A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (PASADENA)

A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants With Early Parkinson's Disease With a 6-Year All-Participants-on-Treatment Extension

This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in participants with early Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhibitors since baseline. The study will consist of three parts: a 52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part 2). Participants who complete Part 2 (including the 12-week treatment-free follow up visit assessing long term safety and efficacy of RO7046015) will be offered participation in Part 3 open-label extension (all-participants-on-RO7046015-treatment) for an additional 260 weeks.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: RO7046015; Drug: RO7046015; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 316
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck; Universitätsklinik für Neuroradiologie
• France
  • Bordeaux, France, 33000
    • Groupe Hospitalier Pellegrin
  • Clermont-ferrand, France, 63003
    • Hopital Gabriel Montpied
  • Creteil, France, 94010
    • Hopital Henri Mondor; Service de Neurologie
  • Grenoble, France, 38043
    • Hôpital Michallon - Centre d'Investigation Clinique; Unité de Pharmacologie Clinique - Inserm
  • Marseille, France, 13385
    • Hôpital de la Timone
  • Nice, France, 06002
    • CHU de Nice Hopital Pasteur
  • Paris, France, 75013
    • Hopital Pitie-Salpetriere APHP
  • Poitiers, France, 86000
    • CHU Poitiers
  • Rouen cedex, France, 76031
    • CHU Rouen Charles Nicolle; Centre Expert Parkinson Hôpitaux de Rouen
  • St Herblain, France, 44800
    • CHU de Nantes - Hopital Laennec
  • Toulouse, France, 31059
    • CIC - Hôpital Purpan
• Germany
  • Berlin, Germany, 10117
    • Klinik fur Neurologie; Campus Mittev
  • Düsseldorf, Germany, 40225
    • Heinrich-Heine Universitätsklinik Düsseldorf
  • Kassel, Germany, 34128
    • Paracelsus Elena Klinik Kassel
  • Kiel, Germany, 24105
    • Neurology UKSH Campus Kiel
  • Leipzig, Germany, 04103
    • Klinik und Poliklinik für Neurologie Universitätsklinikum
  • Marburg, Germany, 35043
    • Philipps Universität Marburg; Klinik für Neurologie
  • München, Germany, 81377
    • DZNE Clinical Trial Unit
  • Tübingen, Germany, 72076
    • Universitaettsklinikum Tübingen
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm; Klinik für Neurologie
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona; Neurologia
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa; Servicio de Neurologia
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Barcelona
    • Sant Cugat del Valles, Barcelona, Spain, 08195
      • Hospital General de Catalunya
  • Guipuzcoa
    • Donostia-san Sebastian, Guipuzcoa, Spain, 20014
      • Policlínica Guipuzcoa; Servicio de Neurología
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Fundacion Hospital de Alcorcon
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Uab Medicine
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurology Clinics; Movement Disorders Program
  • California
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • La Jolla, California, United States, 92037
      • Altman Clinical Translational Research Institute
    • Los Angeles, California, United States, 90033
      • USC Keck Medical Center of USC
    • San Francisco, California, United States, 94115
      • University of California at San Francisco
  • Colorado
    • Englewood, Colorado, United States, 80113
      • CenExel Rocky Mountain Clinical Research, LLC
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Associated Neurologists of Southern CT PC
    • New Haven, Connecticut, United States, 06510
      • Molecular Neurolmaging
  • Florida
    • Aventura, Florida, United States, 33180
      • Aventura Neurologic Associates; Department of Research
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • Orlando, Florida, United States, 32806
      • Compass Research East, LLC
    • Tampa, Florida, United States, 33613
      • USF Parkinsons Disease and Movement Disorders Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 20742
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
    • Grand Rapids, Michigan, United States, 49508
      • Spectrum Health Medical Group
    • Novi, Michigan, United States, 48377-3600
      • Henry Ford Health System
  • New York
    • New York, New York, United States, 10032
      • Columbia University
    • Rochester, New York, United States, 14618
      • University of Rochester Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • The Movement Disorder Clinic of Oklahoma
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science Uni
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States, 37204
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consultants
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center; Investigational Drug Service, Pharmacy Department/Baird 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Idiopathic PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD untreated or treated with MAO-B inhibitor
• Body weight range between: >/=45 kg/ 99 pounds (lbs) and less than or equal to (</=) 110 kg/242 lbs
• Body mass index (BMI) of 18 to 34 kilograms per meter-squared (kg/m^2)
• A diagnosis of PD for 2 years or less at screening
• Hoehn and Yahr Stage I or II
• A screening brain DaT-SPECT consistent with PD (central reading)
• Clinical status does not require dopaminergic PD medication and is not expected to require dopaminergic treatment within 52 weeks from baseline
• If presently being treated for PD, a stable dose of MAO-B inhibitor (rasagiline or selegiline) for at least 90 days prior to baseline and not expected to change within 52 weeks
• For women of childbearing potential: use of highly effective contraceptive methods (that result in a failure rate of <1 percent [%] per year) during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug
• For men with female partners of childbearing potential or pregnant female partners, must use a condom during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The female partners should use a contraception method with a failure rate of <1% per year during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug. Use of contraceptive measures is not required for male participants enrolled in Part 3.

