Tests prasinezumab infusions against placebo in early Parkinson's disease
Tests prasinezumab, given into a vein, in adults with early-stage Parkinson's disease.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
Key facts
- Where
- Bologna, Brescia, Cassino, Catania, Genoa, Milan, Naples, Padova, Pisa, Rome, and Salerno, ItalySee the 14 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT07174310, who can take part
Where in Italy
- 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
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?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07174310EU 2025-522683-32-00
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.