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Clinical Trials in the UK / NCT07781644
Starting soon Phase 1/2

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

NCT07781644 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 1/2
Started
2026-09-30
Last updated
2026-10-20

Condition(s) studied

Parkinson's Disease

Investigational drug(s) / intervention(s)

RO7568282 →Placebo

RO7568282: RO7568282 will be administered as per the schedule specified in the protocol.

Placebo: Placebo will be administered as per the schedule specified in the protocol.

Study 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

Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Time to a Confirmed Motor Progression Event From the Randomization Date, as Measured by the MDS-UPDRS Part III Score — Up to at least Week 104

Trial sites (2)

FacilityCityRegionStatus
Ninewells Hospital, Dundee- Scotland Dundee United Kingdom
Royal London Hospital London United Kingdom

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Official registry record

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

View NCT07781644 on ClinicalTrials.gov ↗ ← All trials in the UK