Prasinezumab for Early Parkinson's Disease

(PASADENA Trial)

Not currently recruiting at 90 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must be taking: MAO-B inhibitors

Must not be taking: Antipsychotics, Antidepressants, Dopaminergics, others

Disqualifiers: Non-idiopathic PD, CNS disease, others

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

Compensation: Varies

Number of Visits: 92

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of prasinezumab, an intravenous medication, for individuals with early Parkinson's Disease (PD). Researchers seek to determine if it can slow the progression of PD symptoms compared to a placebo (a substance with no therapeutic effect) over several years. Initially, participants will receive either a high or low dose of prasinezumab or a placebo; later, all will receive the medication. The trial seeks individuals diagnosed with Parkinson's within the last two years who are not taking medications like levodopa. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to early findings in PD treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you can continue taking MAO-B inhibitors if you have been on a stable dose for at least 90 days. Some medications, like certain antidepressants and antipsychotics, must be stopped or stabilized before joining the trial.

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

Research has shown that prasinezumab has been tested for safety in people with early Parkinson's disease. In these studies, over 900 participants with Parkinson's disease took prasinezumab, and researchers monitored them closely for any safety issues. They found no major safety problems.

Earlier research also demonstrated that prasinezumab can reach the brain and affect α-synuclein, a protein linked to Parkinson's. This indicates that it works in the body as planned without causing significant issues.

While these results are encouraging, it's important to remember that all treatments can have side effects. Some participants reported side effects, but they were generally mild and manageable. Always consult a healthcare provider about potential risks and benefits before joining a trial. ^{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 is believed to play a key role in the progression of Parkinson's disease. Most current treatments for Parkinson's, like levodopa and dopamine agonists, focus on managing symptoms by increasing dopamine levels in the brain. However, Prasinezumab aims to slow down the disease progression itself by interacting directly with alpha-synuclein. Researchers are excited about this approach because it has the potential to modify the disease course rather than just alleviate symptoms, offering hope for a more effective long-term solution for those with early Parkinson's.

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

Research has shown that prasinezumab might slow the progression of movement problems in people with early Parkinson's disease. Studies have found that this treatment reduces levels of α-synuclein, a protein linked to Parkinson's, in the blood. In earlier trials, prasinezumab reached the brain, which is crucial for treating brain-related conditions like Parkinson's. Evidence also suggests that prasinezumab could offer additional benefits when combined with current symptom treatments. These findings provide hope that prasinezumab might effectively manage symptoms of early Parkinson's disease. Participants in this trial will receive either a high dose, a low dose, or a placebo in Part 1, with further dosing adjustments in subsequent parts. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with early Parkinson's Disease (PD) who have been diagnosed within the last 2 years and are at Hoehn and Yahr Stage I or II. They should not need PD medication for at least a year, may be on stable MAO-B inhibitors, must have a BMI of 18-34 kg/m^2, weigh between 45-110 kg, and if of childbearing potential, use effective contraception.

Inclusion Criteria

My Parkinson's disease is in the early stages.

I have Parkinson's with slow movements and either tremor or stiffness, not caused by anything else.

My weight is between 99 and 242 pounds.

Exclusion Criteria

I have never received experimental PD-related vaccines or antibody therapies.

I can have a brain MRI without health risks.

I have used specific Parkinson's disease medications for more than 60 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous prasinezumab or placebo every 4 weeks for 52 weeks

52 weeks

13 visits (in-person, every 4 weeks)

Blinded Dose Extension

All participants receive prasinezumab in a blinded manner every 4 weeks for an additional 52 weeks

52 weeks

13 visits (in-person, every 4 weeks)

Follow-up

Participants are monitored for safety and efficacy after treatment

12 weeks

1 visit (in-person)

Open-label Extension

Participants receive prasinezumab in an open-label manner every 4 weeks for an additional 260 weeks

260 weeks

65 visits (in-person, every 4 weeks)

What Are the Treatments Tested in This Trial?

Interventions

• Prasinezumab

Trial Overview The study tests Prasinezumab (RO7046015/PRX002), an intravenous drug against a placebo in untreated or minimally treated early PD patients over one year. It includes a blinded extension where all participants receive treatment and an open-label phase to assess long-term effects.

How Is the Trial Designed?

Group I: Part 3: RO7046015 Low Dose Experimental Treatment 1 Intervention

All participants who complete Part 1 and Part 2 will receive monthly IV infusions of RO7046015.

Group II: Part 2: RO7046015 Low Dose Experimental Treatment 1 Intervention

Part 1 RO7046015 low dose group participants and placebo group participants randomized to low dose level will receive RO7046015 at low dose level as IV infusion Q4W for additional 52 weeks in Part 2.

Group III: Part 2: RO7046015 High Dose Experimental Treatment 1 Intervention

Part 1 RO7046015 high dose group participants and placebo group participants randomized to high dose level will receive RO7046015 at high dose level as IV infusion Q4W for additional 52 weeks in Part 2.

Group IV: Part 1: RO7046015 Low Dose Experimental Treatment 1 Intervention

Participants will receive RO7046015 at low dose level as IV infusion Q4W up to 52 weeks in Part 1.

Group V: Part 1: RO7046015 High Dose Experimental Treatment 1 Intervention

Participants will receive RO7046015 at high dose level as intravenous (IV) infusion every 4 weeks (Q4W) up to 52 weeks in Part 1.

Group VI: Part 1: Placebo Placebo Group 1 Intervention

Participants will receive placebo as IV infusion Q4W up to 52 weeks in Part 1.

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. 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 ...

2. 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 ...

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

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

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03100149

NCT03100149 | A Study to Evaluate the 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. Front ...

5. 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 ...

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

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