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
- The Parkinson's & Movement Disorder Institute, Fountain Valley, California, United States
- Keck School of Medicine, Los Angeles, California, United States
- Boston University, Boston, Massachusetts, United States
- University of Texas Health Science Center at Houston, Houston, Texas, United States
- University of Vermont, Burlington, Vermont, United States
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 5 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 8 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.