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

Neurodegenerative Disorder
Parkinson's Disease (PD)

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 3

Study Identifier NCT07174310, BN44715, 2025-522683-32-00

Condition Parkinson's Disease

Official Title A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early-Stage Parkinson's Disease

Study Summary

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.

Eligibility Criteria

Gender

All

Age

≥50 Years & ≤ 85 Years

Healthy Volunteers

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

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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

For the latest version of this information please go to www.forpatients.roche.com