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NCT07174310RecruitingPhase 3

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

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early-Stage Parkinson's Disease

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
900 (estimated)
First submitted
12 Sept 2025
Start date
24 Nov 2025
Primary completion date
30 Jun 2029
Lead sponsor
Hoffmann-La Roche
NCT number
NCT07174310
EU CT number
2025-522683-32-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 900
  • From 24 Nov 2025 to the primary completion date, 30 Jun 2029
  • 196 sites in 18 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Medical history indicating a parkinsonian syndrome other than idiopathic PD
  • Diagnosis of a significant neurologic disease other than PD
  • Chronic uncontrolled hypertension

Other

  • Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required

Who the study is looking for

  • Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2
  • Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
  • Has received monotherapy treatment
  • An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
  • Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization
  • Agreement to adhere to the contraception requirements

Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (196)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Johannes Kepler University Linz
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LinzAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Stadt Wien Wiener Gesundheitsverbund
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ViennaAustriaRecruiting
Monash Health
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ClaytonAustraliaRecruiting
Southern Neurology
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KogarahAustraliaRecruiting
Perron Institute for Neurological and Translational Science
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NedlandsAustraliaRecruiting
Royal Melbourne Hospital
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ParkvilleAustraliaRecruiting
The Alfred Hospital
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PrahanAustraliaRecruiting
Westmead Hospital
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WestmeadAustraliaRecruiting
Princess Alexandra Hospital
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WoolloongabbaAustraliaRecruiting
Hospital das Clinicas - UFMG
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Belo HorizonteBrazilRecruiting
L2 Ip Instituto de Pesquisas Clinicas Ltda ME
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BrasíliaBrazilRecruiting
Instituto de Neurologia de Curitiba
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CuritibaBrazilRecruiting
Núcleo de Pesquisa do Rio Grande do Sul
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Porto AlegreBrazilRecruiting
Faculdade de Medicina de Ribeirão Preto - Universidade de Sao Paulo
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Ribeirão PretoBrazilRecruiting
Santa Casa de Misericordia de Salvador
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SalvadorBrazilRecruiting
Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*
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São José do Rio PretoBrazilRecruiting
Centro de Pesquisas Clinicas
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São PauloBrazilRecruiting
CHUM
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MontrealCanadaRecruiting
Montreal Neurological Institute and Hospital
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MontrealCanadaRecruiting
University Health Network
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TorontoCanadaRecruiting
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
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BeijingChinaRecruiting
Beijing Tian Tan Hospital, Capital Medical University
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BeijingChinaRecruiting
Beijing Hospital of Ministry of Health
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BeijingChinaRecruiting
Xuanwu Hospital, Capital Medical University
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BeijingChinaRecruiting
The First Hospital of Jilin University
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ChangchunChinaRecruiting
West China Hospital of Sichuan University
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ChengduChinaRecruiting
The First Affiliated Hospital, Chongqing Medical University
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ChongqingChinaRecruiting
Fujian Medical University Union Hospital
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FuzhouChinaRecruiting
The First Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaRecruiting
the First Affiliated Hospital of Sun Yat-sen University
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GuangzhouChinaRecruiting
Guangdong Provincial People's Hospital
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GuangzhouChinaRecruiting
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
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HangzhouChinaRecruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
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HangzhouChinaRecruiting
Nanjing Brain Hospital
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NanjingChinaRecruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
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ShanghaiChinaRecruiting
Huashan Hospital, Fudan University
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ShanghaiChinaRecruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaRecruiting
The Second Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
Tianjin Medical University General Hospital
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TianjinChinaRecruiting
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'anChinaRecruiting
The affiliated hospital of xuzhou medical university
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XuzhouChinaRecruiting
Kliniken Beelitz GmbH
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BeelitzGermanyRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Ruhr University
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BochumGermanyRecruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyRecruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyRecruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
Heidelberg University
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HeidelbergGermanyRecruiting
Universitaetsklinikum des Saarlandes AöR
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HomburgGermanyRecruiting
Paracelsus-Kliniken Deutschland GmbH & Co. KGaA
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KasselGermanyRecruiting
Universitaet Muenster
