A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
- Conditions
- Parkinsons Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT04777331
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 586
- Diagnosis of idiopathic PD based on 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
- On symptomatic PD medication, with stable doses for at least 3 months prior to baseline
- A diagnosis of PD for at least 3 months to maximum 3 years at screening
- MDS-UPDRS Part IV score of 0 at screening and prior to randomization
- Hoehn and Yahr (H&Y) Stage I or II in OFF medication state at screening and prior to randomization
- Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader
- No anticipated changes in PD medication from baseline throughout the study duration based on clinical status during screening
- Willingness and ability to use a smartphone application to measure PD-related symptoms for the duration of the study
- Willingness and ability to wear a smartwatch to measure PD-related motor signs
- Medical history indicating a Parkinsonian syndrome other than idiopathic PD
- Diagnosis of PD dementia
- Diagnosis of a significant neurologic disease other than PD
- Within the last year, unstable or clinically significant cardiovascular disease
- Uncontrolled hypertension
- Drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (Nicotine is allowed, Marijuana use is not allowed)
- Clinically significant abnormalities in laboratory test results at the screening visit, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis
- Allergy to any of the components of prasinezumab, a known hypersensitivity, or a previous IRR following administration of any other monoclonal antibody
- Any contraindications to obtaining a brain magnetic resonance imaging (MRI)
- Any contraindications to DaT-SPECT imaging
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prasinezumab Prasinezumab Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W). Participants will enter into the optional Open Label Extension (OLE) once the double-blind treatment period has completed. Placebo Placebo Participants will receive placebo as an IV infusion Q4W.
- Primary Outcome Measures
Name Time Method Time to Confirmed Motor Progression Event From baseline until 28 days after final dose of study treatment OLE: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) From baseline until 70 days after final dose of study treatment OLE: Number of Participants with Adverse Events of Special Interest (AESI) From baseline until 70 days after final dose of study treatment OLE: Number of Participants with Infusion Related Reactions (IRRs) From baseline until 70 days after final dose of study treatment OLE: Change from Baseline in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) From baseline until 70 days after final dose of study treatment
- Secondary Outcome Measures
Name Time Method Time-to-worsening of Participants Motor Function as Reported by the Participant in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and in the Presence of a Confirmed Motor Progression Event From baseline until 28 days after final dose of study treatment Time to Meaningful Worsening in Patient Global Impression of Change (PGI-C, Overall Disease Subscale) From baseline until 28 days after final dose of study treatment Time to Meanaingful Worsening in Clinician Global Impression of Change (CGI-C, Overall Disease Subscale) From baseline until 28 days after final dose of study treatment Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV From baseline until 28 days after final dose of study treatment Change in Motor Function from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Score From baseline to Week 76 Change in Bradykinesia and Rigidity from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia and Rigidity Subscore From baseline to Week 76 Percentage of Participants With AEs and SAEs From baseline until 70 days after final dose of study treatment Number of Participants with AESI From baseline until 70 days after final dose of study treatment Number of Participants with IRRs From baseline until 70 days after final dose of study treatment Change from Baseline in Suicidal Ideation, as Measured by the C-SSRS From baseline until 28 days after final dose of study treatment Serum Concentration of Prasinezumab From weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 and after week 76 every 12 weeks therafter until end of study (approximately 28 days after the final dose) Percentage of Participants with Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline At Baseline Percentage of Participants with ADAs Against Prasinezumab During the Study Up to end of study visit (approximately 76 weeks)
Trial Locations
- Locations (110)
Dent Neurological Institute
🇺🇸Amherst, New York, United States
A.O.U. Policlinico "G.Rodolico - San Marco"
🇮🇹Catania, Sicilia, Italy
A.O. Universitaria Pisana
🇮🇹Pisa, Toscana, Italy
AO di Perugia - Ospedale S. Maria della Misericordia
🇮🇹Perugia, Umbria, Italy
Hopital Pitie-Salpetriere APHP
🇫🇷Paris, France
CHU Poitiers
🇫🇷Poitiers, France
CHU Rouen Charles Nicolle
🇫🇷Rouen cedex, France
CHU de Nantes - Hopital Laennec
🇫🇷St Herblain, France
CIC - Hôpital Purpan
🇫🇷Toulouse, France
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario ClÃnico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Regional Universitario Carlos Haya
🇪🇸Malaga, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Virgen del RocÃo
🇪🇸Sevilla, Spain
Hospital Universitario Dr. Peset
🇪🇸Valencia, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
Servicio de NeurologÃa Hospital Viamed Montecanal.
