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
Hoffmann-La Roche
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
- Age range
- 50–85 years
- Sex
- All
- 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 fr…
Interventions
- DrugPrasinezumab
Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
- DrugPlacebo
Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol
Locations (142)
- University of Alabama at BirminghamBirmingham, Alabama
- Barrow Neurological InstitutePhoenix, Arizona
- Neurology Center of North Orange CountyFullerton, California
- Keck School of Medicine of USCLos Angeles, California
- Parkinson?s Research Centers of America ? Palo AltoPalo Alto, California
- Profound Research LLC at The Neurology Center of Southern CaliforniaPasadena, California