Tests RO7568282 against placebo in early-stage Parkinson's disease
Tests RO7568282 against placebo in adults with early Parkinson's disease.
Plain-language title generated from the registry record
Registry title: Study to Test Effects and Safety of RO7568282 in Early Parkinson's Disease
Key facts
- Where
- Brescia, Cassino, Catania, Milan, Naples, Padova, Pavia, Rome, and Salerno, ItalySee the 12 sites
- Phase
- Phase 2
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 40 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?
- Do you have dementia, or serious problems with memory and thinking?
Source: NCT07781644, who can take part
Where in Italy
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyNot yet recruiting
- Irccs San Raffaele Roma S.r.l.Cassino, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyNot yet recruiting
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyNot yet recruiting
- Ospedale San Raffaele S.r.l.Milan, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyNot yet recruiting
- Azienda Ospedaliera di PadovaPadova, ItalyNot yet recruiting
- Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyNot yet recruiting
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting
- Irccs San Raffaele Roma S.r.l.Rome, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'AragonaSalerno, ItalyNot yet recruiting
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
- NCT07781644EU 2025-524064-37-00
- Record updated
- 9 November 2026
- Original description
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of RO7568282 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 II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants With Early-stage Parkinson's Disease
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of RO7568282 compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.
Inclusion: Must be aged 40 to 85 years inclusive; Diagnosis of idiopathic PD; Has received stable doses of monotherapy treatment with levodopa for at least 2 months prior to baseline; Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV score of 0 at screening and prior to randomization at baseline; Hoehn and Yahr (H\&Y) Stage ≤ 3 (assessed in off medication state) at screening and prior to randomization at baseline; Able to swallow whole capsules.
Exclusion: Medical history indicating a parkinsonian syndrome other than idiopathic PD; Diagnosis of PD dementia; Diagnosis of a significant neurologic disease other than PD; Within the last year, unstable or clinically significant cardiovascular disease; Chronic uncontrolled hypertension; History or presence of brain magnetic resonance imaging (MRI) scan showing evidence of structural abnormalities, other than related to PD; Note: Other protocol-defined inclusion/exclusion criteria also apply.