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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline over the duration of the study

Awards & highlights

PASADENA Trial 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.Check my eligibility

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.See study design

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.

PASADENA Trial 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.

PASADENA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

+12 more

PASADENA 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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,738 Total Patients Enrolled

Prothena Biosciences LimitedIndustry Sponsor

7 Previous Clinical Trials

849 Total Patients Enrolled

Media Library

Prasinezumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03100149 — Phase 2

Parkinson's Disease Research Study Groups: Part 1: RO7046015 High Dose, Part 1: RO7046015 Low Dose, Part 1: Placebo, Part 2: RO7046015 High Dose, Part 2: RO7046015 Low Dose, Part 3: RO7046015 Low Dose

Parkinson's Disease Clinical Trial 2023: Prasinezumab Highlights & Side Effects. Trial Name: NCT03100149 — Phase 2

Prasinezumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03100149 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for participants to join this clinical trial at the present time?

"According to clinicaltrials.gov, the recruitment period for this trial concluded as of November 21st 2022. Nonetheless, there are currently 486 other medical studies open to patient enrolment."

Answered by AI

What kind of dangers, if any, are associated with RO7046015?

"Based on the data available, RO7046015 was assigned a score of 2 for safety as it is currently undergoing Phase 2 trials. This indicates that while there are some preliminary results supporting its security, no efficacy has been proven yet."

Answered by AI

How widely has this investigation been distributed geographically?

"Patients are being accepted for the study at Spectrum Health Medical Group in Grand Rapids, Michigan, Compass Research East LLC located in Orlando, Florida, and Quest Research Institute situated in Farmington Hills. Furthermore, there are 33 other enrolment sites across the country."

Answered by AI

Can you provide details on other research projects concerning RO7046015?

"RO7046015 was first explored in 2017 at Altman Clinical Translational Research Institute. A total of 18,325 studies have been completed to date, 2 of which are active. Notably, a substantial number of these trials are being held out Grand Rapids, Michigan."

Answered by AI

Am I eligible to participate in this trial?

"This clinical trial is seeking 316 participants who have been diagnosed with Parkinson's disease (PD) and are between 40 and 80 years old."

Answered by AI

Has there been any prior experimentation with this research endeavor?

"Presently, 82 urban centres and 10 nations are running two concurrent experiments with RO7046015. In 2017, Hoffmann-La Roche initiated the original trial involving 316 participants; it achieved Phase 2 drug approval at that time. Since then 18325 studies have been performed."

Answered by AI

Is this research accessible to participants aged fifty or above?

"This clinical trial has a strict age bracket for eligibility. The lower limit of 40 years old and the upper bound is 80 years old."

Answered by AI

How many individuals have been formally accepted into the trial?

"Unfortunately, at this time this trial is not recruiting new patients. It was first publicized on June 27th 2017 and last updated November 21st 2022. However, there are currently 484 clinical trials looking for individuals with Parkinson's disease (PD) and 2 studies searching to admit participants into RO7046015."

Answered by AI