Prasinezumab for Early Parkinson's Disease

(PADOVA Trial)

Recruiting at 130 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

586 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing an IV drug called prasinezumab in people with early-stage Parkinson's Disease who are already on stable medication. The drug aims to slow down the disease by attaching to a harmful protein in the brain. Researchers want to see if it works effectively.

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 prasinezumab safe for humans?

The PASADENA study evaluated prasinezumab in people with early Parkinson's disease and found it to be generally safe, as participants received the treatment for up to two years with no major safety concerns reported. ^{1 2 3 4 5}

How is the drug prasinezumab different from other Parkinson's disease treatments?

Prasinezumab is unique because it is a monoclonal antibody that targets and binds to aggregated alpha-synuclein, a protein associated with Parkinson's disease, potentially slowing disease progression, unlike current treatments that do not address this protein. ^{2 4 6 7 8}

What data supports the effectiveness of the drug prasinezumab for early Parkinson's disease?

The PASADENA study is designed to evaluate prasinezumab's potential to slow disease progression in early Parkinson's disease by targeting alpha-synuclein, a protein linked to the disease. While the study's results are not detailed here, the study's design and objectives suggest it aims to address a key unmet need in Parkinson's treatment. ^{2 4 7 9 10}

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. Switzerland pubmed.ncbi.nlm.nih.gov

A Phase II Study to Evaluate the Safety and Efficacy of Prasinezumab in Early Parkinson's Disease (PASADENA): Rationale, Design, and Baseline Data. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Rationale for delayed-start study of pramipexole in Parkinson's disease: the PROUD study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of pramipexole in advanced Parkinson's disease: results of a double-blind, placebo-controlled, parallel-group study. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

Advances in the treatment of Parkinson's disease. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Long-term safety and sustained efficacy of extended-release pramipexole in early and advanced Parkinson's disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Indirect comparisons of adverse events and dropout rates in early Parkinson's disease trials of pramipexole, ropinirole, and rasagiline. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

Do Parkinson's disease patients disclose their adverse events spontaneously? [2021]

9. England pubmed.ncbi.nlm.nih.gov

Pramipexole for the treatment of early Parkinson's disease. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Pramipexole: a nonergot dopamine agonist as drug therapy in Parkinson's disease. [2009]