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
- Registry Record Last Updated
- 2026-07-28 (this month)
- Estimated Commitment
- Moderate commitment estimated from the protocol (based on: invasive procedure). This reflects time and procedures only — confirm details with the study coordinator.
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.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Levodopa: Must be taking levodopa (criteria text: "* receiving stable antiparkinsonian medication regimen for >=4 weeks prior to screening with a levodopa daily dose >=300 mg or a dosing frequency of >=3 time...")
- Medication dose: Must be on a stable dose of Parkinson's medication (criteria text: "* receiving stable antiparkinsonian medication regimen for >=4 weeks prior to screening with a levodopa daily dose >=300 mg or a dosing frequency of >=3 time...")
- Motor fluctuations: Must have motor fluctuations (off periods when medication wears off) (criteria text: "* presence of motor fluctuations with >=1 hour of absolute time in the off state per day as assessed by clinician/patient at screening")
- Deep brain stimulation: Cannot join after DBS surgery (deep brain stimulation) (criteria text: "* prior history of brain surgery, including but not limited to: deep brain stimulation (dbs), pallidotomy, focused ultrasound thalamotomy, or other experimen...")
- Time since diagnosis: Diagnosed between 4 years and 12 years ago (criteria text: "* Diagnosis of clinically established Parkinson's disease (PD) as defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD ≥4 and \<12 years from time of PD diagnosis at informed consent.")
- Thinking test (MoCA): MoCA memory and thinking score of at least 24 (criteria text: "* montreal cognitive assessment (moca) score of >=24")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial enrolls people aged 45 to 75.
- This trial does not enroll people who have had (or are scheduled for) DBS surgery.
- This trial requires participants to be taking levodopa.
- This trial requires a Parkinson's diagnosis between 4 years and 12 years ago.
- This trial requires motor fluctuations (off periods).
- This trial requires a MoCA thinking-test score of at least 24.
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.
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07330258. It is the one about "Document motor complications despite medication". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take?
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: 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. Ask the coordinator to confirm it still applies.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
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?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; 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 trial is estimated to last approximately 6 years and 5 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.