent Approach
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. Country- and language-specific subject information and informed consent forms (SIS/ICF) are available (documents listed for multiple countries and languages including English, French, German, Spanish, Polish, Italian).

Geography

Total Number Of Sites
68
Total Number Of Participants
398

Austria

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
650
Number Of Sites
3
Number Of Participants
25

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
University clinic for neurology
Principal Investigator Name
Atbin Djamshidian
Principal Investigator Email
lki.ne.parkinson@tirol-kliniken.at
Contact Person Name
Atbin Djamshidian
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Department of Neurology
Principal Investigator Name
Walter Pirker
Principal Investigator Email
korneuroabtsek@gesundheitsverbund.at
Contact Person Name
Walter Pirker
Site Name
Medical University Of Graz
Department Name
Department of Neurology
Principal Investigator Name
Petra Schwingenschuh
Principal Investigator Email
neurologie@uniklinikum.kages.at
Contact Person Name
Petra Schwingenschuh

Italy

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
03-04-2026
Processing Time Days
653
Number Of Sites
15
Number Of Participants
92

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UO di Neurologia
Principal Investigator Name
Annarita Bentivoglio
Principal Investigator Email
annarita.bentivoglio@policlinicogemelli.it
Contact Person Name
Annarita Bentivoglio
Site Name
Azienda Ospedaliera di Padova
Department Name
UOC Clinica Neurologica
Principal Investigator Name
Angelo Antonini
Principal Investigator Email
angelo.antonini@aopd.veneto.it
Contact Person Name
Angelo Antonini
Contact Person Email
angelo.antonini@aopd.veneto.it
Site Name
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Department Name
UOC di Neurologia
Principal Investigator Name
Paolo Barone
Principal Investigator Email
pbarone@unisa.it
Contact Person Name
Paolo Barone
Contact Person Email
pbarone@unisa.it
Site Name
Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC I Neurologia
Principal Investigator Name
Alessandro Tessitore
Principal Investigator Email
alessandro.tessitore@unicampania.it
Contact Person Name
Alessandro Tessitore
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
UOC Clinica Neurologica Metropolitana (NeuroMet)
Principal Investigator Name
Luisa Sambati
Principal Investigator Email
luisa.sambati@isnb.it
Contact Person Name
Luisa Sambati
Contact Person Email
luisa.sambati@isnb.it
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
UOC Clinica Neurologica
Principal Investigator Name
Mario Zappia
Principal Investigator Email
m.zappia@unict.it
Contact Person Name
Mario Zappia
Contact Person Email
m.zappia@unict.it
Site Name
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Department Name
Dipartimento di Neurologia
Principal Investigator Name
Diego Centonze
Principal Investigator Email
centonze@uniroma2.it
Contact Person Name
Diego Centonze
Contact Person Email
centonze@uniroma2.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO di Neurologia
Principal Investigator Name
Roberto Ceravolo
Principal Investigator Email
roberto.ceravolo@unipi.it
Contact Person Name
Roberto Ceravolo
Contact Person Email
roberto.ceravolo@unipi.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
UO Clinica Neurologica
Principal Investigator Name
Dario Arnaldi
Principal Investigator Email
dario.arnaldi@unige.it
Contact Person Name
Dario Arnaldi
Contact Person Email
dario.arnaldi@unige.it
Site Name
Irccs San Raffaele Roma S.r.l.
Department Name
Centro per la cura e la diagnosi del Parkinson
Principal Investigator Name
Fabrizio Stocchi
Principal Investigator Email
fabrizio.stocchi@sanraffaele.it
Contact Person Name
Fabrizio Stocchi
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
UOC Neurologia 1
Principal Investigator Name
Roberto Eleopra
Principal Investigator Email
roberto.eleopra@istituto-besta.it
Contact Person Name
Roberto Eleopra
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Clinica Neurologica
Principal Investigator Name
Nicola Tambasco
Principal Investigator Email
nicola.tambasco@ospedale.perugia.it
Contact Person Name
Nicola Tambasco
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UO di Neurologia
Principal Investigator Name
Massimo Filippi
Principal Investigator Email
filippi.massimo@hsr.it
Contact Person Name
Massimo Filippi
Contact Person Email
filippi.massimo@hsr.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
UO di Neurologia
Principal Investigator Name
Alessandro Padovani
Principal Investigator Email
alessandro.padovani@unibs.it
Contact Person Name
Alessandro Padovani
Contact Person Email
alessandro.padovani@unibs.it
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
SC di Neurologia
Principal Investigator Name
Carlo Colosimo
Principal Investigator Email
c.colosimo@aospterni.it
Contact Person Name
Carlo Colosimo
Contact Person Email
c.colosimo@aospterni.it

