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RecruitingPhase 3

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

Hoffmann-La Roche · with Prothena Biosciences Limited · NCT07174310

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50–85 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
900
US sites recruiting
53
Study start
November 24, 2025
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.

Being studied: Prasinezumab; Placebo

Conditions: Parkinson's Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Recruiting US locations

Study contacts (from the official record)

  • Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below. · 888-662-6728 (U.S. and Canada) · global-roche-genentech-trials@gene.com
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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A Study to Evaluate the Efficacy and Safety of Intravenous (IV)… (NCT07174310) | Bored Studies