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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinsons Disease
• Intervention / Treatment: Drug: Prasinezumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 586
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medizinische Universität Graz
  • Innsbruck, Austria, 6020
    • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck
  • Vienna, Austria, 1160
    • Klinik Ottakring
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
    • Toronto, Ontario, Canada, M3B 2S7
      • Toronto Memory Program
  • Quebec
    • Gatineau, Quebec, Canada, J8Y 1W2
      • Clinique Neuro Outaouais
    • Montreal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institute and Hospital
• France
  • Bordeaux, France, 33000
    • Groupe Hospitalier Pellegrin
  • Bron, France, 69677
    • Groupement Hospitalier Est - Hôpital Neurologique
  • Clermont-Ferrand, France, 63003
    • Hôpital Gabriel Montpied
  • Créteil, France, 94000
    • Hôpital Henri Mondor
  • Grenoble, France, 38043
    • Hôpital Michallon - Centre d'Investigation Clinique
  • Limoges, France, 87042
    • CHU de Limoges - Hôpital Dupuytren
  • Marseille, France, 13385
    • Hopital de la Timone
  • Montpellier, France, 34000
    • CHU Gui de Chauliac
  • Nice, France, 06002
    • CHU de Nice Hopital Pasteur
  • Paris, France, 75013
    • Hôpital Pitié-Salpêtrière APHP
  • Poitiers, France, 86021
    • CHU Poitiers
  • Rouen, France, 76031
    • CHU Rouen Charles Nicolle
  • Saint-Herblain, France, 44800
    • CHU de Nantes - Hopital Laennec
  • Strasbourg, France, 67098
    • CHU Strasbourg Hpital Hautepierre
  • Toulouse, France, 31059
    • CIC - Hôpital Purpan
• Italy
  • Campania
    • Napoli, Campania, Italy, 80138
      • Università degli studi della Campania Luigi Vanvitelli
    • Salerno, Campania, Italy, 84131
      • Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40139
      • Ospedale Bellaria
  • Lazio
    • Rome, Lazio, Italy, 00166
      • IRCCS San Raffaele;Clinical Trial Center
    • Rome, Lazio, Italy, 00168
      • Policlinico Universitario Agostino Gemelli
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • Irccs A.O.U.San Martino Ist
  • Lombardy
    • Brescia, Lombardy, Italy, 25100
      • Azienda Ospedaliera Spedali Civili
    • Milan, Lombardy, Italy, 20132
      • IRCCS Ospedale San Raffaele
    • Milan, Lombardy, Italy, 20133
      • IRCCS Istituto Neurologico Carlo Besta
  • Molise
    • Pozzilli (IS), Molise, Italy, 86077
      • IRCCS Neuromed
  • Sicily
    • Catania, Sicily, Italy, 95123
      • A.O.U. Policlinico "G.Rodolico - San Marco"
  • Tuscany
    • Pisa, Tuscany, Italy, 56126
      • A.O. Universitaria Pisana
  • Umbria
    • Perugia, Umbria, Italy, 06156
      • AO di Perugia - Ospedale S. Maria della Misericordia
    • Terni, Umbria, Italy, 05100
      • Azienda Ospedaliera S. Maria
  • Veneto
    • Padua, Veneto, Italy, 35128
      • Azienda Ospedaliera di Padova
• Luxembourg
  • Luxembourg, Luxembourg, 1210
    • Centre Hospitalier de Luxembourg
• Poland
  • ?ód?, Poland, 90-640
    • NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
  • Bydgoszcz, Poland, 85-079
    • NZOZ Vitamed
  • Gda?sk, Poland, 80-462
    • Szpital Sw. Wojciecha
  • Krakow, Poland, 31-505
    • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
  • Lublin, Poland, 20-016
    • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
  • Rzeszów, Poland, 35-232
    • Nmedis sp. z o.o.
  • Warsaw, Poland, 01-684
    • Centrum Medyczne Neuroprotect
  • Warsaw, Poland, 00-416
    • Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego
  • Warsaw, Poland, 03-242
    • Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08036
    • Hospital Clinic Servicio de Neurologia
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos. Servicio de Neurología
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos
  • Madrid, Spain, 28006
    • Hospital Ruber Juan Bravo
  • Málaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Seville, Spain, 41013
    • Hospital Virgen del Rocío
  • Valencia, Spain, 46026
    • Hospital Universitari i Politècnic La Fe
  • Valencia, Spain, 46017
    • Hospital Universitario Dr. Peset
  • Zaragoza, Spain, 50012
    • Servicio de Neurología Hospital Viamed Montecanal.
