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Monoclonal Antibodies

Prasinezumab for Early Parkinson's Disease (PASADENA Trial)

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hoehn and Yahr Stage I or II

Idiopathic PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD untreated or treated with MAO-B inhibitor

Must not have

Any prior treatment with an investigational PD-related vaccine (including active immunization or passive immunotherapy with monoclonal antibodies)

Allergy to any of the components of RO7046015 such as citrate, trehalose and polysorbate (Tween) 20 or a known hypersensitivity or an Infusion-related reaction (IRR) to the administration of any other monoclonal antibody

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline over the duration of the study

Summary

This trial will evaluate whether the drug prasinezumab is effective in treating early Parkinson's Disease, compared to a placebo. The study will last for a total of 52 weeks, and participants will be monitored for long-term safety and efficacy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects aren't specified here but could include typical reactions to monoclonal antibodies such as infusion-related reactions, allergies to components like citrate or polysorbate 20, fatigue, headache, joint pain or digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Parkinson's disease is in the early stages.

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

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My weight is between 99 and 242 pounds.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a serious heart condition.

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

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

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

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I carry specific genes linked to Parkinson's disease.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, pre-dose (0 hours) on weeks 4, 20, 36, 52, 56, 68, 80, and 104; at early termination (up to week 104), and follow-up (12 weeks after last dose up to week 116)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, pre-dose (0 hours) on weeks 4, 20, 36, 52, 56, 68, 80, and 104; at early termination (up to week 104), and follow-up (12 weeks after last dose up to week 116)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, pre-dose (0 hours) on weeks 4, 20, 36, 52, 56, 68, 80, and 104; at early termination (up to week 104), and follow-up (12 weeks after last dose up to week 116) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52

Secondary study objectives

Apparent Volume of Distribution (Vz/F) of RO7046015

Area Under the Serum Concentration-Time Curve (AUC) of RO7046015 Over the Dosing Interval

Change From Baseline in Clinical Global Impression of Improvement (CGI-I) Score

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Trial Design

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.

0 / 13Eligibility criteria met