Exclusion Criteria:

• Medical history indicating a Parkinson syndrome other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia
• Known carriers of certain familial PD genes (as specified in study protocol)
• History of PD related freezing episodes or falls
• A diagnosis of a significant CNS disease other than Parkinson's disease; history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child
• Mini Mental State Examination (MMSE) </=25
• Reside in a nursing home or assisted care facility
• History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality
• Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study or interfere with the participant's ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data
• Any significant cardiovascular condition
• Any significant laboratory abnormality
• Lactating women
• Prior treatment with dopaminergic medication (for example, levodopa or a dopaminergic agonist) with no clinical treatment response or a clinical treatment response inconsistent with PD (for example, absence of observable response to a sufficiently high-dose of levodopa [i.e., ≥ 600 mg/day])
• Use of any of the following: catechol-O-methyl transferase (COMT) inhibitors (entacapone, tolcapone), amantadine or anticholinergics, or dopaminergic medication (levodopa and both ergot and non-ergot [pramipexole, ropinirole, rotigotine] dopamine agonists) for more than a total of 60 days or within 60 days of baseline
• Anti-epileptic medication for non-seizure-related treatment which has not remained stable for at least 60 days prior to baseline
• Anti-depressant or anxiolytic use that has not remained stable for at least 90 days prior to baseline. The use of fluoxetine and fluvoxamine is not permitted. For patients treated with a MAO-B inhibitor and an antidepressant (except fluoxetine and fluvoxamine), a 6-month period of stable and tolerated dosing before baseline is required.
• Use of any of the following within 90 days prior to baseline: antipsychotics (including clozapine and olanzapine), metoclopramide, alpha methyldopa, clozapine, olanzapine, flunarizine, amoxapine, amphetamine derivatives, reserpine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, and modafinil
• Participated in an investigational drug, device, surgical , or stem cell study in PD
• Any prior treatment with an investigational PD-related vaccine (including active immunization or passive immunotherapy with monoclonal antibodies).
• Prior participation in any RO7046015 or PRX002 study
• Receipt of any non-PD investigational product or device, or participation in a non-PD drug research study within a period of 30 days (or 5 half-lives of the drug, whichever is longer) before baseline
• Receipt of any monoclonal antibody or an investigational immunomodulator within 180 days (or 5 half-lives, whichever is longer) before baseline
• Immunomodulating drugs within 30 days prior to baseline
• Allergy to any of the components of RO7046015 such as citrate, trehalose and polysorbate (Tween) 20 or a known hypersensitivity or an Infusion-related reaction (IRR) to the administration of any other monoclonal antibody
• Any contraindications to obtaining a brain MRI. Patients with a hypersensitivity to iodine may receive an alternative thyroid blocking agent.
• For participants consenting to provide optional cerebrospinal fluid (CSF) samples by lumbar puncture (LP): LP will only be performed if the participant does not have any contraindication to undergoing an LP
• Donation of blood over 500 milliliters (mL) within three months prior to screening

