Standard of Care for Parkinson's (NCT07330258)
Document motor complications despite medication
- Trial ID
- NCT07330258
- Official Title
- A Natural History Study of Treated Parkinson's Disease Patients Experiencing Motor Complications
- Goal
- Document motor complications despite medication
- Status
- RECRUITING
- Sponsor
- Bayer
- Study Type
- OBSERVATIONAL
- Enrollment
- 300 participants
- Conditions
- Parkinson's Disease
- Interventions
- Standard of Care
Summary For Families
Goal: Learn how motor complications and OFF time progress over time in people with Parkinson's who are already being treated with levodopa, so researchers can better describe symptom patterns and treatment responses. Approach: Participants stay on their usual care while the team regularly records motor ratings, ON/OFF response to the first daily dose, medication use, and other clinical measures; no new drug or device is given. Eligibility: Adults 45 to 75 years old with clinically established PD diagnosed 4 to under 12 years ago, Hoehn and Yahr stage II,III OFF, MDS‑UPDRS part III score ≥30 OFF, at least 1 hour OFF time per day, on a stable levodopa regimen (≥300 mg/day or ≥3 doses/day) with a clear levodopa response, MoCA ≥24; people with prior DBS or levodopa pumps, major uncontrolled medical or psychiatric conditions, pregnancy, or current interventional trial participation are excluded, and a care partner aged ≥18 may also join.
Locations
- Banner Alzheimer's Institute (BAI)-Phoenix, Phoenix, Arizona, United States
- University of Arizona Banner Alzheimer's Institute (BAI)-Tucson, Tucson, Arizona, United States
- The Parkinson's & Movement Disorder Institute, Fountain Valley, California, United States
- Keck School of Medicine, Los Angeles, California, United States
- Baptist Health Miami Neuroscience Institute, Miami, Florida, United States
- AdventHealth Neuroscience Institute, Orlando, Florida, United States
- University of South Florida, Tampa, Florida, United States
- Morehouse Healthcare, Atlanta, Georgia, United States
- Medical College of Georgia at Augusta University, Augusta, Georgia, United States
- Northwestern Memorial HealthCare at Central DuPage Hospital, Winfield, Illinois, United States
- MedStar Montgomery Medical Center, Olney, Maryland, United States
- Boston Medical Center, Boston, Massachusetts, United States
- University of Michigan, Ann Arbor, Michigan, United States
- Rutgers - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
- Northwell Health, New York, New York, United States
- Stony Brook University, Stony Brook, New York, United States
- University of Buffalo, Williamsville, New York, United States
- Cleveland Clinic, Cleveland, Ohio, United States
- Thomas Jefferson University, Philadelphia, Pennsylvania, United States
- Baylor College of Medicine, Houston, Texas, United States
And 6 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Standard of Care. Goal: Learn how motor complications and OFF time progress over time in people with Parkinson's who are already being treated with levodopa, so researchers can better describe symptom patterns and treatment responses. Approach: Participants stay on their usual care while the team regularly records motor ratings, ON/OFF response to the first daily dose, medication use, and other clinical measures; no new drug or device is given. Eligibility: Adults 45 to 75 years old with clinically established PD diagnosed 4 to under 12 years ago, Hoehn and Yahr stage II,III OFF, MDS‑UPDRS part III score ≥30 OFF, at least 1 hour OFF time per day, on a stable levodopa regimen (≥300 mg/day or ≥3 doses/day) with a clear levodopa response, MoCA ≥24; people with prior DBS or levodopa pumps, major uncontrolled medical or psychiatric conditions, pregnancy, or current interventional trial participation are excluded, and a care partner aged ≥18 may also join.
- Who can participate?
- Participants must be between 45 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 26 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 trial is estimated to last approximately 6 years and 6 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.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Biopsy (invasive); Blood draw (minimally invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.