Test of RO7568282 in early Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 2 trial evaluates the safety, tolerability, pharmacokinetics, and potential efficacy of RO7568282 vs placebo in adults with early-stage Parkinson's disease who are on a stable levodopa regimen. Participants will be randomized to receive RO7568282 or placebo and will be monitored for changes in symptoms and safety over a defined period. Eligibility includes age 40–85, idiopathic PD, stable levodopa monotherapy, and a low MDS-UPDRS Part IV score, among other criteria. The study is conducted at sites in Boca Raton, Shanghai, and Dundee, with Hoffmann-La Roche as lead sponsor.

Why it matters

Who can join: the full rules

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

Where it's running

• Parkinson's Disease and Movement Disorders Center of Boca Raton
  Boca Raton, Florida, United States Recruiting
• Huashan Hospital, Fudan University
  Shanghai, China Recruiting
• Ninewells Hospital, Dundee- Scotland
  Dundee, United Kingdom Recruiting
• Royal London Hospital
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: BP46441 https://forpatients.roche.com/ No email attachments.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.