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: RO7046015 High Dose; Participants will receive RO7046015 at high dose level as intravenous infusion every 4 weeks (Q4W) up to 52 weeks in Part 1.	Drug: RO7046015; RO7046015 will be administered at dose of 4500 milligrams (mg) for participants with body-weight greater than or equal to (>/=) 65 kilograms (kg) or 3500 mg for participants with body-weight less than (<) 65 kg.; Other Names: PRX002; prasinezumab; Drug: RO7046015; RO7046015 will be administered at dose of 1500 mg to all participants in the indicated arm.; Other Names: PRX002; prasinezumab
Experimental: Part 1: RO7046015 Low Dose; Participants will receive RO7046015 at low dose level as intravenous infusion Q4W up to 52 weeks in Part 1.	Drug: RO7046015; RO7046015 will be administered at dose of 4500 milligrams (mg) for participants with body-weight greater than or equal to (>/=) 65 kilograms (kg) or 3500 mg for participants with body-weight less than (<) 65 kg.; Other Names: PRX002; prasinezumab; Drug: RO7046015; RO7046015 will be administered at dose of 1500 mg to all participants in the indicated arm.; Other Names: PRX002; prasinezumab
Placebo Comparator: Part 1: Placebo; Participants will receive placebo as intravenous infusion Q4W up to 52 weeks in Part 1.	Drug: Placebo; RO7046015 placebo will be administered to all participants in the indicated arm.
Experimental: Part 2: RO7046015 High Dose; Part 1 RO7046015 high dose group participants and placebo group participants randomized to high dose level will receive RO7046015 at high dose level as intravenous infusion Q4W for additional 52 weeks in Part 2.	Drug: RO7046015; RO7046015 will be administered at dose of 4500 milligrams (mg) for participants with body-weight greater than or equal to (>/=) 65 kilograms (kg) or 3500 mg for participants with body-weight less than (<) 65 kg.; Other Names: PRX002; prasinezumab; Drug: RO7046015; RO7046015 will be administered at dose of 1500 mg to all participants in the indicated arm.; Other Names: PRX002; prasinezumab
Experimental: Part 2: RO7046015 Low Dose; Part 1 RO7046015 low dose group participants and placebo group participants randomized to low dose level will receive RO7046015 at low dose level as intravenous infusion Q4W for additional 52 weeks in Part 2.	Drug: RO7046015; RO7046015 will be administered at dose of 4500 milligrams (mg) for participants with body-weight greater than or equal to (>/=) 65 kilograms (kg) or 3500 mg for participants with body-weight less than (<) 65 kg.; Other Names: PRX002; prasinezumab; Drug: RO7046015; RO7046015 will be administered at dose of 1500 mg to all participants in the indicated arm.; Other Names: PRX002; prasinezumab
Experimental: Part 3: RO7046015 Low Dose; Part 2 RO7046015 low dose group participants and high dose group participants will receive RO7046015 at low dose level as intravenous infusion Q4W for additional 5 years in Part 3.	Drug: RO7046015; RO7046015 will be administered at dose of 4500 milligrams (mg) for participants with body-weight greater than or equal to (>/=) 65 kilograms (kg) or 3500 mg for participants with body-weight less than (<) 65 kg.; Other Names: PRX002; prasinezumab; Drug: RO7046015; RO7046015 will be administered at dose of 1500 mg to all participants in the indicated arm.; Other Names: PRX002; prasinezumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52	The MDS-UPDRS is a multimodal scale consisting of four parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contains 6 questions and are assessed by the examiner (Range 0-24). Part IB contains 7 questions on non-motor experiences of daily living which was completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of Parkinson's Disease (PD) and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. The MDS-UPDRS Total Score equals the sum of Parts I,II, and III (Range: 0-236). A higher score indicated more severe symptoms of Parkinson's disease.	From baseline to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the MDS-UPDRS Part IA, Part IB, Part I Total, Part II Total, Part III Total and Part III Subscores	The MDS-UPDRS is a multimodal scale consisting of four parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contains 6 questions and are assessed by the examiner (Range 0-24). Part IB contains 7 questions on non-motor experiences of daily living which was completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of Parkinson's Disease (PD) and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. There are 4 subscores in Part III: Bradykinesia, Rigidity, Resting tremors and Axial symptoms. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I,II, and III (Range:0-236). A higher score indicated more severe symptoms of Parkinson's disease.	From baseline to Week 52
Change From Baseline in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Striatal Binding Ratio (SBR) in the Putamen Ipsilateral to the Clinically Most Affected Side	DaT-SPECT (dopamine transporter imaging with single photon emission computed tomography) is a dopamine transporter SPECT imaging that uses a radioactive agent called 123^I-ioflupane to quantify the density of the dopamine transporters in the striatum. Changes from baseline to week 52 in DaT-SPECT striatal binding ratios (SBRs; reference region: occipital cortex) in the putamen ipsilateral to the clinically most affected side were analyzed.	From baseline to Week 52