Poland

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
03-04-2026
Processing Time Days
653
Number Of Sites
9
Number Of Participants
66

Sites

Site Name
Nmedis Sp. z o.o.
Principal Investigator Name
Iwona Rościszewska-Żukowska
Principal Investigator Email
iwona.rosciszewska@op.pl
Contact Person Name
Iwona Rościszewska-Żukowska
Contact Person Email
iwona.rosciszewska@op.pl
Site Name
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
Principal Investigator Name
Andrzej Bogucki
Principal Investigator Email
andrzej.bogucki@umed.lodz.pl
Contact Person Name
Andrzej Bogucki
Contact Person Email
andrzej.bogucki@umed.lodz.pl
Site Name
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKP
Department Name
Oddział Kliniczny Neurologii i Epileptologii
Principal Investigator Name
Urszula Fiszer
Principal Investigator Email
kl.neurologii@szpital-orlowskiego.pl
Contact Person Name
Urszula Fiszer
Site Name
Indywidualna Praktyka Lekarska Prof. dr hab. n. med. Konrad Rejdak
Principal Investigator Name
Konrad Rejdak
Principal Investigator Email
indywidualnapraktykakr@gmail.com
Contact Person Name
Konrad Rejdak
Site Name
Centrum Medyczne Neuroprotect
Principal Investigator Name
Maciej Czarnecki
Principal Investigator Email
recepcja@neuroprotect.pl
Contact Person Name
Maciej Czarnecki
Contact Person Email
recepcja@neuroprotect.pl
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Oddział Neurologiczny
Principal Investigator Name
Jarosław Sławek
Principal Investigator Email
jaroslawek@gumed.edu.pl
Contact Person Name
Jarosław Sławek
Contact Person Email
jaroslawek@gumed.edu.pl
Site Name
Vitamed Galaj I Cichomski Sp. j.
Principal Investigator Name
Paweł Lisewski
Principal Investigator Email
lisewski.p@gmail.com
Contact Person Name
Paweł Lisewski
Contact Person Email
lisewski.p@gmail.com
Site Name
Mazowiecki Szpital Brodnowski Sp. z o.o.
Department Name
Klinika Neurologii
Principal Investigator Name
Dariusz Koziorowski
Principal Investigator Email
j.kralka@brodnowski.pl
Contact Person Name
Dariusz Koziorowski
Contact Person Email
j.kralka@brodnowski.pl
Site Name
Krakowska Akademia Neurologii Sp. z o.o.
Department Name
Centrum Neurologii Klinicznej
Principal Investigator Name
Monika Rudzińska-Bar
Principal Investigator Email
mrudzinska@afm.edu.pl
Contact Person Name
Monika Rudzińska-Bar
Contact Person Email
mrudzinska@afm.edu.pl

Spain

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
651
Number Of Sites
25
Number Of Participants
137

