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