RECRUITINGPhase 3INTERVENTIONAL
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
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
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Prasinezumab
Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
DRUG
Placebo
Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol
Locations (20)
Neurology Center of North Orange County
Fullerton, California, United States
Keck School of Medicine of USC
Los Angeles, California, United States
Profound Research LLC at The Neurology Center of Southern California
Pasadena, California, United States
UCSF Weill Institute for Neurosciences
San Francisco, California, United States
Rocky Mountain Movement Disorders
Englewood, Colorado, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
JEM Research LLC
Atlantis, Florida, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
K2 - Villages
Lady Lake, Florida, United States
K2 Medical Research-Maitland
Maitland, Florida, United States
Charter Research - Winter Park/Orlando
Orlando, Florida, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Renown Health
Reno, Nevada, United States
Dent Neurological Institute
Amherst, New York, United States
Weill Cornell Medical College
New York, New York, United States
NeuroCare Center
Canton, Ohio, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States
Veracity Neuroscience
Memphis, Tennessee, United States
Texas Neurology PA
Dallas, Texas, United States