Sites

Site Name
Hospital Universitario De Burgos
Department Name
Neurologia
Principal Investigator Name
Esther Cubo Delgado
Principal Investigator Email
mcubo@saludcastillayleon.es
Contact Person Name
Esther Cubo Delgado
Contact Person Email
mcubo@saludcastillayleon.es
Site Name
Hospital Universitari General De Catalunya
Department Name
Neurologia
Principal Investigator Name
Ernest Balaguer Martínez
Principal Investigator Email
e.balaguer@udic.es
Contact Person Name
Ernest Balaguer Martínez
Contact Person Email
e.balaguer@udic.es
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Neurologia
Principal Investigator Name
Rafael Arroyo González
Principal Investigator Email
rafaelarroyo09@gmail.com
Contact Person Name
Rafael Arroyo González
Contact Person Email
rafaelarroyo09@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Neurologia
Principal Investigator Name
Francesc Valldeoriola Serra
Principal Investigator Email
fvallde@clinc.cat
Contact Person Name
Francesc Valldeoriola Serra
Contact Person Email
fvallde@clinc.cat
Site Name
Hospital General Universitario De Elche
Department Name
Neurologia
Principal Investigator Name
Eric Freire Álvarez
Principal Investigator Email
dr.freyre@gmail.com
Contact Person Name
Eric Freire Álvarez
Contact Person Email
dr.freyre@gmail.com
Site Name
Clinica Universidad De Navarra
Department Name
Neurologia
Principal Investigator Name
Rosario Luquin Piudo
Principal Investigator Email
rluquin@unav.es
Contact Person Name
Rosario Luquin Piudo
Contact Person Email
rluquin@unav.es
Site Name
Hospital Universitario De La Princesa
Department Name
Neurologia
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 Universitario De Cruces
Department Name
Neurologia
Principal Investigator Name
Juan Carlos Gómez Esteban
Principal Investigator Email
JUANCARLOS.GOMEZESTEBAN@osakidetza.eus
Contact Person Name
Juan Carlos Gómez Esteban
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Neurologia
Principal Investigator Name
Alejandro Torres Moral
Principal Investigator Email
alextorresmoral1995@gmail.com
Contact Person Name
Alejandro Torres Moral
Contact Person Email
alextorresmoral1995@gmail.com
Site Name
Clinica Montecanal S.L.
Department Name
Neurologia
Principal Investigator Name
Antonio Oliveros Cid
Principal Investigator Email
neurologia.oliveros@gmail.com
Contact Person Name
Antonio Oliveros Cid
Contact Person Email
neurologia.oliveros@gmail.com
Site Name
Policlinica Gipuzkoa S.A.
Department Name
Neurologia
Principal Investigator Name
Gurutz Linazasoro Cristobal
Principal Investigator Email
glinazasoro@telefonica.net
Contact Person Name
Gurutz Linazasoro Cristobal
Contact Person Email
glinazasoro@telefonica.net
Site Name
Hospital Universitario Hm Puerta Del Sur
Department Name
Neurologia
Principal Investigator Name
Raúl Martínez Fernández
Principal Investigator Email
rmartinez.hmcinac@hmhospitales.com
Contact Person Name
Raúl Martínez Fernández
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurologia
Principal Investigator Name
Irene Martínez Torres
Principal Investigator Email
martinez_ire@gva.es
Contact Person Name
Irene Martínez Torres
Contact Person Email
martinez_ire@gva.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Neurologia
Principal Investigator Name
Pablo Mir Rivera
Principal Investigator Email
pmir@us.es
Contact Person Name
Pablo Mir Rivera
Contact Person Email
pmir@us.es
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Neurologia
Principal Investigator Name
Lamberto Landete Pascual
Principal Investigator Email
landete.investigacion@gmail.com
Contact Person Name
Lamberto Landete Pascual
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Neurologia
Principal Investigator Name
Francisco Javier Grandas Pérez
Principal Investigator Email
francisco.grandas@salud.madrid.org
Contact Person Name
Francisco Javier Grandas Pérez
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurologia
Principal Investigator Name
Jaime Kulisevsky Bojarsky
Principal Investigator Email
jkulisevsky@santpau.cat
Contact Person Name
Jaime Kulisevsky Bojarsky
Contact Person Email
jkulisevsky@santpau.cat
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Neurologia
Principal Investigator Name
Diego Santos García
Principal Investigator Email
Diego.Santos.Garcia@sergas.es
Contact Person Name
Diego Santos García
Contact Person Email
Diego.Santos.Garcia@sergas.es
Site Name
Hospital Clinico San Carlos
Department Name
Neurologia
Principal Investigator Name
Rocio Garcia-Ramos Garcia
Principal Investigator Email
garciaramosg@yahoo.es
Contact Person Name
Rocio Garcia-Ramos Garcia
Contact Person Email
garciaramosg@yahoo.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurologia
Principal Investigator Name
Jorge Hernández-Vara
Principal Investigator Email
jorge.hernandez@vallhebron.cat
Contact Person Name
Jorge Hernández-Vara
Contact Person Email
jorge.hernandez@vallhebron.cat
Site Name
Hospital Virgen Del Puerto
Department Name
Neurologia
Principal Investigator Name
Michele Dileone
Principal Investigator Email
dileone.michele@gmail.com
Contact Person Name
Michele Dileone
Contact Person Email
dileone.michele@gmail.com
Site Name
Hospital Ruber Juan Bravo
Department Name
Neurologia
Principal Investigator Name
Juan José López Lozano
Principal Investigator Email
jjlopezlozano@gmail.com
Contact Person Name
Juan José López Lozano
Contact Person Email
jjlopezlozano@gmail.com
Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Neurologia
Principal Investigator Name
Lydia Vela Desojo
Principal Investigator Email
lydia.veladesojo@salud.madrid.org
Contact Person Name
Lydia Vela Desojo
Site Name
Hospital Universitario 12 De Octubre
Department Name
Neurologia
Principal Investigator Name
Alvaro Sánchez Ferro
Principal Investigator Email
asferro@salud.madrid.org
Contact Person Name
Alvaro Sánchez Ferro
Contact Person Email
asferro@salud.madrid.org
Site Name
Hospital Universitario Regional De Malaga
Department Name
Neurologia
Principal Investigator Name
Lucía de flores García Trujillo
Principal Investigator Email
floreslucia78@hotmail.com
Contact Person Name
Lucía de flores García Trujillo
Contact Person Email
floreslucia78@hotmail.com