Change From Baseline in Montreal Cognition Assessment (MoCA) Total Score	The Montreal Cognitive Assessment (MoCA) is a rapid screening that was developed to be more sensitive to participants presenting with mild cognitive complaints. It briefly assesses short term and working memory, visuospatial abilities, executive function, attention, concentration, language and orientation. Scores on the MoCA test range from 0-30. Higher scores are associated with better cognitive function.	From baseline to Week 52
Change From Baseline in Clinical Global Impression of Improvement (CGI-I) Score	The CGI-I was intended as a measure of change in health status. CGI-I scores ranged from 1 (very much improved) through to 7 (very much worse). For the CGI-I, participants were divided into one of two groups, Responders or Progressors. Responders were scored on a scale of 1-4 which was rated as "no change", "minimally improved", "much improved" or "very much improved." Progressors were scored on a scale of 5-7 which was rated as "minimally worse", "much worse" or "very much worse." The percentage of participants rated by CGI-I Scale grouping at week 52 was analyzed using a logistic regression model.	From baseline to Week 52
Change From Baseline in Patient Global Impression of Change (PGIC) Score	The PGIC was intended as a measure of change in health state from the participants perspective. PGIC scores ranged from 1 (very much improved) through to 7 (very much worse). For the PGIC, participants were divided into one of two groups, Responders or Progressors. Responders were scored on a scale of 1-4 which was rated as "no change", "minimally improved", "much improved" or "very much improved." Progressors were scored on a scale of 5-7 which was rated as "minimally worse", "much worse" or "very much worse." The percentage of participants rated by PGIC Scale grouping at week 52 was analyzed using a logistic regression model.	From baseline to Week 52
Change From Baseline in Schwab and England Activity of Daily Living (SE-ADL) Score	The SE-ADL is a single item scale assessing Activities of Daily Living on a scale ranging from 0% (bedridden) to 100% (completely independent), using 10% intervals.	From baseline to Week 52
Time to Worsening in Motor or Non-Motor Symptoms	This outcome measure is defined as the time to between first dose of study medication and the date when the particiapnt increases in MDS-UPDRS Part I (Range 0-52) of 3 or more points, or in MDS-UPDRS Part II (Range 0-52) of 3 or more points, whichever comes first. A higher score indicated more severe motor signs of Parkinson's disease.	From baseline to Week 52
Time to Start of Dopaminergic Parkinson's Disease Treatment	This endpoint is defined as the time between first dose of study medication and the date when the participant starts dopaminergic treatment.	From baseline to Week 52
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was any AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	From baseline to Week 52
Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7046015	Samples of the participant's blood was taken to evaluate anti-drug antibodies (ADA). The number of ADA positive participants, Treatment-induced and Treatment-enhanced was reported. Treatment-induced = participants with ADA negative or missing data at baseline but develop an ADA response following exposure to the study drug. Treatment-enhanced = participants with ADA positive at baseline and the titre of one or more post-baseline samples is at least >=4 fold increase greater than the baseline titre sample.	Baseline, Pre-dose (0 hours) on Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116)
Systemic Clearance (CL) of RO7046015	Clearance is a measure of the rate at which a drug is removed from the body.	Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Baseline, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116)
Apparent Volume of Distribution (Vz/F) of RO7046015	Volume of distribution is defined as the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.	Predose (0 hours) and end of infusion (infusion length=2 hours or less) on Baseline, Weeks 4, 20, 36, 52, 56, 68, 80, and 104; at Day 7, Day 14, early termination (up to Week 104), and follow-up (12 weeks after last dose up to Week 116)
Area Under the Serum Concentration-Time Curve (AUC) of RO7046015 Over the Dosing Interval	AUC is defined as the measure of RO7046015 plasma concentration over time.	Baseline over the duration of the study
Maximum Observed Serum Concentration (Cmax) of RO7046015 at Steady-state	Cmax is the maximum observed plasma concentration of RO7046015.	Baseline over the duration of the study
Minimum Observed Serum Concentration (Ctrough) of RO7046015 at Steady-state	Cmin is the minimum observed plasma concentration of RO7046015.	Baseline over the duration of the study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Prothena Biosciences Limited

