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Following people who still have movement symptoms on medicine

Researchers in the United States observe how Parkinson’s changes in people whose movement symptoms continue despite standard medication.

Learning by observing or collecting information · Study reference: NCT07330258

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

Who can join?

Ages 45 years to 75 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria for Patient: * Individual of any sex ≥45 to ≤75 years of age at informed consent (at least 30% ≤60 years of age). * 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. * Modified H\&Y stage II-III in the practically defined OFF-medication state (≥12 hours from last dose of antiparkinsonian medications). * Score of ≥30 on MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III in the OFF-medication state. * Presence of motor fluctuations with ≥1 hour of absolute time in the OFF state per day as assessed by clinician/patient at screening. * Receiving stable antiparkinsonian medication regimen for ≥4 weeks prior to screening with a levodopa daily dose ≥300 mg or a dosing frequency of ≥3 times per day. * Responsiveness to levodopa as determined by change in the following measures from the practically defined OFF state to ON state after taking typical first-daily dose of PD-medications: i. any degree of improvement (≥0.5 point) in modified H\&Y stage OR. ii. ≥30% improvement in MDS-UPDRS part III score. * Montreal Cognitive Assessment (MoCA) score of ≥24. * Agree to participate and provide signed informed consent. Exclusion Criteria for Patient: * Known history or presence of conditions that may provide an alternative to a PD diagnosis including but not limited to: multiple system atrophy, progressive supranuclear palsy, striatonigral degeneration, corticobasal syndrome/degeneration, vascular Parkinsonism, drug-induced Parkinsonism, essential tremor, diffuse Lewy body disease, Lewy body dementia, Huntington's disease, Wilson's disease, Fahr's disease, Alzheimer's disease, cerebrovascular disease, brain tumor, trauma, and infection. * Known history or presence of significant vascular and/or cardiovascular disease limited to: stroke, transient ischemic attacks, poorly controlled hypertension, poorly controlled diabetes, unstable angina pectoris, or unstable myocardial infarction. * Known history or presence of significant psychosis or impulse control disorder, or untreated or sub optimally treated depression. * Known history or presence of human immunodeficiency virus, hepatitis B virus, hepatitis C virus, syphilis, or tuberculosis. * Current or previously active malignant disease within the past 5 years, except definitively treated cutaneous squamous cell carcinoma, basal cell carcinoma, or in situ uterine cervical carcinoma. * Currently pregnant, nursing, lactating, breastfeeding, or plan to be during study duration. * Known history or current use of percutaneous levodopa/carbidopa intestinal gel, subcutaneous levodopa, or apomorphine pump. * Prior history of brain surgery, including but not limited to: deep brain stimulation (DBS), pallidotomy, focused ultrasound thalamotomy, or other experimental neurosurgical procedure. * Known history or current participation in cell or gene therapy procedures. * Current participation in any interventional clinical trial. Inclusion Criteria for Care Partner: * ≥18 years of age at informed consent. * Identified by the PD patient as their primary care partner. * Agree to participate and the ability to provide signed informed consent independently, without the need for a legal representative. Exclusion Criteria for Care Partner: * Not applicable.
Full study name & original research details

Official study title

A Natural History Study of Treated Parkinson's Disease Patients Experiencing Motor Complications

Short title used by the registry

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

Original description

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 reported: Parkinson's Disease

Study type
Observational
Interventions
Standard of Care
Phases
Not reported
Sponsor
Bayer
Start date reported by registry
2026-07-21 (actual)

Registry updated: 2026-09-04 · Status last verified by the registry submitter: 2026-07

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Bayer Clinical Trials Contact · (+)1-888-84 22937 · clinical-trials-contact@bayer.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Banner Alzheimer's Institute (BAI)-Phoenix

Phoenix, Arizona, United States

Recruiting

University of Arizona - Movement Disorder Clinic

Tucson, Arizona, United States

Not yet recruiting

The Parkinson's & Movement Disorder Institute

Fountain Valley, California, United States

Recruiting

Keck School of Medicine

Los Angeles, California, United States

Recruiting

Yale School of Medicine's Stephen and Denise Adams Center for Parkinson's Disease Research

New Haven, Connecticut, United States

Not yet recruiting

Baptist Health Miami Neuroscience Institute

Miami, Florida, United States

Recruiting

AdventHealth Neuroscience Institute

Orlando, Florida, United States

Not yet recruiting

University of South Florida

Tampa, Florida, United States

Not yet recruiting

Morehouse Healthcare

Atlanta, Georgia, United States

Not yet recruiting

Medical College of Georgia at Augusta University

Augusta, Georgia, United States

Recruiting

Northwestern Memorial HealthCare at Central DuPage Hospital

Winfield, Illinois, United States

Not yet recruiting

MedStar Montgomery Medical Center

Olney, Maryland, United States

Not yet recruiting

Boston Medical Center

Boston, Massachusetts, United States

Not yet recruiting

University of Michigan

Ann Arbor, Michigan, United States

Not yet recruiting

Rutgers - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Not yet recruiting

Northwell Health

New York, New York, United States

Not yet recruiting

Stony Brook University

Stony Brook, New York, United States

Not yet recruiting

University of Buffalo Jacobs School of Medicine

Williamsville, New York, United States

Recruiting

Cleveland Clinic

Cleveland, Ohio, United States

Not yet recruiting

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Not yet recruiting

Baylor College of Medicine

Houston, Texas, United States

Not yet recruiting

University of Texas Health Science Center at Houston

Houston, Texas, United States

Not yet recruiting

Intermountain Health

Murray, Utah, United States

Not yet recruiting

University of Vermont

Burlington, Vermont, United States

Not yet recruiting

University of Virginia

Charlottesville, Virginia, United States

Recruiting

Sentara Neurology Specialists

Norfolk, Virginia, United States

Withdrawn

VA Puget Sound Health Care System

Seattle, Washington, United States

Not yet recruiting

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.