Actively Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Early-Stage Parkinson's Disease
Led by Hoffmann-La Roche · Updated on 2026-06-04
900
Participants Needed
160
Research Sites
104 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
P
Prothena Biosciences Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and how the body processes (pharmacokinetics) prasinezumab compared with a placebo in people with early-stage Parkinson's disease who are already on stable levodopa treatment. This phase III study aims to better understand how prasinezumab affects the progression of motor symptoms in this population. Participants will be randomly assigned to receive either prasinezumab or placebo through intravenous (IV) infusions during a double-blind treatment period. After completing this phase, eligible participants can join an Open Label Extension (OLE) phase where they will receive prasinezumab. The treatments are given as scheduled IV infusions. During the study, participants will undergo regular assessments including evaluations of motor function using the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. Blood samples will be taken to measure drug levels and immune responses. Safety will be closely monitored, including tracking adverse events and infusion reactions. The primary outcome is the time until confirmed motor progression, with follow-up lasting up to at least 104 weeks.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight within 40-110 kilograms (88-242 pounds) and body mass index between 18-34 kg/m2
- Diagnosis of idiopathic Parkinson's disease based on Movement Disorder Society criteria
- Receiving monotherapy treatment for Parkinson's disease
- MDS-UPDRS Part IV score of 0 at screening and before randomization
- Hoehn and Yahr Stage 1 or 2 off medication at screening and before randomization
- Agreement to follow contraception requirements
You will not qualify if you...
- Pregnant or breastfeeding, or planning pregnancy during the study or contraception period
- Medical history of parkinsonian syndrome other than idiopathic Parkinson's disease
- Diagnosis of significant neurological disease other than Parkinson's disease
- Chronic uncontrolled high blood pressure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to at least 104 weeks
Participants receive intravenous infusions of Prasinezumab or placebo according to the study schedule.
Regular infusion visits throughout treatment period
Duration - Up to 70 days after final dose
Participants are monitored for safety and efficacy outcomes up to 70 days after the final study dose.
Visits for safety and efficacy assessments post-treatment
Trial Site Locations
Total: 160 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
3
Neurology Center of North Orange County
Fullerton, California, United States, 92835
Actively Recruiting
4
Keck School of Medicine of USC
Los Angeles, California, United States, 900033
Actively Recruiting
5
UCLA Neurology Outpatient Clinic
Los Angeles, California, United States, 90095
Actively Recruiting
6
Parkinson?s Research Centers of America ? Palo Alto
Palo Alto, California, United States, 94301
Actively Recruiting
7
Profound Research LLC at The Neurology Center of Southern California
Pasadena, California, United States, 91105
Actively Recruiting
8
UCSF Weill Institute for Neurosciences
San Francisco, California, United States, 94158
Actively Recruiting
9
Rocky Mountain Movement Disorders
Englewood, Colorado, United States, 80113
Actively Recruiting
10
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Actively Recruiting
11
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
12
JEM Research LLC
Atlantis, Florida, United States, 33462
Actively Recruiting
13
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
Actively Recruiting
14
K2 - Villages
Lady Lake, Florida, United States, 32159
Actively Recruiting
15
K2 Medical Research-Maitland
Maitland, Florida, United States, 32751
Actively Recruiting
16
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Actively Recruiting
17
Charter Research - Winter Park/Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
18
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States, 96817
Actively Recruiting
19
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
20
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
21
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
22
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
23
Washington Uni School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
24
Cleveland Clinic Lou Ruvo
Las Vegas, Nevada, United States, 89106
Actively Recruiting
25
Renown Health
Reno, Nevada, United States, 89502
Actively Recruiting
26
Hackensack University Medical Center;Department of Neurology, Neuroscience Institute
Paramus, New Jersey, United States, 07652
Actively Recruiting
27
University of New Mexico
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
28
Dent Neurological Institute
Amherst, New York, United States, 14226
Actively Recruiting
29
Parkinson's Research Centers of America - Long Island
Commack, New York, United States, 11725
Actively Recruiting
30
Weill Cornell Medical College
New York, New York, United States, 10021
Actively Recruiting
31
Asheville Neurology
Asheville, North Carolina, United States, 28806
Actively Recruiting
32
NeuroCare Center
Canton, Ohio, United States, 44718
