New medication slows early progression
- Trial ID
- NCT07174310
- Official Title
- 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
- Goal
- New medication slows early progression
- Phase
- PHASE3
- Status
- RECRUITING
- Sponsor
- Hoffmann-La Roche
- Study Type
- INTERVENTIONAL
- Enrollment
- 900 participants
- Conditions
- Parkinson's Disease
- Interventions
- Prasinezumab, Placebo
Plain-Language Summary
The goal is to see if prasinezumab can slow early Parkinson's by reducing toxic alpha-synuclein clumps that are thought to drive nerve cell damage and disease progression. Prasinezumab is an intravenous monoclonal antibody that binds aggregated alpha-synuclein to promote its clearance and limit its spread, it is given on top of a single Parkinson's medication and is intended as a potential disease-modifying treatment rather than a symptomatic replacement for levodopa. The trial is enrolling people 50 to 85 years old with idiopathic PD at Hoehn and Yahr stage 1 or 2 who are on stable monotherapy with no motor complications, with standard weight and contraception requirements and exclusions for other neurologic disease, pregnancy, or uncontrolled hypertension.
Locations
- Neurology Center of North Orange County, Fullerton, California, United States
- Keck School of Medicine of USC, Los Angeles, California, United States
- Parkinson?s Research Centers of America ? Palo Alto, Palo Alto, 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
- 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
- Washington Uni School of Medicine, St Louis, Missouri, United States
- Renown Health, Reno, Nevada, United States
- Dent Neurological Institute, Amherst, New York, United States
- Parkinson's Research Centers of America - Long Island, Commack, New York, United States
And 81 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Prasinezumab. The goal is to see if prasinezumab can slow early Parkinson's by reducing toxic alpha-synuclein clumps that are thought to drive nerve cell damage and disease progression. Prasinezumab is an intravenous monoclonal antibody that binds aggregated alpha-synuclein to promote its clearance and limit its spread, it is given on top of a single Parkinson's medication and is intended as a potential disease-modifying treatment rather than a symptomatic replacement for levodopa. The trial is enrolling people 50 to 85 years old with idiopathic PD at Hoehn and Yahr stage 1 or 2 who are on stable monotherapy with no motor complications, with standard weight and contraception requirements and exclusions for other neurologic disease, pregnancy, or uncontrolled hypertension.
- Who can participate?
- Participants must be between 50 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 101 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 3 trial is estimated to last approximately 3 years and 7 months.