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Clinical Trials in the EU / 2025-524064-37-00
Authorised, not yet recruiting Phase II

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

2025-524064-37-00 · tracked via the Priya Life Science EU tracker
Sponsor type
Pharmaceutical company
Therapeutic area
Nervous System Diseases
Decision date
21/10/2026
Enrollment target
122
Sites
Germany, Netherlands, Ireland, Spain

Condition studied

Parkinson’s Disease (PD)

Investigational medicinal product(s)

Ro7568282 placeboRO7568282

Every trial of RO7568282 across our registers →

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Time to a confirmed motor progression event from the randomization date (assessed in off medication state).

Endpoint detail

Change in motor signs from baseline at week 104, as measured by the MDS-UPDRS Part III score (assessed in off medication state), Time to worsening of participants’ motor function as reported by the participant in the presence of a confirmed motor progression event., The incidence, severity, seriousness, and causal relationship of adverse events (AEs)s, The incidence of abnormal laboratory findings in blood and urine, The incidence of abnormal vital signs and electrocardiogram (ECG) parameters, The change in Columbia-Suicide Severity Rating Scale (C-SSRS) from baseline, Plasma concentrations or pharmacokinetic (PK) parameters of RO7568282 (and its metabolite(s) as appropriate)

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524064-37-00 on CTIS ↗ ← All trials in the EU