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

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

Recruiting
40-85 years
All
Phase 2

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Overview

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

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

Study details
    Parkinson's Disease

NCT07781644

Hoffmann-La Roche

14 November 2026

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