Clinical Trial Detail | Research

PARAISO/BN44715: 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

Purpose

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.

Inclusion Criteria

Ages Eligible for Study

50 Years to 85 Years (Adult, Older Adult )

Sexes Eligible for Study

All

Accepts 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

NCT: NCT07174310

Timothy A Leichliter, MD

Movement Disorders Neurology

Allegheny General Hospital

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Contact

For more information about this trial, please send an email to ClinicalTrials@ahn.org.

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