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: 2025-11-10
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
2025-12-31
2031-07-25
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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The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States
Ninewells Hospital, Dundee- Scotland
Dundee, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: BN44715 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. and Canada)
Email: [email protected]
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