Actively Recruiting

Phase 3
Age: 50Years - 85Years
All Genders
NCT07174310

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Led by Hoffmann-La Roche · Updated on 2026-05-06

900

Participants Needed

142

Research Sites

292 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

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.

CONDITIONS

Official Title

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Body weight between 40 and 110 kilograms (88 to 242 pounds) and body mass index between 18 and 34 kg/m2
  • Diagnosis of idiopathic Parkinson's disease based on Movement Disorder Society criteria
  • Currently receiving monotherapy treatment
  • An 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
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding, or planning pregnancy during the study or contraception period
  • Medical history of a parkinsonian syndrome other than idiopathic Parkinson's disease
  • Diagnosis of a significant neurologic 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

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Trial Site Locations

Total: 142 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

Parkinson?s Research Centers of America ? Palo Alto

Palo Alto, California, United States, 94301

Actively Recruiting

6

Profound Research LLC at The Neurology Center of Southern California

Pasadena, California, United States, 91105

Actively Recruiting

7

UCSF Weill Institute for Neurosciences

San Francisco, California, United States, 94158

Actively Recruiting

8

Rocky Mountain Movement Disorders

Englewood, Colorado, United States, 80113

Actively Recruiting

9

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States, 06510

Actively Recruiting

10

Georgetown University

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

11

JEM Research LLC

Atlantis, Florida, United States, 33462

Actively Recruiting

12

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States, 33486

Actively Recruiting

13

K2 - Villages

Lady Lake, Florida, United States, 32159

Actively Recruiting

14

K2 Medical Research-Maitland

Maitland, Florida, United States, 32751

Actively Recruiting

15

Charter Research - Winter Park/Orlando

Orlando, Florida, United States, 32803

Actively Recruiting

16

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States, 96817

Actively Recruiting

17

Northwestern University Feinberg School Of Medicine

Chicago, Illinois, United States, 60611

Actively Recruiting

18

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

19

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

20

Quest Research Institute

Farmington Hills, Michigan, United States, 48334

Actively Recruiting

21

Washington Uni School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

22

Cleveland Clinic Lou Ruvo

Las Vegas, Nevada, United States, 89106

Actively Recruiting

23

Renown Health

Reno, Nevada, United States, 89502

Actively Recruiting

24

University of New Mexico

Albuquerque, New Mexico, United States, 87106

Actively Recruiting

25

Dent Neurological Institute

Amherst, New York, United States, 14226

Actively Recruiting

26

Parkinson's Research Centers of America - Long Island

Commack, New York, United States, 11725

Actively Recruiting

27

Weill Cornell Medical College

New York, New York, United States, 10021

Actively Recruiting

28

NeuroCare Center

Canton, Ohio, United States, 44718

Actively Recruiting

29

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

30

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States, 74136

Actively Recruiting

31

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

32

Veracity Neuroscience

Memphis, Tennessee, United States, 38157

Actively Recruiting

33

Texas Neurology PA

Dallas, Texas, United States, 75206

Actively Recruiting

34

Central Texas Neurology Consultants

Round Rock, Texas, United States, 78681

Actively Recruiting

35

University of Virginia Health System

Charlottesville, Virginia, United States, 22903

Actively Recruiting

36

VCU Health North Hospital

Richmond, Virginia, United States, 23298

Actively Recruiting

37

West Virginia University

Morgantown, West Virginia, United States, 26506

Actively Recruiting

38

Southern Neurology

Kogarah, New South Wales, Australia, 2217

Actively Recruiting

39

Westmead Hospital

Westmead, New South Wales, Australia, 2145

Actively Recruiting

40

Monash Health

Clayton, Victoria, Australia, 3168

Actively Recruiting

41

The Alfred Hospital

Prahan, Victoria, Australia, 3181

Actively Recruiting

42

Perron Institute for Neurological and Translational Science

Nedlands, Western Australia, Australia, 6009

Actively Recruiting

43

Medizinische Universität Graz

Graz, Austria, 8036

Actively Recruiting

44

Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck

Innsbruck, Austria, 6020

Actively Recruiting

45

Kepler Universitätsklinikum GmbH - Neuromed Campus

Linz, Austria, 4020

Actively Recruiting

46

Medizinische Universität Wien

Vienna, Austria, 1090

Actively Recruiting

47

Klinik Ottakring

Vienna, Austria, 1160

Actively Recruiting

48

L2 Ip Instituto de Pesquisas Clinicas Ltda ME

Brasília, Federal District, Brazil, 70200-730

Actively Recruiting

49

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil, 81210-310

Actively Recruiting

50

Núcleo de Pesquisa do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil, 90430-001