Publications and helpful links

General Publications

• Pagano G, Taylor KI, Anzures-Cabrera J, Marchesi M, Simuni T, Marek K, Postuma RB, Pavese N, Stocchi F, Azulay JP, Mollenhauer B, Lopez-Manzanares L, Russell DS, Boyd JT, Nicholas AP, Luquin MR, Hauser RA, Gasser T, Poewe W, Ricci B, Boulay A, Vogt A, Boess FG, Dukart J, D'Urso G, Finch R, Zanigni S, Monnet A, Pross N, Hahn A, Svoboda H, Britschgi M, Lipsmeier F, Volkova-Volkmar E, Lindemann M, Dziadek S, Holiga S, Rukina D, Kustermann T, Kerchner GA, Fontoura P, Umbricht D, Doody R, Nikolcheva T, Bonni A; PASADENA Investigators; Prasinezumab Study Group. Trial of Prasinezumab in Early-Stage Parkinson's Disease. N Engl J Med. 2022 Aug 4;387(5):421-432. doi: 10.1056/NEJMoa2202867.
• Lipsmeier F, Taylor KI, Postuma RB, Volkova-Volkmar E, Kilchenmann T, Mollenhauer B, Bamdadian A, Popp WL, Cheng WY, Zhang YP, Wolf D, Schjodt-Eriksen J, Boulay A, Svoboda H, Zago W, Pagano G, Lindemann M. Reliability and validity of the Roche PD Mobile Application for remote monitoring of early Parkinson's disease. Sci Rep. 2022 Jul 15;12(1):12081. doi: 10.1038/s41598-022-15874-4.
• Pagano G, Boess FG, Taylor KI, Ricci B, Mollenhauer B, Poewe W, Boulay A, Anzures-Cabrera J, Vogt A, Marchesi M, Post A, Nikolcheva T, Kinney GG, Zago WM, Ness DK, Svoboda H, Britschgi M, Ostrowitzki S, Simuni T, Marek K, Koller M, Sevigny J, Doody R, Fontoura P, Umbricht D, Bonni A; PASADENA Investigators; Prasinezumab Study Group. A Phase II Study to Evaluate the Safety and Efficacy of Prasinezumab in Early Parkinson's Disease (PASADENA): Rationale, Design, and Baseline Data. Front Neurol. 2021 Oct 1;12:705407. doi: 10.3389/fneur.2021.705407. eCollection 2021.
• Jankovic J, Goodman I, Safirstein B, Marmon TK, Schenk DB, Koller M, Zago W, Ness DK, Griffith SG, Grundman M, Soto J, Ostrowitzki S, Boess FG, Martin-Facklam M, Quinn JF, Isaacson SH, Omidvar O, Ellenbogen A, Kinney GG. Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-alpha-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 1;75(10):1206-1214. doi: 10.1001/jamaneurol.2018.1487.

Helpful Links

• Pasadenastudy.com provides information about the Roche clinical trial NCT03100149 and molecule being investigated in Parkinson's Disease

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): November 27, 2019
• Study Completion (Estimated): September 14, 2026

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: BP39529; 2017-000087-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

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