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

Not Yet RecruitingPhase 1, Phase 2

Sponsor: Hoffmann-La Roche

Conditions: Parkinson's Disease

Interventions: RO7568282, Placebo

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 overview

Sex: ALL

Age: 40 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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