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
Plain-Language Summary
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 9 months.