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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
- RO7568282 (drug)
- Placebo (drug)
Sponsor: Hoffmann-La Roche · Participants: 474 · Started: Nov 10, 2026
Contact the study team
- Reference Study ID Number: BP46441 https://forpatients.roche.com/ No email attachments. · Phone: 888-662-6728
Official record on ClinicalTrials.gov — NCT07781644
Locations in the U.S.
| Florida | Parkinson'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.