France

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
649
Number Of Sites
15
Number Of Participants
72

Sites

Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Centre d’investigation Clinique
Principal Investigator Name
Jean-Luc HOUETO
Principal Investigator Email
Jean-Luc.HOUETO@chu-limoges.fr
Contact Person Name
Jean-Luc HOUETO
Contact Person Email
Jean-Luc.HOUETO@chu-limoges.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service de Neurologie Centre d’Investigation Clinique INSERM 1402
Principal Investigator Name
Isabelle BENATRU
Principal Investigator Email
Isabelle.BENATRU@chu-poitiers.fr
Contact Person Name
Isabelle BENATRU
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de Pathologie du mouvement et Centre expert Parkinson - Neurologie Pôle Tête-Cou CETD
Principal Investigator Name
Christine Tranchant
Principal Investigator Email
christine.tranchant@chru-strasbourg.fr
Contact Person Name
Christine Tranchant
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Département de Neurologie – CIC Neurosciences
Principal Investigator Name
Jean-Christophe CORVOL
Principal Investigator Email
jean-christophe.corvol@aphp.fr
Contact Person Name
Jean-Christophe CORVOL
Contact Person Email
jean-christophe.corvol@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Centre Investigation Clinique
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
Centre Hospitalier Universitaire De Montpellier
Department Name
m-charif@chu-montpellier.fr
Principal Investigator Name
MAHMOUD CHARIF
Principal Investigator Email
m-charif@chu-montpellier.fr
Contact Person Name
MAHMOUD CHARIF
Contact Person Email
m-charif@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service de neurologie
Principal Investigator Name
Caroline GIORDANA
Principal Investigator Email
giordana.c@chu-nice.fr
Contact Person Name
Caroline GIORDANA
Contact Person Email
giordana.c@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Clinique neurologique
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
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
SERVICE DE NEUROLOGIE - MALADIES NEURO-DÉGÉNÉRATIVES
Principal Investigator Name
Wassilios MEISSNER
Principal Investigator Email
wassilios.meissner@chu-bordeaux.fr
Contact Person Name
Wassilios MEISSNER
Site Name
Hospices Civils De Lyon
Department Name
Service de Neurologie C GH Est - Hôpital Neurologique Pierre Wertheimer
Principal Investigator Name
Stéphane THOBOIS
Principal Investigator Email
stephane.thobois@chu-lyon.fr
Contact Person Name
Stéphane THOBOIS
Contact Person Email
stephane.thobois@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Service de neurologie
Principal Investigator Name
David MALTÊTE
Principal Investigator Email
david.maltete@chu-rouen.fr
Contact Person Name
David MALTÊTE
Contact Person Email
david.maltete@chu-rouen.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
SERVICE DE NEUROLOGIE
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
Service de Neurologie - Pôle Psychiatrie, Neurologie, Rééducation Neurologique et Médicine Légale
Principal Investigator Name
Elena MORO
Principal Investigator Email
emoro@chu-grenoble.fr
Contact Person Name
Elena MORO
Contact Person Email
emoro@chu-grenoble.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Facultés de Médecine et de Pharmacie
Principal Investigator Name
Ana MARQUES
Principal Investigator Email
ar_marques@chu-clermontferrand.fr
Contact Person Name
Ana MARQUES
Site Name
Centre Hospitalier Regional De Marseille
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

Luxembourg

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
663
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Centre Hospitalier De Luxembourg
Department Name
Neurology
Principal Investigator Name
Rejko Krüger
Principal Investigator Email
rejko.krueger@lih.lu
Contact Person Name
Rejko Krüger
Contact Person Email
rejko.krueger@lih.lu

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
Monitoring, ECG Provider
Name
WCG Clinical Inc.
Responsibilities
eCOA provider (incl. rater training & central review)

Third parties

  • {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Monitoring, ECG Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"Medical Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"eCOA provider (incl. rater training & central review)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
RO7046015
Active Substance
PRASINEZUMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Investigational Product Name
RO7046015 Placebo
Modality
Other

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