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Monoclonal Antibodies

Prasinezumab for Early Parkinson's Disease (PADOVA 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 (H&Y) Stage I or II in OFF medication state at screening and prior to randomization
Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 and after week 76 every 12 weeks therafter until end of study (approximately 28 days after the final dose)
Awards & highlights

PADOVA Trial Summary

This trial will study whether prasinezumab is effective and safe in treating early Parkinson's disease.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, monoclonal antibodies like Prasinezumab can cause allergic reactions, infusion-related reactions (like fever or chills), and possibly affect liver function based on required lab test monitoring.

PADOVA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My Parkinson's is in the early stages (I or II) without medication.
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I have been diagnosed with Parkinson's disease based on movement symptoms.
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My Parkinson's disease medication will stay the same during the study.
Select...
I have no motor complications from Parkinson's disease.

PADOVA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
OLE: Change from Baseline in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
OLE: Number of Participants with Adverse Events of Special Interest (AESI)
OLE: Number of Participants with Infusion Related Reactions (IRRs)
+2 more
Secondary outcome measures
Change from Baseline in Suicidal Ideation, as Measured by the C-SSRS
Change in Bradykinesia and Rigidity from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia and Rigidity Subscore
Change in Motor Function from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Score
+10 more

PADOVA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PrasinezumabExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention
Participants will receive placebo as an IV infusion Q4W.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,300 Total Patients Enrolled
Prothena Biosciences LimitedIndustry Sponsor
7 Previous Clinical Trials
579 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,017 Total Patients Enrolled

Media Library

Prasinezumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04777331 — Phase 2
Parkinson's Disease Research Study Groups: Prasinezumab, Placebo
Parkinson's Disease Clinical Trial 2023: Prasinezumab Highlights & Side Effects. Trial Name: NCT04777331 — Phase 2
Prasinezumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04777331 — Phase 2
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04777331 — Phase 2

Frequently Asked Questions

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

How might Prasinezumab present risks for patients?

"At Power, we gave Prasinezumab a score of 2 out of 3 in regards to safety. This is because, although there is data supporting its safety profile, there are no clinical studies yet demonstrating its efficacy."

Answered by AI

How can I become a test subject in this experiment?

"This clinical trial is looking for 575 people with parkinson disease between the ages of 50 and 85. The patients must meet the following criteria: -Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism -On symptomatic PD medication, with stable doses for at least 3 months prior to baseline -A diagnosis of PD for at least 3 months to maximum 3 years at screening -MDS-U"

Answered by AI

Could you tell me if Prasinezumab has been used in other research programs?

"There are currently 2 clinical trials involving prasinezumab with 0 being in the final stage of testing. Most of these studies are taking place in St Herblain and Lazio, but there are a total of 201 locations running similar trials."

Answered by AI

Is it possible to join this research project at the present time?

"That is correct, the online clinicaltrials.gov registry shows that this research project is still looking for patients. This listing was first put up on May 5th, 2021 and was most recently updated November 4th, 2022. In total, they are hoping to enroll 575 people at 37 different sites."

Answered by AI

Has this type of clinical trial been conducted before?

"Since 2017, when the first 316-person study was conducted by Hoffmann-La Roche, prasinezumab has been under clinical investigation. In Phase 2 drug trials, the medication received approval and today there are 2 active global studies involving 82 cities and 10 nations."

Answered by AI

In how many hospitals is this trial currently being conducted?

"There are 37 clinical trial sites for this study, including the University of Florida Center For Movement Disorders And Neurorestoration in Gainesville, Florida, Wr-Crcn, Llc in Las Vegas, Nevada and Yale University in New Haven, Connecticut."

Answered by AI

How many individuals are part of this research initiative?

"To ensure that this clinical trial runs smoothly, 575 participants are needed. These individuals must meet specific inclusion criteria and can come from different locations, such as University of Florida Center For Movement Disorders And Neurorestoration in Gainesville or Wr-Crcn, Llc in Las Vegas."

Answered by AI

Are patients who are middle-aged or older eligible for this research?

"This particular study is only open to patients aged 50-85. In contrast, there are 28 clinical trials for people under 18 and 516 for those over 65."

Answered by AI

Who else is applying?

What state do they live in?
Washington
Illinois
Other
California
How old are they?
65+
What site did they apply to?
UC San Diego
Raleigh Neurology Associates
Sentara Neurology Specialists
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
3+

Why did patients apply to this trial?

Iam a patient of PD and I want to be part of the cure. I am the son of scientists who believes in scientific research.
PatientReceived 2+ prior treatments
Back in September my doctor had me get a DATSCAN and the results had shown positive for pre-Parkinsons. My doctor had me try two different prescriptions and was able to finalize one that I am presently taking. Any steps I can take would be a step in the right direction.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What is involved and what medications or procedures will be taken? How many visits to the facility is required and how long will this study be for?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
2021. "A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04777331.
All > Parkinsons Disease
~59 spots leftby Sep 2024
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