🇪🇸Zaragoza, Spain
Ninewells Hospital, Dundee- Scotland
🇬🇧Dundee, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
Charing Cross Hospital
🇬🇧London, United Kingdom
Campus for Ageing and Vitality
🇬🇧Newcastle, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
North West Anglia NHS Foundation Trust
🇬🇧Peterborough, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
CHU Gui de Chauliac
🇫🇷Montpellier, France
CHU Strasbourg Hpital Hautepierre
🇫🇷Strasbourg, France
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
UC San Diego
🇺🇸La Jolla, California, United States
Keck School of Medicine of USC
🇺🇸Los Angeles, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
CenExel Rocky Mountain Clinical Research, LLC
🇺🇸Englewood, Colorado, United States
Institute for Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
JEM Research LLC
🇺🇸Atlantis, Florida, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Charter Research - Winter Park/Orlando
🇺🇸Winter Park, Florida, United States
Northwestern University Feinberg School Of Medicine
🇺🇸Chicago, Illinois, United States
Southern Illinois University, School of Medicine
🇺🇸Springfield, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Quest Research Institute
🇺🇸Farmington Hills, Michigan, United States
Henry Ford Hospital
🇺🇸West Bloomfield, Michigan, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
The Movement Disorder Clinic of Oklahoma
🇺🇸Tulsa, Oklahoma, United States
University Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Texas Neurology PA
🇺🇸Dallas, Texas, United States
Baylor College of Medicine Medical Center
🇺🇸Houston, Texas, United States
Central Texas Neurology Consultants
🇺🇸Round Rock, Texas, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Sentara Neurology Specialists
🇺🇸Norfolk, Virginia, United States
EvergreenHealth Investigational Drug Services
🇺🇸Kirkland, Washington, United States
Inland Northwest Research
🇺🇸Spokane, Washington, United States
Medizinische Universität Graz
🇦🇹Graz, Austria
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck
🇦🇹Innsbruck, Austria
Klinik Ottakring
🇦🇹Wien, Austria
Toronto Memory Program
🇨🇦Toronto, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Clinique Neuro Outaouais
🇨🇦Gatineau, Quebec, Canada
Montreal Neurological Institute and Hospital
🇨🇦Montreal, Quebec, Canada
Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, France
Groupement Hospitalier Est - Hôpital Neurologique
🇫🇷Bron cedex, France
Hopital Gabriel Montpied
🇫🇷Clermont-ferrand, France
Hôpital Henri Mondor
🇫🇷Creteil, France
Hôpital Michallon - Centre d'Investigation Clinique
🇫🇷Grenoble, France
CHU de Limoges - Hôpital Dupuytren
🇫🇷Limoges, France
hopital de la Timone
🇫🇷Marseille, France
CHU de Nice Hopital Pasteur
🇫🇷Nice, France
Università degli studi della Campania Luigi Vanvitelli
🇮🇹Napoli, Campania, Italy
Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona
🇮🇹Salerno, Campania, Italy
Ospedale Bellaria
🇮🇹Bologna, Emilia-Romagna, Italy
Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Lazio, Italy
IRCCS San Raffaele;Clinical Trial Center
🇮🇹Rome, Lazio, Italy
Irccs A.O.U.San Martino Ist
🇮🇹Genova, Liguria, Italy
Azienda Ospedaliera Spedali Civili
🇮🇹Brescia, Lombardia, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milano, Lombardia, Italy
IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Lombardia, Italy
IRCCS Neuromed
🇮🇹Pozzilli (IS), Molise, Italy
Azienda Ospedaliera S. Maria
🇮🇹Terni, Umbria, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Veneto, Italy
Centre Hospitalier de Luxembourg
🇱🇺Luxembourg, Luxembourg
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
🇵🇱?ód?, Poland
NZOZ Vitamed
🇵🇱Bydgoszcz, Poland
Szpital Sw. Wojciecha
🇵🇱Gda?sk, Poland
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
🇵🇱Krakow, Poland
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
🇵🇱Lublin, Poland
Nmedis sp. z o.o.
🇵🇱Rzeszów, Poland
Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego
🇵🇱Warszawa, Poland
Centrum Medyczne NeuroProtect
🇵🇱Warszawa, Poland
Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.
🇵🇱Warszawa, Poland
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
Hospital General De Catalunya
🇪🇸Sant Cugat del Valles, Barcelona, Spain
PoliclÃnica Guipuzkoa
🇪🇸Donosti-San Sebastián, Guipuzcoa, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
🇪🇸Coruña, LA Coruna, Spain
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcon, Madrid, Spain
HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);
🇪🇸Móstoles, Madrid, Spain
Hospital Quiron de Madrid
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Virgen del Puerto
🇪🇸Plasencia, Palencia, Spain
Hospital de Cruces
🇪🇸Barakaldo, Vizcaya, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clinic Servicio de Neurologia
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario de Burgos. Servicio de NeurologÃa
🇪🇸Burgos, Spain
Hospital Ruber Juan Bravo
🇪🇸Madrid, Spain
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain