A Study of Prasinezumab for Early-Stage Parkinson's Disease

This study is looking into how well and how safely a drug called prasinezumab works for people with early-stage Parkinson's disease (PD). You would receive either prasinezumab or a placebo (an inactive substance) through an IV (into your vein). The researchers want to see if prasinezumab can slow down the worsening of motor symptoms (movement problems) over at least 104 weeks, as measured by a special rating scale (MDS-UPDRS Part III). The study aims to enroll about 900 participants. To join, you should be between 50 and 85 years old, weigh between 88 and 242 pounds, and have a diagnosis of idiopathic PD. Your Parkinson's should be at an early stage (Hoehn and Yahr Stage 1 or 2) and you should be taking only one stable medication for your symptoms.

Study design
This is an interventional study comparing prasinezumab to a placebo. It plans to enroll about 900 participants.
What's involved
You would receive either prasinezumab or a placebo as an IV infusion according to a set schedule. The primary outcome is measured for at least 104 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your motor progression will be measured for up to at least Week 104 after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07174310

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Recruiting
PHASE3Ages 50–85InterventionalTreatment
Hoffmann-La Roche
~900 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:PrasinezumabPlacebo

At a glance

Recruiting sites
190 of 192 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
Measured over Up to at least Week 104
Parkinson's Disease

NCT07174310

Where you'd take part

This study runs at 192 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • A.O. Universitaria Pisana

    Pisa, Tuscany, Italyno site contact published

    Recruiting

  • Aarhus Universitetshospital Skejby

    Aarhus N, Denmarkno site contact published

    Recruiting

  • Advent Health Orlando

    Orlando, Floridano site contact published

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvaniano site contact published

    Recruiting

  • AP-HM- Hôpital de La Timone

    Marseille, Bouches-du-Rhône, Franceno site contact published

    Recruiting

  • APHP - Hopital de la Pitie Salpetriere

    Paris, Franceno site contact published

    Recruiting

  • APHP - Hopital Henri Mondor

    Créteil, Franceno site contact published

    Recruiting

  • Asan Medical Center

    Seoul, South Koreano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche
Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below.
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Eligibility criteria

Inclusion

Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2
Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
Has received monotherapy treatment
An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization
Agreement to adhere to the contraception requirements

Exclusion

Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
Medical history indicating a parkinsonian syndrome other than idiopathic PD
Diagnosis of a significant neurologic disease other than PD
Chronic uncontrolled hypertension
  • Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III ScoreUp to at least Week 104