Prasinezumab for Early Parkinson's Disease (PASADENA Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Hoffmann-La Roche

Prior Safety Data

Trial Summary

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 260 weeks.

Eligibility Criteria

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.

I was diagnosed with Parkinson's disease 2 years ago or less.

I don't need and am not expected to need Parkinson's medication within the next year.

Exclusion Criteria

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

I am not allergic to citrate, trehalose, polysorbate 20, or any monoclonal antibody.

I have a serious heart condition.

I've taken Parkinson's medication without seeing improvement.

I haven't taken certain medications like antipsychotics or stimulants in the last 90 days.

My Parkinson's is not caused by drugs or other conditions.

I carry specific genes linked to Parkinson's disease.

I have experienced freezing or falls due to Parkinson's disease.

Treatment Details

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.

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 3: RO7046015 Low DoseExperimental Treatment1 Intervention

Part 2 RO7046015 low dose group participants and high dose group participants will receive RO7046015 at low dose level as intravenous infusion Q4W for additional 5 years in Part 3.

Group II: Part 2: RO7046015 Low DoseExperimental Treatment1 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 intravenous infusion Q4W for additional 52 weeks in Part 2.

Group III: Part 2: RO7046015 High DoseExperimental Treatment1 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 intravenous infusion Q4W for additional 52 weeks in Part 2.

Group IV: Part 1: RO7046015 Low DoseExperimental Treatment1 Intervention

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

Group V: Part 1: RO7046015 High DoseExperimental Treatment1 Intervention

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

Group VI: Part 1: PlaceboPlacebo Group1 Intervention

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