Prasinezumab for Early Parkinson's Disease

(PASADENA Trial)

Recruiting at 81 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

316 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in participants with early Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhibitors since baseline. The study will consist of three parts: a 52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part 2). Participants who complete Part 2 (including the 12-week treatment-free follow up visit assessing long term safety and efficacy of RO7046015) will be offered participation in Part 3 open-label extension (all-participants-on-RO7046015-treatment) for an additional 520 weeks.

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 prasinezumab safe for humans?

In the PASADENA study, prasinezumab was given to people with early Parkinson's disease for a year, and the study was designed to check its safety and effectiveness. While the study focused on Parkinson's, it provides some information that prasinezumab has been tested in humans for safety. ^{1 2 3 4 5}

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

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. ^{1 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 the potential of Prasinezumab 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 in the provided abstract, the study's design and objectives suggest it aims to address a key unmet need in Parkinson's treatment. ^{1 4 7 9 10}

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

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

I can have a brain MRI without health risks.

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

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

7. 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]

8. 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]

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]