About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Prasinezumab
- Placebo
Treatment groups
Locations
160Sponsors and collaborators
Hoffmann-La Roche
Lead sponsor
Prothena Biosciences Limited
Collaborator