Actively Recruiting
A Natural History Study of Treated Parkinson's Disease Patients Experiencing Motor Complications
Led by Bayer · Updated on 2026-05-18
300
Participants Needed
26
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand how Parkinson's disease progresses over time in patients who continue to have movement symptoms despite taking standard oral Parkinson's medications. The study focuses on patients diagnosed with Parkinson's disease who experience motor complications and seeks to fill gaps left by earlier studies that did not follow these patients long enough or collect comprehensive information. It also looks at the challenges faced by patients and their care partners, as well as how treatments work in real-life settings. Participants in this observational study will not receive any investigational treatments but will continue with the standard care determined by their clinicians. The study includes a single group of Parkinson's disease patients experiencing motor symptoms and may also include their care partners. Data collection spans from December 2025 to December 2032, with each participant followed for up to five years. No changes to participants' healthcare or treatment plans will be made as part of the study. During the study, researchers will collect detailed information through questionnaires, rating scales, patient diaries, medical records, insurance claims, blood samples, skin biopsies, and data from a digital device that tracks symptoms. Care partners will also complete questionnaires. The primary outcomes include summaries of motor and non-motor symptoms, treatments received, and the psychological and economic burden of care over the five-year period. Participants will have regular visits where these assessments and sample collections occur to monitor disease progression and treatment impact.
CONDITIONS
Brief Title
A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite Taking Parkinson's Medications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals of any sex aged 45 to 75 years at consent (at least 30% aged 60 or older)
- Clinically established Parkinson's disease diagnosis within 12 years
- Modified Hoehn and Yahr stage II-III during OFF-medication state
- Score of 30 or higher on MDS-UPDRS part III in OFF-medication state
- Presence of motor fluctuations with at least 1 hour of OFF time daily
- Stable antiparkinsonian medication for at least 4 weeks prior with levodopa dose ≥300 mg or dosing frequency ≥3 times daily
- Responsiveness to levodopa shown by improvement in modified Hoehn and Yahr stage or MDS-UPDRS part III score
- Montreal Cognitive Assessment (MoCA) score of 24 or higher
- Willingness to provide informed consent
You will not qualify if you...
- History or presence of other conditions that could mimic Parkinson's disease
- Significant vascular or cardiovascular diseases such as stroke or uncontrolled hypertension
- History or presence of significant psychosis, impulse control disorder, or untreated depression
- History or presence of infections like HIV, hepatitis B or C, syphilis, or tuberculosis
- Active or recent malignant disease within past 5 years except certain skin or cervical cancers
- Currently pregnant, nursing, or planning pregnancy during the study
- Use of levodopa/carbidopa intestinal gel, subcutaneous levodopa, or apomorphine pump
- Prior brain surgery including deep brain stimulation or experimental neurosurgical procedures
- Participation in cell or gene therapy
- Currently enrolled in any interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 years
Participants with Parkinson's Disease experiencing motor complications while receiving standard-of-care oral therapies are observed to track changes in motor and non-motor symptoms over time.
Periodic visits over 5 years as per clinical practice
Trial Site Locations
Total: 26 locations
1
Banner Alzheimer's Institute (BAI)-Phoenix
Phoenix, Arizona, United States, 85006
Not Yet Recruiting
2
University of Arizona Banner Alzheimer's Institute (BAI)-Tucson
Tucson, Arizona, United States, 85721
Not Yet Recruiting
3
The Parkinson's & Movement Disorder Institute
Fountain Valley, California, United States, 92708
Actively Recruiting
4
Keck School of Medicine
Los Angeles, California, United States, 90033
Actively Recruiting
5
Baptist Health Miami Neuroscience Institute
Miami, Florida, United States, 33176
Not Yet Recruiting
6
AdventHealth Neuroscience Institute
Orlando, Florida, United States, 32804
Not Yet Recruiting
7
University of South Florida
Tampa, Florida, United States, 33612
Not Yet Recruiting
8
Morehouse Healthcare
Atlanta, Georgia, United States, 30310
Not Yet Recruiting
9
Medical College of Georgia at Augusta University
Augusta, Georgia, United States, 30912
Not Yet Recruiting
10
Northwestern Memorial HealthCare at Central DuPage Hospital
Winfield, Illinois, United States, 60190
Not Yet Recruiting
11
MedStar Montgomery Medical Center
Olney, Maryland, United States, 20832
Not Yet Recruiting
12
Boston Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
13
University of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
14
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Not Yet Recruiting
15
Northwell Health
New York, New York, United States, 10016
Not Yet Recruiting
16
Stony Brook University
Stony Brook, New York, United States, 11794
Not Yet Recruiting
17
University of Buffalo
Williamsville, New York, United States, 14221
Not Yet Recruiting
18
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
19
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
20
Baylor College of Medicine
Houston, Texas, United States, 77030
Not Yet Recruiting
21
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
22
Intermountain Health
Murray, Utah, United States, 84107
Not Yet Recruiting
23
University of Vermont
Burlington, Vermont, United States, 05402
Not Yet Recruiting
24
University of Virginia
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
25
Sentara Neurology Specialists
Norfolk, Virginia, United States, 23510
Not Yet Recruiting
26
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Not Yet Recruiting
Research Team
B
Bayer Clinical Trials Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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