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche
  • Barcelona
    • Sant Cugat del Vallès, Barcelona, Spain, 8195
      • Hospital General de Catalunya
  • Guipuzcoa
    • Donosti-San Sebastián, Guipuzcoa, Spain, 20014
      • Policlínica Guipuzkoa
  • LA Coruna
    • A Coruña, LA Coruna, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña (CHUAC)
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon
    • Móstoles, Madrid, Spain, 28938
      • HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Quiron de Madrid
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra
  • Palencia
    • Plasencia, Palencia, Spain, 10600
      • Hospital Virgen Del Puerto
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • Hospital de Cruces
• United Kingdom
  • Dundee, United Kingdom, DD2 1SY
    • Ninewells Hospital, Dundee- Scotland
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • Newcastle, United Kingdom, NE4 5PL
    • Campus for Ageing and Vitality
  • Oxford, United Kingdom, OX3 7LE
    • Oxford University Hospitals NHS Foundation Trust
  • Peterborough, United Kingdom, PE3 9GZ
    • North West Anglia NHS Foundation Trust
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
  • California
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • La Jolla, California, United States, 92037
      • UC San Diego
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine of USC
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Colorado
    • Englewood, Colorado, United States, 80113
      • CenExel Rocky Mountain Clinical Research, LLC
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Institute for Neurodegenerative Disorders
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research LLC
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Tampa, Florida, United States, 33613-4706
      • University of South Florida
    • Winter Park, Florida, United States, 32792
      • Charter Research - Winter Park/Orlando
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University, School of Medicine
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114-2759
      • Massachusetts General Hospital
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford Hospital
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurological Institute
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • The Movement Disorder Clinic of Oklahoma
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • University Pennsylvania Hospital
  • Texas
    • Dallas, Texas, United States, 75206
      • Texas Neurology PA
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine Medical Center
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consultants
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Neurology Specialists
  • Washington
    • Kirkland, Washington, United States, 98034
      • EvergreenHealth Investigational Drug Services
    • Spokane, Washington, United States, 99202
      • Inland Northwest Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Prasinezumab; Prasinezumab will be administered as an IV infusion to participants Q4W.
Placebo Comparator: Placebo; Participants will receive placebo as an IV infusion Q4W.	Drug: Placebo; Prasinezumab placebo will be administered to participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DBT Period: Time to Confirmed Motor Progression Event Assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	Time to confirmed motor progression event was the first time point of a worsening event defined as either >= 5 points increase in MDS-UPDRS Part III score (assessed in "OFF" medication state) from baseline sustained over 2 consecutive assessments or a change in medication after first occurrence of >= 5 points increase in MDS-UPDRS Part III score from baseline & before follow-up assessment. MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. The total MDS-UPDRS Part III score (ranging from 0 to 132) is calculated by summing these 33 individual ratings, with higher scores indicating severe impairment.	From study start to end of DBT period to at least 76 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DBT Period: Time-to-worsening of Participant's Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event	Time to worsening of the motor function was defined as ≥3 points increase in MDS-UPDRS Part II score from baseline in the presence of a confirmed motor progression event. For the confirmed motor progression event the definition is as per primary endpoint definition. MDS-UPDRS Part II assesses motor experiences of daily living & contained 13 questions answered by participant. For each question a numeric score is assigned between 0-4, 0 = Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Score range: 0 to 52 with higher score=severe impairment.	From study start to end of DBT period to at least 76 weeks
DBT Period: Time to Meaningful Worsening in Participant Global Impression of Change (PGI-C) Overall Disease Subscale	The PGI is a measure commonly used in PD clinical trials to provide a concise assessment of overall health state. The change component (PGI-C) was intended to measure health state changes as reported by the participant on a 7-point scale (1=Very much improved to 7=Very much worse). The meaningfulness of the change was assessed and reported by the participant.	From study start to end of DBT period to at least 76 weeks
DBT Period: Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C) Overall Disease Subscale	The CGI was a measure commonly used in PD clinical trials to provide a concise assessment of overall health state. The change component (CGI-C) was intended to measure health state changes as reported by the clinician on a 7-point scale (1=Very much improved to 7=Very much worse).	From study start to end of DBT period to at least 76 weeks
