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

NCT04777331 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: BN423582020-004997-232023-507132-21-00
• Study Type: interventional
• Target: 586
• Locations: 9 countries
• Sites: 110

Brief Summary

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.

Conditions

Parkinsons Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• DBT Period: Time-to-worsening of Participant's Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event

  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

  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

  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

  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

  From baseline up to Week 76

Study Arms (2)

Prasinezumab

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Participants will receive placebo as an IV infusion Q4W.

Drug: Placebo

Interventions

Prasinezumab DRUG

Prasinezumab will be administered as an IV infusion to participants Q4W.

Prasinezumab

Placebo DRUG

Prasinezumab placebo will be administered to participants.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Prothena Biosciences Limited: collaborator

Study Sites (110)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Neurology Center of North Orange County

Fullerton, California, 92835, United States

Location

UC San Diego

La Jolla, California, 92037, United States

Location

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

CenExel Rocky Mountain Clinical Research, LLC

Englewood, Colorado, 80113, United States

Location

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

JEM Research LLC

Atlantis, Florida, 33462, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

University of South Florida

Tampa, Florida, 33613-4706, United States

Location

Charter Research - Winter Park/Orlando

Winter Park, Florida, 32792, United States

Location

Northwestern University Feinberg School Of Medicine

Chicago, Illinois, 60611, United States

Location

Southern Illinois University, School of Medicine

Springfield, Illinois, 62702, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2759, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Henry Ford Hospital

West Bloomfield, Michigan, 48322, United States

Location

Dent Neurological Institute

Amherst, New York, 14226, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

University Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Texas Neurology PA

Dallas, Texas, 75206, United States

Location

Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Sentara Neurology Specialists

Norfolk, Virginia, 23507, United States

Location

EvergreenHealth Investigational Drug Services

Kirkland, Washington, 98034, United States

Location

Inland Northwest Research

Spokane, Washington, 99202, United States

Location

Medizinische Universität Graz

Graz, 8036, Austria

Location

Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck

Innsbruck, 6020, Austria

Location

Klinik Ottakring

Vienna, 1160, Austria

Location

Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Clinique Neuro Outaouais

Gatineau, Quebec, J8Y 1W2, Canada

Location

Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

Groupe Hospitalier Pellegrin

Bordeaux, 33000, France

Location

Groupement Hospitalier Est - Hôpital Neurologique

Bron, 69677, France

Location

Hopital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

Hôpital Henri Mondor

Créteil, 94000, France

Location

Hôpital Michallon - Centre d'Investigation Clinique

Grenoble, 38043, France

Location

CHU de Limoges - Hôpital Dupuytren

Limoges, 87042, France

Location

hopital de la Timone

Marseille, 13385, France

Location

CHU Gui de Chauliac

Montpellier, 34000, France

Location

CHU de Nice Hopital Pasteur

Nice, 06002, France

Location

Hopital Pitie-Salpetriere APHP

Paris, 75013, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

CHU Rouen Charles Nicolle

Rouen, 76031, France

Location

CHU de Nantes - Hopital Laennec

Saint-Herblain, 44800, France

Location

CHU Strasbourg Hpital Hautepierre

Strasbourg, 67098, France

Location

CIC - Hôpital Purpan

Toulouse, 31059, France

Location

Università degli studi della Campania Luigi Vanvitelli

Naples, Campania, 80138, Italy

Location

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

Salerno, Campania, 84131, Italy

Location

Ospedale Bellaria

Bologna, Emilia-Romagna, 40139, Italy

Location

IRCCS San Raffaele;Clinical Trial Center

Rome, Lazio, 00166, Italy

Location

Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00168, Italy

Location

Irccs A.O.U.San Martino Ist

Genoa, Liguria, 16132, Italy

Location

Azienda Ospedaliera Spedali Civili

Brescia, Lombardy, 25100, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, 20133, Italy

Location

IRCCS Neuromed

Pozzilli (IS), Molise, 86077, Italy

Location

A.O.U. Policlinico "G.Rodolico - San Marco"

Catania, Sicily, 95123, Italy

Location

A.O. Universitaria Pisana

Pisa, Tuscany, 56126, Italy

Location

AO di Perugia - Ospedale S. Maria della Misericordia

Perugia, Umbria, 06156, Italy

Location

Azienda Ospedaliera S. Maria

Terni, Umbria, 05100, Italy

Location

Azienda Ospedaliera di Padova

Padua, Veneto, 35128, Italy

Location

Centre Hospitalier de Luxembourg

Luxembourg, 1210, Luxembourg

Location

NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki

?ód?, 90-640, Poland

Location

NZOZ Vitamed

Bydgoszcz, 85-079, Poland

Location

Szpital Sw. Wojciecha

Gda?sk, 80-462, Poland

Location

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

Krakow, 31-505, Poland

Location

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

Lublin, 20-016, Poland

Location

Nmedis sp. z o.o.

Rzeszów, 35-232, Poland

Location

Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego

Warsaw, 00-416, Poland

Location

Centrum Medyczne NeuroProtect

Warsaw, 01-684, Poland

Location

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

Warsaw, 03-242, Poland

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital General De Catalunya

Sant Cugat del Vallès, Barcelona, 8195, Spain

Location

Policlínica Guipuzkoa

Donosti-San Sebastián, Guipuzcoa, 20014, Spain

Location

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, LA Coruna, 15006, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);

Móstoles, Madrid, 28938, Spain

Location

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Virgen del Puerto

Plasencia, Palencia, 10600, Spain

Location

Hospital de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic Servicio de Neurologia

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario de Burgos. Servicio de Neurología

Burgos, 09006, Spain

Location

Hospital Ruber Juan Bravo

Madrid, 28006, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29010, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Servicio de Neurología Hospital Viamed Montecanal.

Zaragoza, 50012, Spain

Location

Ninewells Hospital, Dundee- Scotland

Dundee, DD2 1SY, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Campus for Ageing and Vitality

Newcastle, NE4 5PL, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom

Location

North West Anglia NHS Foundation Trust

Peterborough, PE3 9GZ, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 2, 2021
• Study Start: May 5, 2021
• Primary Completion: September 11, 2024
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 9, 2026
• Results First Posted: December 2, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (7); US (31); ES (25); PL (9); CA (4); IT (15); LU (1); FR (15); AU (3)