Tests prasinezumab infusions against placebo in early Parkinson's disease
Tests prasinezumab, given into a vein, in adults with early-stage Parkinson's disease.
Key facts
- Who runs it
- Hoffmann-La Roche
- Where
- Bologna, Brescia, Cassino, Catania, Genoa, Milan, Naples, Padova, Pisa, Rome, and Salerno, ItalySee the 14 sitesAlso in 17 other countries, 182 sites
- Trial code
- Registry title
- A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 900 people, planned
- Started
- 24 Nov 2025
- Expected to end
- 30 Jun 2031
- Type of study
- Interventional, 2 groups
- Treatments tested
- Prasinezumab
- Placebo
- Record updated
- 5 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with early-stage Parkinson's disease who take levodopa alone and have been on a stable dose. It compares prasinezumab given by IV with placebo.
- Age
- 50 to 85 years
- Sex
- All sexes can join.
- Disease stage
- Early-stage idiopathic Parkinson's disease, Hoehn and Yahr Stage 1 or 2 off medication, with an MDS-UPDRS Part IV score of 0.
- Earlier treatment
- Has received monotherapy treatment (stable symptomatic levodopa alone).
Main reasons for not taking part
- Pregnant or breastfeeding, or planning a pregnancy during the study
- A parkinsonian syndrome other than idiopathic Parkinson's disease
- A significant neurologic disease other than Parkinson's disease
- Chronic uncontrolled high blood pressure
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Body weight within 40-110 kilograms (kg) (88-242 pounds [lbs]) and a body mass index within the range 18-34 kg/m2
- 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
Who cannot take part
- Medical history indicating a parkinsonian syndrome other than idiopathic PD
- Diagnosis of a significant neurologic disease other than PD
- Chronic uncontrolled hypertension
- Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 85 years old?
- Has a doctor told you that you have a different condition with similar signs, such as multiple system atrophy or progressive supranuclear palsy?
- Which medicine do you take for Parkinson's disease now?
- Are you pregnant, breastfeeding, or planning a pregnancy?
Where in Italy
Also in 17 other countries, 182 sites
- Azienda Unita Sanitaria Locale Di BolognaBologna, ItalyTaking people
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- Irccs San Raffaele Roma S.r.l.Cassino, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyTaking people
- Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini CtoMilan, ItalyTaking people
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
- Azienda Ospedaliera di PadovaPadova, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Irccs San Raffaele Roma S.r.l.Rome, ItalyTaking people
- Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'AragonaSalerno, ItalyTaking people
About the trial
What the trial wants to find out
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.
The 2 groups in the trial
- PrasinezumabTreatment being tested
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.
- PlaceboTreatment being tested
Participants will receive placebo as an IV Infusion.
Results explained
A paper that names this trial, explained in plain words.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early-Stage Parkinson's Disease
- Plain-language title
- Tests prasinezumab infusions against placebo in early Parkinson's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07174310, who can take part
- Publications
- Record updated
- 5 November 2026