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
Summary For Families
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
- University of Alabama at Birmingham, Birmingham, Alabama, United States
- Barrow Neurological Institute, Phoenix, Arizona, United States
- 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
- Georgetown University, Washington D.C., District of Columbia, 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
- Northwestern University Feinberg School Of Medicine, Chicago, 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
And 122 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 142 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.