DBT Period: Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV	MDS-UPDRS Part IV assessed motor complications of symptomatic treatment, dyskinesias, and motor fluctuations. The rater completed this assessment only for participants on L-Dopa treatment.	From study start to end of DBT period to at least 76 weeks
DBT Period: Change in Motor Function From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Score	MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. The total MDS-UPDRS Part III score (ranging from 0 to 132) is calculated by summing these 33 individual ratings, with higher scores indicating severe impairment.	From baseline up to Week 76
DBT Period: Change in Bradykinesia and Rigidity From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia and Rigidity Subscore	MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. For bradykinesia, subscore ranges from 0 to 52, while rigidity subscore ranges from 0 to 20, with higher scores indicating greater impairment. Change in bradykinesia and rigidity was assessed in "OFF" medication state. Adjusted mean is reported here.	From baseline up to Week 76
DBT Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. Number of participants with atleast 1 AE and SAE are reported here.	From study start to end of DBT period to at least 76 weeks
DBT Period: Number of Participants With Adverse Events of Special Interest (AESI)	An AE was any untoward medical occurrence in participant administered a pharmaceutical product & which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable and unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms/disease temporally associated with use of pharmaceutical product, whether/not considered related to product. AESIs included potential drug-induced liver injury that include an elevated alanine transaminase (ALT) & aspartate aminotransferase (AST) in combination with either an elevated bilirubin/clinical jaundice defined by Hy's law and suspected transmission of an infectious agent by study drug.	From study start to end of DBT period to at least 76 weeks
DBT Period: Number of Participants With Treatment Discontinuation Due to AEs	An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.	From study start to end of DBT period to at least 76 weeks
DBT Period: Number of Participants With Infusion Related Reactions (IRRs)	IRRs were defined as any signs and symptoms (AEs) occurring during infusion and/or within 24 hours administration after the end of infusion and were considered related to study treatment by the investigator. Symptoms include flushing, rash, respiratory difficulty, hypotension, tachycardia.	From study start to end of DBT period to at least 76 weeks
DBT Period: Number of Participants With in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)	C-SSRS=assessment tool used to assess lifetime suicidality of participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, and attempts with actual/potential lethality. Categories have binary responses (yes/no) and include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.	From study start to end of DBT period to at least 76 weeks
DBT Period: Maximum Observed Concentration at Steady-state (Cmax,SS)		Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76
DBT Period: Minimum Observed Concentration at Steady-state (Cmin,SS)		Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76
DBT Period: Area Under the Serum Concentration Time Curve Over the Dosing Interval (AUCTau,SS)		Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76
DBT Period: Percentage of Participants With Anti-Drug Antibodies (ADAs) at Baseline and Post-Treatment		From study start to end of DBT period to at least 76 weeks
OLE Period: Number of Participants With AEs and SAEs	An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention.	From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months)
OLE Period: Number of Participants With AESI	An AE was any untoward medical occurrence in participant administered a pharmaceutical product & which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable and unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms/disease temporally associated with use of pharmaceutical product, whether/not considered related to product. AESIs included potential drug-induced liver injury that include an elevated ALT & AST in combination with either an elevated bilirubin/clinical jaundice defined by Hy's law and suspected transmission of an infectious agent by study drug.	From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months)
OLE Period: Number of Participants With IRRs	IRRs were defined as any signs and symptoms (AEs) occurring during infusion and/or within 24 hours administration after the end of infusion and were considered related to study treatment by the investigator. Symptoms include flushing, rash, respiratory difficulty, hypotension, tachycardia.	From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months)
OLE Period: Number of Participants With in Suicidal Ideation, as Measured by the C-SSRS	C-SSRS=assessment tool used to assess lifetime suicidality of participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, and attempts with actual/potential lethality. Categories have binary responses (yes/no) and include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior.	From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Prothena Biosciences Limited
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): September 11, 2024
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: BN42358; 2020-004997-23 (EudraCT Number); 2023-507132-21-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No