A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Parkinsons Disease

In brief

This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.

Key facts

Study ID

NCT04777331

Run by

Hoffmann-La Roche

People needed

586

Starts

2021-05-05

Expected to finish

2031-06-30

Last updated by the study team

2026-06-23

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism
• On symptomatic PD medication, with stable doses for at least 3 months prior to baseline
• A diagnosis of PD for at least 3 months to maximum 3 years at screening
• MDS-UPDRS Part IV score of 0 at screening and prior to randomization
• Hoehn and Yahr (H\&Y) Stage I or II in OFF medication state at screening and prior to randomization
• Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader
• No anticipated changes in PD medication from baseline throughout the study duration based on clinical status during screening
• Willingness and ability to use a smartphone application to measure PD-related symptoms for the duration of the study
• Willingness and ability to wear a smartwatch to measure PD-related motor signs

You may not qualify if…

• Medical history indicating a Parkinsonian syndrome other than idiopathic PD
• Diagnosis of PD dementia
• Diagnosis of a significant neurologic disease other than PD
• Within the last year, unstable or clinically significant cardiovascular disease
• Uncontrolled hypertension
• Drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (Nicotine is allowed, Marijuana use is not allowed)
• Clinically significant abnormalities in laboratory test results at the screening visit, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis
• Allergy to any of the components of prasinezumab, a known hypersensitivity, or a previous IRR following administration of any other monoclonal antibody
• Any contraindications to obtaining a brain magnetic resonance imaging (MRI)
• Any contraindications to DaT-SPECT imaging

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• UC San Diego — La Jolla, California, United States
• Keck School of Medicine of USC — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• CenExel Rocky Mountain Clinical Research, LLC — 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
• Renstar Medical Research — Ocala, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Charter Research - Winter Park/Orlando — Winter Park, Florida, United States
• Northwestern University Feinberg School Of Medicine — Chicago, Illinois, United States
• Southern Illinois University, School of Medicine — Springfield, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Quest Research Institute — Farmington Hills, Michigan, United States
• Henry Ford Hospital — West Bloomfield, Michigan, United States
• Dent Neurological Institute — Amherst, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Movement Disorder Clinic of Oklahoma — Tulsa, Oklahoma, United States
• University Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Texas Neurology PA — Dallas, Texas, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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