Actively Recruiting
33
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
34
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
35
University Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
36
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
37
Veracity Neuroscience
Memphis, Tennessee, United States, 38157
Actively Recruiting
38
Texas Neurology PA
Dallas, Texas, United States, 75206
Actively Recruiting
39
Central Texas Neurology Consultants
Round Rock, Texas, United States, 78681
Actively Recruiting
40
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Actively Recruiting
41
VCU Health North Hospital
Richmond, Virginia, United States, 23298
Actively Recruiting
42
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
43
Southern Neurology
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
44
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
45
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
46
The Alfred Hospital
Prahan, Victoria, Australia, 3181
Actively Recruiting
47
Perron Institute for Neurological and Translational Science
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
48
Medizinische Universität Graz
Graz, Austria, 8036
Actively Recruiting
49
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
50
Kepler Universitätsklinikum GmbH - Neuromed Campus
Linz, Austria, 4020
Actively Recruiting
51
Medizinische Universität Wien
Vienna, Austria, 1090
Actively Recruiting
52
Klinik Ottakring
Vienna, Austria, 1160
Actively Recruiting
53
L2 Ip Instituto de Pesquisas Clinicas Ltda ME
Brasília, Federal District, Brazil, 70200-730
Actively Recruiting
54
Hospital das Clinicas - UFMG
Belo Horizonte, Minas Gerais, Brazil, 31270-901
Actively Recruiting
55
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil, 81210-310
Actively Recruiting
56
Núcleo de Pesquisa do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
Actively Recruiting
57
Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
58
Centro de Pesquisas Clinicas
São Paulo, São Paulo, Brazil, 01228-200
Actively Recruiting
59
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
60
CHUM
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
61
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada, H3A 2B4
Actively Recruiting
62
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
Beijing, China, 100050
Actively Recruiting
63
Xuanwu Hospital, Capital Medical University
Beijing, China, 100053
Actively Recruiting
64
Beijing Tian Tan Hospital,Capital Medical University
Beijing, China, 100071
Actively Recruiting
65
Beijing Hospital of Ministry of Health
Beijing, China, 100730
Actively Recruiting
66
The First Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
67
West China Hospital of Sichuan University
Chengdu, China, 610041
Actively Recruiting
68
The First Affiliated Hospital, Chongqing Medical University
Chongqing, China, 400016
Actively Recruiting
69
Fujian Medical University Union Hospital
Fuzhou, China, 350001
Actively Recruiting
70
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China, 510080
Actively Recruiting
71
Guangdong Provincial People's Hospital
Guangzhou, China, 510115
Actively Recruiting
72
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510120
Actively Recruiting
73
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China, 310009
Actively Recruiting
74
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Actively Recruiting
75
Nanjing Brain Hospital
Nanjing, China, 210029
Actively Recruiting
76
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China, 200025
Actively Recruiting
77
Huashan Hospital, Fudan University
Shanghai, China, 200040
Actively Recruiting
78
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215004
Actively Recruiting
79
Tianjin Medical University General Hospital
Tianjin, China, 300052
Actively Recruiting
80
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, China, 710061
Actively Recruiting
81
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Actively Recruiting
82
Aarhus Universitetshospital Skejby
Aarhus N, Denmark, 8200
Actively Recruiting
83
Bispebjerg Hospital;Neurologisk Afdeling
København NV, Denmark, 2400
Actively Recruiting
84
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Bron, Rhône, France, 69003
Actively Recruiting
85
APHP - Hopital Henri Mondor
Créteil, France, 94010
Actively Recruiting
86
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, France, 34295
Actively Recruiting
87
CHU de Nice Hopital Pasteur
Nice, France, 06002
Actively Recruiting
88
APHP - Hopital de la Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
89
Kliniken Beelitz GmbH
Beelitz, Germany, 14547
Actively Recruiting
90
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, 12203
Actively Recruiting
91
St. Josef-Hospital, Klinik für Neurologie
Bochum, Germany, 44791
Actively Recruiting
92
Universitätsklinikum "Carl Gustav Carus"
Dresden, Germany, 01307
Actively Recruiting
93
Heinrich-Heine Universitätsklinik Düsseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
94
Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie
Erlangen, Germany, 91054
Actively Recruiting
95
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
96
Medizinische Hochschule Hannover, Klinik für Neurologie
Hanover, Germany, 30625
Actively Recruiting
97
Universitätsklinikum Heidelberg, Neurologische Klinik, Abteilung für Neuroradiologie
Heidelberg, Germany, 69120
