Prasinezumab for Parkinson's (NCT07174310)
Slow early Parkinson disease 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
- Slow early Parkinson disease 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 trial is testing whether giving the drug prasinezumab through a vein can help people with early-stage Parkinson's disease who are already taking levodopa, by measuring whether it works, whether it is safe, and how the body handles the drug. Participants are randomly assigned to receive intravenous prasinezumab or a matching placebo, and neither they nor the study staff know who gets which, while they continue their regular levodopa-only treatment. The study seeks adults 50 to 85 years old with early Parkinson's not caused by another condition, with mild disease (stage 1 or 2 when off medication) and within certain weight and body mass ranges; people who are pregnant, have other significant neurologic diseases or other parkinsonian syndromes, or have uncontrolled high blood pressure are excluded.
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
- UC San Diego, La Jolla, California, United States
- Keck School of Medicine of USC, Los Angeles, California, United States
- UCLA Neurology Outpatient Clinic, 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
- Baptist Hospital of Miami, Miami, 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
And 154 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Prasinezumab. The trial is testing whether giving the drug prasinezumab through a vein can help people with early-stage Parkinson's disease who are already taking levodopa, by measuring whether it works, whether it is safe, and how the body handles the drug. Participants are randomly assigned to receive intravenous prasinezumab or a matching placebo, and neither they nor the study staff know who gets which, while they continue their regular levodopa-only treatment. The study seeks adults 50 to 85 years old with early Parkinson's not caused by another condition, with mild disease (stage 1 or 2 when off medication) and within certain weight and body mass ranges; people who are pregnant, have other significant neurologic diseases or other parkinsonian syndromes, or have uncontrolled high blood pressure are excluded.
- Who can participate?
- Participants must be between 50 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 174 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 3 trial is estimated to last approximately 3 years and 7 months.
- 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.
- 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.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Intravenous infusion (minimally invasive). Confirm the full schedule with the study coordinator.