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MuensterGermanyRecruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
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MunichGermanyRecruiting
LMU Klinikum Muenchen AöR
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MunichGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyRecruiting
Aarhus Universitetshospital
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ÅrhusDenmarkRecruiting
Gødstrup Regional Hospital
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HerningDenmarkRecruiting
Bispebjerg og Frederiksberg Hospital
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-DenmarkRecruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Policlinica Gipuzkoa S.A.
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DonostiaSpainRecruiting
Hospital General Universitario de Elche
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ElcheSpainRecruiting
Hospital Universitario de la Princesa
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Ruber Juan Bravo
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MadridSpainRecruiting
Hospital Universitario Regional de Málaga
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MálagaSpainRecruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainRecruiting
Hospital Universitari General de Catalunya
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Sant Cugat del VallèsSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
CHU Besancon
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Besancon CedexFranceNot yet recruiting
Hospices Civils de Lyon
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BronFranceNot yet recruiting
University Hospital Of Clermont-Ferrand
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Clermont Ferrand Cedex 1FranceNot yet recruiting
Assistance Publique Hopitaux De Paris
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Creteil CedexFranceNot yet recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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La TroncheFranceNot yet recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceNot yet recruiting
Centre Hospitalier Et Universitaire De Limoges
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Limoges Cedex 1FranceNot yet recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceNot yet recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceNot yet recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceNot yet recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceNot yet recruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceNot yet recruiting
Ninewells Hospital, Dundee- Scotland
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DundeeUnited KingdomRecruiting
Royal Devon and Exeter Hospital (Wonford)
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ExeterUnited KingdomRecruiting
Charing Cross Hospital
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LondonUnited KingdomRecruiting
Royal London Hospital
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LondonUnited KingdomRecruiting
Campus for Ageing and Vitality
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NewcastleUnited KingdomRecruiting
Oxford University Hospitals NHS Foundation Trust
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OxfordUnited KingdomRecruiting
Plymouth Hospitals NHS Trust - Derriford Hospital
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Plymouth,DevonUnited KingdomRecruiting
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyRecruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyRecruiting
Irccs San Raffaele Roma S.r.l.
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CassinoItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyRecruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
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MilanItalyRecruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyRecruiting
Azienda Ospedaliera di Padova
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PadovaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Irccs San Raffaele Roma S.r.l.
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RomeItalyRecruiting
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
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SalernoItalyRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Boramae Medical Center
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SeoulSouth KoreaRecruiting
Korea University Guro Hospital
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Instituto Nacional de Neurologia y Neurocirugia
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Mexico CityMexicoRecruiting
Hospital General de Mexico
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Mexico CityMexicoRecruiting
Brain Research Center Amsterdam B.V.
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AmsterdamNetherlandsCompleted
Brain Research Center Den Bosch B.V.
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's-HertogenboschNetherlandsCompleted
Brain Research Center Zwolle B.V.
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ZwolleNetherlandsCompleted
Revit Sp. z o.o.
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BialystokPolandRecruiting
Vitamed Galaj i Cichomski sp.j.
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BydgoszczPolandRecruiting
Krakowska Akademia Neurologii Sp. z o.o.
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CracowPolandRecruiting
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandRecruiting
Neuro-Care Sp. z o.o. sp.k.
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KatowicePolandRecruiting
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
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LublinPolandRecruiting
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
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OswiecimPolandRecruiting
Nmedis sp. z o.o.
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RzeszówPolandRecruiting
Centrum Medyczne NeuroProtect
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WarsawPolandRecruiting
Mazowiecki Szpital Brodnowski Sp. z o.o.
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WarsawPolandRecruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalRecruiting
Hospital da Luz Coimbra, S.A.
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CoimbraPortugalRecruiting
Servico de Saude da Regiao Autonoma Da Madeira EPERAM
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FunchalPortugalRecruiting
Unidade Local De Saude Do Alto Ave E.P.E.
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GuimaraesPortugalRecruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalRecruiting
Unidade Local De Saude De Matosinhos E.P.E.
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Senhora Da HoraPortugalRecruiting
CNS Saude Lda.
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Torres VedrasPortugalRecruiting