Actively Recruiting
98
Paracelsus Elena Klinik Kassel
Kassel, Germany, 34128
Actively Recruiting
99
Klinikum rechts der Isar der TU München
Munich, Germany, 81675
Actively Recruiting
100
Universitatsklinikum Munster
Münster, Germany, 48149
Actively Recruiting
101
Universitaettsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
102
Universitätsklinikum Würzburg, Neurologische Klinik und Poliklinik
Würzburg, Germany, 97080
Actively Recruiting
103
Università degli studi della Campania Luigi Vanvitelli
Naples, Campania, Italy, 80138
Actively Recruiting
104
Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona
Salerno, Campania, Italy, 84131
Actively Recruiting
105
Ospedale Bellaria
Bologna, Emilia-Romagna, Italy, 40139
Actively Recruiting
106
IRCCS San Raffaele;Clinical Trial Center
Rome, Lazio, Italy, 00166
Actively Recruiting
107
Irccs A.O.U.San Martino Ist
Genoa, Liguria, Italy, 16132
Actively Recruiting
108
Azienda Ospedaliera Spedali Civili
Brescia, Lombardy, Italy, 25100
Actively Recruiting
109
Centro Parkinson e Parkinsonismi
Milan, Lombardy, Italy, 20126
Actively Recruiting
110
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
111
IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy, 20133
Actively Recruiting
112
A.O. Universitaria Pisana
Pisa, Tuscany, Italy, 56126
Actively Recruiting
113
Instituto Nacional de Neurologia y Neurocirugia
Mexico City, Mexico CITY (federal District), Mexico, 14390
Actively Recruiting
114
Hospital General de Mexico
Mexico City, Mexico CITY (federal District), Mexico, 6726
Actively Recruiting
115
Podlaskie Centrum Psychogeriatrii
Bia?ystok, Poland, 15-756
Withdrawn
116
NZOZ Vitamed
Bydgoszcz, Poland, 85-079
Actively Recruiting
117
Szpital Sw. Wojciecha
Gda?sk, Poland, 80-462
Actively Recruiting
118
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Katowice, Poland, 40-749
Actively Recruiting
119
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
Krakow, Poland, 31-505
Actively Recruiting
120
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
Lublin, Poland, 20-410
Actively Recruiting
121
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Oświęcim, Poland, 32-600
Actively Recruiting
122
Nmedis sp. z o.o.
Rzeszów, Poland, 35-232
Actively Recruiting
123
NeuroProtect
Warsaw, Poland, 01-684
Actively Recruiting
124
Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.
Warsaw, Poland, 03-242
Actively Recruiting
125
Hospital de Braga
Braga, Portugal, 4710-243
Actively Recruiting
126
Hospital da Luz Coimbra
Coimbra, Portugal, 3020-479
Actively Recruiting
127
Hospital Dr. Nélio Mendonça;Serviço de Neurologia
Funchal, Portugal, 9004-514
Actively Recruiting
128
Hospital da Senhora da Oliveira-Guimarães
Guimarães, Portugal
Actively Recruiting
129
Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
130
Hospital Pedro Hispano
Matosinhos Municipality, Portugal, 4464-513
Actively Recruiting
131
CNS - Campus Neurológico
Torres Vedras, Portugal, 2560-280
Actively Recruiting
132
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
133
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
134
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
135
Boramae Medical Center
Seoul, South Korea, 07061
Actively Recruiting
136
Seoul National University Hospital
Seoul, South Korea, 110-744
Actively Recruiting
137
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Actively Recruiting
138
Hospital General De Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 08195
Actively Recruiting
139
Policlinica Guipuzcoa
Donostia / San Sebastian, Guipuzcoa, Spain, 20009
Actively Recruiting
140
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
Actively Recruiting
141
Hospital Quiron de Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
142
Hospital Universitari Vall d Hebron
Barcelona, Spain, 08035
Actively Recruiting
143
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Actively Recruiting
144
Hospital Ruber Juan Bravo
Madrid, Spain, 28006
Actively Recruiting
145
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Actively Recruiting
146
Hospital Univ 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
147
Hospital Regional Universitario de Malaga ? Hospital General
Málaga, Spain, 29009
Actively Recruiting
148
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
149
Changhua Christian Hospital
Changhua County, Taiwan, 500
Actively Recruiting
150
China Medical University Hospital
North Dist., Taiwan, 40447
Actively Recruiting
151
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
152
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
153
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
154
Ninewells Hospital, Dundee- Scotland
Dundee, United Kingdom, DD2 1SY
Actively Recruiting
155
Royal Devon and Exeter Hospital (Wonford)
Exeter, United Kingdom, EX2 5DW
Actively Recruiting
156
Royal London Hospital
London, United Kingdom, E1 1FR
Actively Recruiting
157
Charing Cross Hospital
London, United Kingdom, W6 8RF
Actively Recruiting
158
Campus for Ageing and Vitality
Newcastle, United Kingdom, NE4 5PL
Actively Recruiting
159
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
160
Plymouth Hospitals NHS Trust - Derriford Hospital
Plymouth,Devon, United Kingdom, PL6 8DH
Actively Recruiting
Research Team
R
Reference Study ID Number: BN44715 https://forpatients.roche.com/
F
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here