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

NCT07174310

RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Parkinson's Disease

Interventions: Prasinezumab, Placebo

Countries: United States, Australia, Austria, Brazil, Canada, China, Denmark, France

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 overview

Sex: ALL

Age: 50 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (184)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Fullerton, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • Pasadena, California, United States
  • San Francisco, California, United States
  • Stanford, California, United States
  • Englewood, Colorado, United States
  • New Haven, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Atlantis, Florida, United States
  • Boca Raton, Florida, United States
  • Lady Lake, Florida, United States
  • Maitland, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Honolulu, Hawaii, United States
  • Chicago, Illinois, United States
  • Kansas City, Kansas, United States
  • Boston, Massachusetts, United States
  • Farmington Hills, Michigan, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • Reno, Nevada, United States
  • Paramus, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • + 154 more on CT.gov