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 11-Year All-Participants-on-Treatment Extension

Who is this study for? Patients with early Parkinson's disease
What treatments are being studied? RO7046015
Status: Active_not_recruiting
Location: See all (56) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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 520 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Uab Medicine
Birmingham
Arizona
Barrow Neurology Clinics
Phoenix
California
Neurology Center of North Orange County
Fullerton
USC Keck Medical Center of USC
Los Angeles
University of California at San Francisco
San Francisco
Colorado
CenExel Rocky Mountain Clinical Research, LLC
Englewood
Connecticut
Associated Neurologists of Southern CT PC
Fairfield
Molecular Neurolmaging
New Haven
Florida
Aventura Neurologic Associates
Aventura
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton
Compass Research East, LLC
Orlando
USF Parkinsons Disease and Movement Disorders Center
Tampa
Illinois
Northwestern University
Evanston
Kansas
University of Kansas Medical Center
Kansas City
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Michigan
Quest Research Institute
Farmington Hills
Corewell Health Neurology and Epilepsy - Beltline
Grand Rapids
Henry Ford Health System
West Bloomfield
New York
Columbia University
New York
University of Rochester Medical Center
Rochester
Oklahoma
The Movement Disorder Clinic of Oklahoma
Tulsa
Oregon
Oregon Health & Science Uni
Portland
Pennsylvania
UNIVERSITY of PENNSYLVANIA
Philadelphia
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
Baylor College
Houston
Central Texas Neurology Consultants
Round Rock
Vermont
University of Vermont Medical Center
Burlington
Other Locations
Austria
Medizinische Universität Innsbruck
Innsbruck
France
Groupe Hospitalier Pellegrin
Bordeaux
Hopital Gabriel Montpied
Clermont-ferrand
Hopital Henri Mondor
Créteil
Hôpital Michallon - Centre d'Investigation Clinique
Grenoble
hopital de la Timone
Marseille
CHU de Nice Hopital Pasteur
Nice
Hopital Pitie-Salpetriere APHP
Paris
CHU Poitiers
Poitiers
CHU Rouen Charles Nicolle
Rouen
CHU de Nantes - Hopital Laennec
Saint-herblain
CIC - Hôpital Purpan
Toulouse
Germany
Klinik fur Neurologie
Berlin
Heinrich-Heine Universitätsklinik Düsseldorf
Düsseldorf
Paracelsus Elena Klinik Kassel
Kassel
Klinik und Poliklinik für Neurologie Universitätsklinikum
Leipzig
Philipps Universität Marburg
Marburg
DZNE Clinical Trial Unit
München
Universitaettsklinikum Tübingen
Tübingen
Universitätsklinikum Ulm
Ulm
Spain
Fundacion Hospital de Alcorcon
Alcorcón
Hospital Clinic de Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Policlínica Guipuzcoa
Donostia / San Sebastian
Hospital Universitario de la Princesa
Madrid
Clinica Universidad de Navarra
Pamplona/iruña
Hospital General de Catalunya
Sant Cugat Del Vallès
Hospital Universitario Virgen Macarena
Seville
Time Frame
Start Date: 2017-06-27
Completion Date: 2031-12-01
Participants
Target number of participants: 316
Treatments
Experimental: Part 1: RO7046015 High Dose
Participants will receive RO7046015 at high dose level as intravenous (IV) infusion every 4 weeks (Q4W) up to 52 weeks in Part 1.
Experimental: Part 1: RO7046015 Low Dose
Participants will receive RO7046015 at low dose level as IV infusion Q4W up to 52 weeks in Part 1.
Placebo_comparator: Part 1: Placebo
Participants will receive placebo as IV infusion Q4W up to 52 weeks in Part 1.
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 IV infusion Q4W for additional 52 weeks in Part 2.
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 IV infusion Q4W for additional 52 weeks in Part 2.
Experimental: Part 3: RO7046015 Low Dose
All participants who complete Part 1 and Part 2 will receive monthly IV infusions of RO7046015.
Related Therapeutic Areas
Sponsors
Collaborators: Prothena Biosciences Limited
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov