A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
NCT ID: NCT07174310
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
900 participants
INTERVENTIONAL
2025-11-24
2031-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Prasinezumab
Participants will receive Prasinezumab as an IV infusion in the double blind treatment period. Upon completion, eligible participants will enter into the Open Label Extension (OLE) phase.
Prasinezumab
Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
Placebo
Participants will receive placebo as an IV Infusion.
Placebo
Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol
Interventions
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Prasinezumab
Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
Placebo
Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Medical history indicating a parkinsonian syndrome other than idiopathic PD
* Diagnosis of a significant neurologic disease other than PD
* Chronic uncontrolled hypertension
50 Years
85 Years
ALL
No
Sponsors
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Prothena Biosciences Limited
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Neurology Center of North Orange County
Fullerton, California, United States
UCSF Weill Institute for Neurosciences
San Francisco, California, United States
Rocky Mountain Movement Disorders
Englewood, Colorado, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
JEM Research LLC
Atlantis, Florida, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
K2 - Villages
Lady Lake, Florida, United States
K2 Medical Research-Maitland
Maitland, Florida, United States
Charter Research - Winter Park/Orlando
Orlando, Florida, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Dent Neurological Institute
Amherst, New York, United States
NeuroCare Center
Canton, Ohio, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
West Virginia University
Morgantown, West Virginia, United States
CHUM
Montreal, Quebec, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
China Medical University Hospital
North Dist., , Taiwan
Ninewells Hospital, Dundee- Scotland
Dundee, , United Kingdom
Royal London Hospital
London, , United Kingdom
Campus for Ageing and Vitality
Newcastle, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Plymouth Hospitals NHS Trust - Derriford Hospital
Plymouth,Devon, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: BN44715 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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2025-522683-32-00
Identifier Type: CTIS
Identifier Source: secondary_id
BN44715
Identifier Type: -
Identifier Source: org_study_id
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