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Not Yet Recruiting NCT07781644

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

Conditions: Parkinson's Disease

Sex: All
Ages: 40 Years – 85 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 474
Sponsor: Hoffmann-La Roche

Location: Ninewells Hospital, Dundee- Scotland Dundee

Summary

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07781644). StuddyBuddy aggregates publicly available trial information.