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.
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
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
Parallel
Prasinezumab
DrugParticipants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
Placebo
DrugParticipants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol
Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
Change From Baseline in Motor Function as Measured by the MDS-UPDRS Part III off Medication Score
Time to Worsening of Participants Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event
Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C), Overall Disease Subscale
Time to increase in Levodopa Equivalent Daily Dose (LEDD)
Click on the lead sponsor to view all of their trials.
Hoffmann-La Roche
Lead sponsor
Prothena Biosciences Limited
Collaborator
