Prasinezumab for Early Parkinson's Disease

(PADOVA Trial)

Not currently recruiting at 151 trial locations

Overseen By Reference Study ID Number: BN42358 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must be taking: Symptomatic PD medication

Must not be taking: Marijuana

Disqualifiers: PD dementia, Cardiovascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Duration not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests prasinezumab, a new treatment for individuals diagnosed with Parkinson's Disease (PD) within the last three years. The goal is to determine if prasinezumab can improve symptoms when combined with regular PD medications. Participants will receive either the treatment or a placebo through an IV every four weeks. Those who have had Parkinson's for at least three months but not more than three years, and are on stable PD medication, might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the early understanding of prasinezumab's potential.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires that participants are on stable doses of their Parkinson's disease medication for at least 3 months before starting and throughout the study.

Is there any evidence suggesting that prasinezumab is likely to be safe for humans?

Research shows that prasinezumab has been tested for safety in people with early Parkinson's disease. In earlier studies, participants handled the treatment well, indicating that it can reach the brain and work as expected. Notably, higher doses led to greater reductions in a protein called α-synuclein, which is linked to Parkinson's disease.

While these results are encouraging, it's important to remember that studies are still ongoing. Researchers continue to gather more detailed safety information. So far, existing evidence suggests that participants generally tolerate prasinezumab well, with no major safety concerns reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

Prasinezumab is unique because it targets alpha-synuclein, a protein that accumulates in the brains of people with Parkinson's disease, potentially slowing disease progression. Unlike standard treatments like Levodopa, which primarily manage symptoms, Prasinezumab aims to address the underlying cause of the disease. Researchers are excited about this treatment because it offers a new mechanism of action that could change the course of Parkinson's disease, not just alleviate its symptoms.

What evidence suggests that prasinezumab might be an effective treatment for early Parkinson's Disease?

This trial will compare prasinezumab with a placebo in participants with early Parkinson's disease. Studies have shown that prasinezumab may help slow the progression of Parkinson's disease. Research suggests it can lower levels of the protein α-synuclein, which is linked to Parkinson's, in the brain. This reduction could help alleviate movement problems and slow the decline in daily functioning for patients with early-stage Parkinson's. Initial findings indicate that adding prasinezumab to current treatments might provide extra benefits. Overall, the evidence so far is promising for prasinezumab in managing early Parkinson's disease. ^{1 3 6 7 8}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for people with early Parkinson's Disease (PD) who've been diagnosed for 3 months to 3 years, are on stable PD meds, and can use a smartphone app and smartwatch to track symptoms. They should be in the early stages of PD without other neurological diseases or significant health issues like uncontrolled hypertension or recent substance abuse.

Inclusion Criteria

Willingness and ability to wear a smartwatch to measure PD-related motor signs

I have been on stable Parkinson's disease medication for at least 3 months.

My Parkinson's is in the early stages (I or II) without medication.

Exclusion Criteria

I have had serious heart problems in the past year.

My high blood pressure is not under control.

I have been diagnosed with Parkinson's disease dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an IV infusion of prasinezumab or placebo every 4 weeks

Duration not specified

Every 4 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term with prasinezumab

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Prasinezumab

Trial Overview

The study tests Prasinezumab, an IV drug against a placebo in participants with early-stage PD. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug versus placebo. Participants must be on stable PD medication throughout the study.

How Is the Trial Designed?

Group I: Prasinezumab Experimental Treatment 1 Intervention

Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W). Participants will enter into the optional Open Label Extension (OLE) once the double-blind treatment period has completed.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo as an IV infusion Q4W.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Prothena Biosciences Limited

Industry Sponsor

Trials

8

Recruited

1,200+

Published Research Related to This Trial

Pramipexole, in its extended-release formulation, has demonstrated long-term safety and efficacy in treating both early and advanced Parkinson's disease, with treatment durations of up to 113 weeks across multiple studies involving 902 subjects.

Common adverse events included somnolence and dyskinesia, but overall, patients showed sustained improvements in their Parkinson's symptoms as measured by the Unified Parkinson's Disease Rating Scale (UPDRS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and sustained efficacy of extended-release pramipexole in early and advanced Parkinson's disease. Hauser, RA., Schapira, AH., Barone, P., et al.[2022]

A meta-analysis of three randomized controlled trials with 1021 patients found that the once-daily extended-release (ER) formulation of pramipexole has similar adverse event rates compared to the standard immediate-release (IR) formulation in patients with Parkinson's disease.

Common adverse events such as nausea, somnolence, dizziness, and dyskinesia showed no significant differences between the two formulations, indicating that both options are similarly safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of the adverse events associated with extended-release versus standard immediate-release pramipexole in Parkinson disease. Shen, Z., Kong, D.[2022]

Citations

1.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2202867

Trial of Prasinezumab in Early-Stage Parkinson's Disease

In phase 1 trials, prasinezumab showed brain penetration and resulted in dose-dependent reductions from baseline in free serum α-synuclein ...

2.

nature.com

nature.com/articles/s41591-024-03270-6

Sustained effect of prasinezumab on Parkinson's disease ...

Taken together, our results suggest that prasinezumab may slow motor progression and functional decline over the long term in early-stage PD. We ...

3.

roche.com

roche.com/media/releases/med-cor-2025-06-16

Roche to advance prasinezumab into Phase III ...

Multiple endpoints from the PADOVA and OLE studies suggest a potential clinical benefit of prasinezumab when added to effective symptomatic ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39798255/

A Phase 2b, multicenter, randomized, double-blind ...

Introduction: Prasinezumab was shown to potentially delay motor progression in individuals with early-stage Parkinson's disease (PD) who were ...

5.

gene.com

gene.com/media/press-releases/15067/2025-06-15/genentech-to-advance-prasinezumab-into-p

Genentech: Press Releases | Sunday, Jun 15, 2025

Data from the Phase IIb PADOVA study suggest the possible clinical benefit of prasinezumab on top of effective symptomatic treatment in early- ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8518716/

A Phase II Study to Evaluate the Safety and Efficacy of ...

A Phase II study to evaluate the safety and efficacy of Prasinezumab in early Parkinson's disease (PASADENA): rationale, design, and baseline data.

7.

roche.com

roche.com/media/releases/med-cor-2024-12-19

Roche's Phase IIb study of prasinezumab missed primary ...

Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression with a HR=0.84 [0.69-1.01] and p=0.0657, missing ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S1353802024012690

A Phase 2b, multicenter, randomized, double-blind ...

Prasinezumab was shown to potentially delay motor progression in individuals with early-stage Parkinson's disease (PD) who were either treatment-naïve or on ...