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Study to Test Effects and Safety of RO7568282 in Early Parkinson's Disease

RecruitingPhase 2

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

Who can join

Ages 40 to 85 · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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

About the study

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.

What is being tested

Sponsor: Hoffmann-La Roche · Participants: 474 · Started: Nov 10, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07781644

Locations in the U.S.

FloridaParkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.