Actively Recruiting

Age: 45Years - 75Years
All Genders
NCT07330258

A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite Taking Parkinson's Medications

Led by Bayer · Updated on 2026-04-20

300

Participants Needed

5

Research Sites

369 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an observational study in which data are collected and studied from Parkinson's disease patients who have movement symptoms despite taking standard Parkinson's medications. In observational studies, observations are made without any changes to the participant's healthcare or treatment plan. No investigational product will be administered in this study, as participants will be treated with the standard of care that medical experts currently consider most appropriate. Parkinson's disease (PD) is a condition that affects the brain and causes problems with movement and other body functions. The symptoms of Parkinson's disease can worsen over time. People with Parkinson's disease may experience shaking (tremor), slow movements, stiff muscles, trouble walking, and problems with balance. They can also have other symptoms, such as difficulty thinking clearly, changes in mood, or difficulty sleeping. Parkinson's disease mostly affects older adults, but it can happen to younger people too. There is no cure, but treatments can help manage the symptoms and improve quality of life. While doctors and researchers know that Parkinson's disease affects people in different ways and can worsen over time, there are still many things they don't fully understand-especially for people who experience movement symptoms despite taking their usual Parkinson's medicines. Earlier studies did not follow these patients long enough or collect all the important information needed. This study is being done to fill those gaps. The main purpose of this study is to better understand how Parkinson's disease changes over time in patients who experience movement symptoms while taking standard oral Parkinson's medications, what challenges patients and their care partners face, and how their treatments are working in real life. To do this, researchers will collect data on: * Sociodemographics (e.g. age, gender, race/ethnicity, insurance provider). * Medical history and vital signs (e.g. comorbidities, family history of Parkinson's, height, weight, blood pressure). * Medications and treatments (e.g. Parkinson's and non-Parkinson's medications and other treatments, rehabilitation therapy sessions, use of mobility assistance devices). * Movement symptoms (e.g. tremor, slow movement, balance). * Non-movement symptoms (e.g. cognition, mood, sleep, activities of daily living). * Molecular data (e.g. genetics, α-synuclein). * Burden of care (e.g. economic cost). Data will come from questionnaires or rating scales conducted by the doctor with the patient during study visits, diaries and logs completed by the patient, medical records, health insurance claims records, blood samples and skin biopsies, a digital device that records movement/non-movement symptoms, and questionnaires completed by the care partner. Data will be collected from December 2025 to December 2032. Each participant may be followed for up to 5 years.

CONDITIONS

Official 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

Age: 45Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 45 and 75 years at informed consent, with at least 30% aged 60 or older
  • Clinically established Parkinson's disease diagnosis within 12 years
  • Modified Hoehn and Yahr stage II-III in OFF-medication state (at least 12 hours from last medication dose)
  • MDS-UPDRS part III score of 30 or higher in OFF-medication state
  • Presence of motor fluctuations with at least 1 hour of OFF time per day
  • Stable antiparkinsonian medication regimen for at least 4 weeks prior to screening with levodopa dose of 300 mg or more daily or dosing frequency of 3 or more times per day
  • Responsiveness to levodopa shown by any improvement in modified Hoehn and Yahr stage or 30% improvement in MDS-UPDRS part III score
  • Montreal Cognitive Assessment score of 24 or higher
  • Agree to participate and provide signed informed consent
  • Care partner aged 18 or older identified by patient and able to provide consent independently
Not Eligible

You will not qualify if you...

  • History or presence of conditions that could explain symptoms other than Parkinson's disease, including multiple system atrophy, progressive supranuclear palsy, corticobasal syndrome, vascular Parkinsonism, drug-induced Parkinsonism, essential tremor, Lewy body dementia, Huntington's disease, Wilson's disease, Alzheimer's disease, cerebrovascular disease, brain tumor, trauma, or infection
  • Significant vascular or cardiovascular diseases such as stroke, transient ischemic attacks, uncontrolled hypertension or diabetes, unstable angina, or myocardial infarction
  • Significant psychosis, impulse control disorder, or untreated/suboptimally treated depression
  • History or presence of HIV, hepatitis B or C, syphilis, or tuberculosis
  • Active or recent (within 5 years) malignant disease except certain treated skin or cervical cancers
  • Currently pregnant, nursing, lactating, breastfeeding, or planning pregnancy during the study
  • Use of levodopa/carbidopa intestinal gel, subcutaneous levodopa, or apomorphine pumps
  • Prior brain surgery including deep brain stimulation or other experimental neurosurgical procedures
  • History or current participation in cell or gene therapy procedures
  • Current participation in any interventional clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

The Parkinson's & Movement Disorder Institute

Fountain Valley, California, United States, 92708

Actively Recruiting

2

Keck School of Medicine

Los Angeles, California, United States, 90033

Actively Recruiting

3

Boston University

Boston, Massachusetts, United States, 02215

Not Yet Recruiting

4

University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Not Yet Recruiting

5

University of Vermont

Burlington, Vermont, United States, 05402

Not Yet Recruiting

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Research Team

B

Bayer Clinical Trials Contact

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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