Actively Recruiting

51

Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*

São José do Rio Preto, São Paulo, Brazil, 15090-000

Actively Recruiting

52

Centro de Pesquisas Clinicas

São Paulo, São Paulo, Brazil, 01228-200

Actively Recruiting

53

Toronto Western Hospital

Toronto, Ontario, Canada, M5T 2S8

Actively Recruiting

54

CHUM

Montreal, Quebec, Canada, H2X 0A9

Actively Recruiting

55

Montreal Neurological Institute and Hospital

Montreal, Quebec, Canada, H3A 2B4

Actively Recruiting

56

Beijing Friendship Hospital Affiliated of Capital University of Medical Science

Beijing, China, 100050

Actively Recruiting

57

Beijing Tian Tan Hospital,Capital Medical University

Beijing, China, 100071

Actively Recruiting

58

Beijing Hospital of Ministry of Health

Beijing, China, 100730

Actively Recruiting

59

The First Hospital of Jilin University

Changchun, China, 130021

Actively Recruiting

60

West China Hospital of Sichuan University

Chengdu, China, 610041

Actively Recruiting

61

The First Affiliated Hospital, Chongqing Medical University

Chongqing, China, 400016

Actively Recruiting

62

Fujian Medical University Union Hospital

Fuzhou, China, 350001

Actively Recruiting

63

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China, 510080

Actively Recruiting

64

Guangdong Provincial People's Hospital

Guangzhou, China, 510115

Actively Recruiting

65

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China, 510120

Actively Recruiting

66

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China, 310009

Actively Recruiting

67

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, China

Actively Recruiting

68

Nanjing Brain Hospital

Nanjing, China, 210029

Actively Recruiting

69

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China, 200025

Actively Recruiting

70

Huashan Hospital, Fudan University

Shanghai, China, 200040

Actively Recruiting

71

The Second Affiliated Hospital of Suzhou University

Suzhou, China, 215025

Actively Recruiting

72

Tianjin Medical University General Hospital

Tianjin, China, 300052

Actively Recruiting

73

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, China, 710061

Actively Recruiting

74

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

Actively Recruiting

75

Aarhus Universitetshospital Skejby

Aarhus N, Denmark, 8200

Actively Recruiting

76

Bispebjerg Hospital;Neurologisk Afdeling

København NV, Denmark, 2400

Actively Recruiting

77

Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, Rhône, France, 69003

Actively Recruiting

78

APHP - Hopital Henri Mondor

Créteil, France, 94010

Actively Recruiting

79

CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, France, 34295

Actively Recruiting

80

Kliniken Beelitz GmbH

Beelitz, Germany, 14547

Actively Recruiting

81

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, Germany, 12203

Actively Recruiting

82

Heinrich-Heine Universitätsklinik Düsseldorf

Düsseldorf, Germany, 40225

Actively Recruiting

83

Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie

Erlangen, Germany, 91054

Actively Recruiting

84

Paracelsus Elena Klinik Kassel

Kassel, Germany, 34128

Actively Recruiting

85

Klinikum rechts der Isar der TU München

Munich, Germany, 81675

Actively Recruiting

86

Universitatsklinikum Munster

Münster, Germany, 48149

Actively Recruiting

87

Universitaettsklinikum Tübingen

Tübingen, Germany, 72076

Actively Recruiting

88

Universitätsklinikum Würzburg, Neurologische Klinik und Poliklinik

Würzburg, Germany, 97080

Actively Recruiting

89

Università degli studi della Campania Luigi Vanvitelli

Naples, Campania, Italy, 80138

Actively Recruiting

90

Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona

Salerno, Campania, Italy, 84131

Actively Recruiting

91

Ospedale Bellaria

Bologna, Emilia-Romagna, Italy, 40139

Actively Recruiting

92

IRCCS San Raffaele;Clinical Trial Center

Rome, Lazio, Italy, 00166

Actively Recruiting

93

Irccs A.O.U.San Martino Ist

Genoa, Liguria, Italy, 16132

Actively Recruiting

94

Azienda Ospedaliera Spedali Civili

Brescia, Lombardy, Italy, 25100

Actively Recruiting

95

Centro Parkinson e Parkinsonismi

Milan, Lombardy, Italy, 20126

Actively Recruiting

96

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy, 20132

Actively Recruiting

97

IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy, 20133

Actively Recruiting

98

A.O. Universitaria Pisana

Pisa, Tuscany, Italy, 56126

Actively Recruiting

99

Instituto Nacional de Neurologia y Neurocirugia

Mexico City, Mexico CITY (federal District), Mexico, 14390

Actively Recruiting

100

Hospital General de Mexico

Mexico City, Mexico CITY (federal District), Mexico, 6726

Actively Recruiting

101

Podlaskie Centrum Psychogeriatrii

Bia?ystok, Poland, 15-756

Actively Recruiting

102

NZOZ Vitamed

Bydgoszcz, Poland, 85-079

Actively Recruiting

103

Szpital Sw. Wojciecha

Gda?sk, Poland, 80-462

Actively Recruiting

104

NEURO-CARE Sp. z o.o. Sp. Komandytowa

Katowice, Poland, 40-749

Actively Recruiting

105

Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

Krakow, Poland, 31-505

Actively Recruiting

106

Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

Lublin, Poland, 20-410

Actively Recruiting

107

Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

Oświęcim, Poland, 32-600

Actively Recruiting

108

Nmedis sp. z o.o.

Rzeszów, Poland, 35-232

Actively Recruiting

109

NeuroProtect

Warsaw, Poland, 01-684

Actively Recruiting

110

Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.

Warsaw, Poland, 03-242

Actively Recruiting

111

Hospital de Braga

Braga, Portugal, 4710-243

Actively Recruiting

112

Hospital da Luz Coimbra

Coimbra, Portugal, 3020-479

Actively Recruiting

113

Hospital Dr. Nélio Mendonça;Serviço de Neurologia

Funchal, Portugal, 9004-514

Actively Recruiting

114

Hospital Pedro Hispano

Matosinhos Municipality, Portugal, 4464-513

Actively Recruiting

115

CNS - Campus Neurológico

Torres Vedras, Portugal, 2560-280

Actively Recruiting

116

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Actively Recruiting

117

Asan Medical Center

Seoul, South Korea, 05505

Actively Recruiting

118

Boramae Medical Center

Seoul, South Korea, 07061

Actively Recruiting

119

Seoul National University Hospital

Seoul, South Korea, 110-744

Actively Recruiting

120

Hospital General Universitario de Elche

Elche, Alicante, Spain, 03203

Actively Recruiting

121

Hospital General De Catalunya

Sant Cugat del Vallès, Barcelona, Spain, 08195

Actively Recruiting

122

Policlinica Guipuzcoa

Donostia / San Sebastian, Guipuzcoa, Spain, 20009

Actively Recruiting

123

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain, 28922

Actively Recruiting

124

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, Spain, 28223

Actively Recruiting

125

Hospital Universitari Vall d Hebron

Barcelona, Spain, 08035

Actively Recruiting

126

Hospital Clinic Barcelona

Barcelona, Spain, 08036

Actively Recruiting

127

Hospital Ruber Juan Bravo

Madrid, Spain, 28006

Actively Recruiting

128

Hospital Universitario de La Princesa

Madrid, Spain, 28006

Actively Recruiting

129

Hospital Univ 12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

130

Hospital Regional Universitario de Malaga ? Hospital General

Málaga, Spain, 29009

Actively Recruiting

131

Changhua Christian Hospital

Changhua County, Taiwan, 500

Actively Recruiting

132

China Medical University Hospital

North Dist., Taiwan, 40447

Actively Recruiting

133

National Cheng Kung University Hospital

Tainan, Taiwan, 704

Actively Recruiting

134

National Taiwan University Hospital

Taipei, Taiwan, 100

Actively Recruiting

135

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Actively Recruiting

136

Ninewells Hospital, Dundee- Scotland

Dundee, United Kingdom, DD2 1SY

Actively Recruiting

137

Royal Devon and Exeter Hospital (Wonford)

Exeter, United Kingdom, EX2 5DW

Actively Recruiting

138

Royal London Hospital

London, United Kingdom, E1 1FR

Actively Recruiting

139

Charing Cross Hospital

London, United Kingdom, W6 8RF

Actively Recruiting

140

Campus for Ageing and Vitality

Newcastle, United Kingdom, NE4 5PL

Actively Recruiting

141

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom, OX3 7LE

Actively Recruiting

142

Plymouth Hospitals NHS Trust - Derriford Hospital

Plymouth,Devon, United Kingdom, PL6 8DH

Actively Recruiting

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Research Team

R

Reference Study ID Number: BN44715 https://forpatients.roche.com/

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease | DecenTrialz