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RecruitingPhase 3

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests prasinezumab, given through a vein, against a placebo (a treatment with no active drug). It looks at how well the drug works, its safety, and how the body handles it. It is for people with early-stage Parkinson’s disease who take a steady dose of levodopa as their only medicine for symptoms.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Weigh 88–242 pounds (40–110 kg) and have a body mass index (BMI) of 18–34. BMI compares weight with height.
  • Have Parkinson’s disease with no known cause, diagnosed using Movement Disorder Society guidelines.
  • Have received treatment with just one medicine.
  • Score 0 on Part IV of the MDS-UPDRS, a scale for movement problems linked to treatment, at screening and before assignment to a study group.
  • Have stage 1 or 2 Parkinson’s disease on the Hoehn and Yahr scale while off medicine, at screening and before assignment to a study group.
  • Agree to follow the birth control rules.

Who can't join

  • Are pregnant, breastfeeding, or plan to become pregnant during the study or while birth control is required.
  • Have a history of a different condition that causes Parkinson’s-like symptoms.
  • Have another major disease of the brain or nerves besides Parkinson’s disease.
  • Have long-term high blood pressure that is not controlled.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (53)

AL

AZ

CA

CO

CT

DC

FL

GA

HI

IL

KS

MA

MI

MO

NC

NJ

  • Hackensack University Medical Center;Department of Neurology, Neuroscience Institute · Paramus, NJ 07652More trials in Paramus

NM

NV

NY

OH

OK

OR

PA

SD

TN

TX

VA

VT

WV