Changhua Christian Hospital
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Changhua CountyTaiwanRecruiting
China Medical University Hospital
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North Dist.TaiwanRecruiting
National Cheng Kung University Hospital
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TainanTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Taipei Veterans General Hospital
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TaipeiTaiwanRecruiting
Chang Gung Memorial Hospital Linkou
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Taoyuan CityTaiwanRecruiting
University of New Mexico
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AlbuquerqueUnited StatesRecruiting
Dent Neurological Institute
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AmherstUnited StatesRecruiting
Asheville Neurology
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AshevilleUnited StatesRecruiting
Grady Memorial Hospital
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AtlantaUnited StatesRecruiting
JEM Research LLC
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AtlantisUnited StatesRecruiting
University of Alabama at Birmingham
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BirminghamUnited StatesRecruiting
Parkinson's Disease and Movement Disorders Center of Boca Raton
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Boca RatonUnited StatesRecruiting
Massachusetts General Hospital
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BostonUnited StatesRecruiting
University of Vermont Medical Center
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BurlingtonUnited StatesRecruiting
NeuroCare Center
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CantonUnited StatesRecruiting
University of Virginia Health System
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CharlottesvilleUnited StatesRecruiting
Northwestern University Feinberg School of Medicine
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ChicagoUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
Parkinson's Research Centers of America - Long Island
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CommackUnited StatesRecruiting
Texas Neurology, PA
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DallasUnited StatesRecruiting
Duke University Medical Center
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DurhamUnited StatesRecruiting
Rocky Mountain Movement Disorders
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EnglewoodUnited StatesRecruiting
QUEST Research Institute
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Farmington HillsUnited StatesRecruiting
Neurology Center of North Orange County
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FullertonUnited StatesRecruiting
Hawaii Pacific Neuroscience
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HonoluluUnited StatesRecruiting
University of Kansas Medical Center
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Kansas CityUnited StatesRecruiting
K2 - Villages
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Lady LakeUnited StatesRecruiting
UC San Diego
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La JollaUnited StatesRecruiting
Cleveland Clinic Lou Ruvo
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Las VegasUnited StatesRecruiting
UCLA Neurology Outpatient Clinic
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Los AngelesUnited StatesRecruiting
Keck School of Medicine of USC
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Los AngelesUnited StatesRecruiting
K2 Medical Research - Maitland
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MaitlandUnited StatesRecruiting
Veracity Neuroscience
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MemphisUnited StatesRecruiting
Baptist Hospital of Miami
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MiamiUnited StatesRecruiting
West Virginia University
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MorgantownUnited StatesRecruiting
Vanderbilt University Medical Center
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NashvilleUnited StatesRecruiting
Institute for Neurodegenerative Disorders
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New HavenUnited StatesRecruiting
Columbia University Medical Center
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New YorkUnited StatesRecruiting
Weill Cornell Medical College
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New YorkUnited StatesRecruiting
Charter Research - Winter Park/Orlando
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OrlandoUnited StatesRecruiting
Advent Health Orlando
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OrlandoUnited StatesRecruiting
Parkinson?s Research Centers of America ? Palo Alto
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Palo AltoUnited StatesRecruiting
Hackensack University Medical Center;Department of Neurology, Neuroscience Institute
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ParamusUnited StatesRecruiting
Profound Research LLC at The Neurology Center of Southern California
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PasadenaUnited StatesRecruiting
University Pennsylvania Hospital
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PhiladelphiaUnited StatesRecruiting
Barrow Neurological Institute
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PhoenixUnited StatesRecruiting
Allegheny General Hospital
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PittsburghUnited StatesRecruiting
Oregon Health and Science University
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PortlandUnited StatesRecruiting
Renown Health
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RenoUnited StatesRecruiting
VCU Health North Hospital
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RichmondUnited StatesRecruiting
Central Texas Neurology Consultants
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Round RockUnited StatesRecruiting
UCSF Weill Institute for Neurosciences
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San FranciscoUnited StatesRecruiting
Avera Medical Group
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Sioux FallsUnited StatesRecruiting
Stanford Neuroscience Health Center (SNHC)
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StanfordUnited StatesRecruiting
Washington Uni School of Medicine
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St LouisUnited StatesRecruiting
USF Parkinsons Disease and Movement Disorders Center
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TampaUnited StatesRecruiting
The Movement Disorder Clinic of Oklahoma
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TulsaUnited StatesRecruiting
Georgetown University
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Washington D.C.United StatesRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.