A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT07174310

Run by

Hoffmann-La Roche

People needed

900

Starts

2025-11-24

Expected to finish

2031-06-30

Last updated by the study team

2026-08-06

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States (enrolling)
• Neurology Center of North Orange County — Fullerton, California, United States (enrolling)
• UC San Diego — La Jolla, California, United States (enrolling)
• Keck School of Medicine of USC — Los Angeles, California, United States (enrolling)
• UCLA Neurology Outpatient Clinic — Los Angeles, California, United States (enrolling)
• Parkinson?s Research Centers of America ? Palo Alto — Palo Alto, California, United States (enrolling)
• Profound Research LLC at The Neurology Center of Southern California — Pasadena, California, United States (enrolling)
• UCSF Weill Institute for Neurosciences — San Francisco, California, United States (enrolling)
• Stanford Neuroscience Health Center (SNHC) — Stanford, California, United States (enrolling)
• Rocky Mountain Movement Disorders — Englewood, Colorado, United States (enrolling)
• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States (enrolling)
• Georgetown University — Washington D.C., District of Columbia, United States (enrolling)
• JEM Research LLC — Atlantis, Florida, United States (enrolling)
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States (enrolling)
• K2 - Villages — Lady Lake, Florida, United States (enrolling)
• K2 Medical Research-Maitland — Maitland, Florida, United States (enrolling)
• Baptist Hospital of Miami — Miami, Florida, United States (enrolling)
• Charter Research - Winter Park/Orlando — Orlando, Florida, United States (enrolling)
• Advent Health Orlando — Orlando, Florida, United States (enrolling)
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States (enrolling)
• Northwestern University Feinberg School Of Medicine — Chicago, Illinois, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Quest Research Institute — Farmington Hills, Michigan, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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