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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
No
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
Sponsor
Hoffmann-La Roche
Contact
For more information about this trial, please send an email to ClinicalTrials@ahn.org.