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Major study launches to unravel Parkinson's mysteries in patients with persistent movement problems

NCT ID NCT07330258

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This study follows 300 people with Parkinson's disease who still have movement symptoms despite taking standard medications. Researchers will collect data over up to 5 years through questionnaires, diaries, medical records, blood samples, and a digital device. The goal is to better understand how the disease changes over time and what challenges patients and their caregivers face in real life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with Parkinson's disease experiencing motor complications while on antiparkinsonian medications

Ages

45 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth Neuroscience Institute

    NOT_YET_RECRUITING

    Orlando, Florida, 32804, United States

  • Banner Alzheimer's Institute (BAI)-Phoenix

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Baptist Health Miami Neuroscience Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • Baylor College of Medicine

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Boston Medical Center

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Intermountain Health

    NOT_YET_RECRUITING

    Murray, Utah, 84107, United States

  • Keck School of Medicine

    RECRUITING

    Los Angeles, California, 90033, United States

  • MedStar Montgomery Medical Center

    NOT_YET_RECRUITING

    Olney, Maryland, 20832, United States

  • Medical College of Georgia at Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Morehouse Healthcare

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30310, United States

  • Northwell Health

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Northwestern Memorial HealthCare at Central DuPage Hospital

    NOT_YET_RECRUITING

    Winfield, Illinois, 60190, United States

  • Rutgers - Robert Wood Johnson Medical School

    NOT_YET_RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Sentara Neurology Specialists

    WITHDRAWN

    Norfolk, Virginia, 23510, United States

  • Stony Brook University

    NOT_YET_RECRUITING

    Stony Brook, New York, 11794, United States

  • The Parkinson's & Movement Disorder Institute

    RECRUITING

    Fountain Valley, California, 92708, United States

  • Thomas Jefferson University

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • University of Arizona - Movement Disorder Clinic

    NOT_YET_RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Buffalo Jacobs School of Medicine

    RECRUITING

    Williamsville, New York, 14203, United States

  • University of Michigan

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of South Florida

    NOT_YET_RECRUITING

    Tampa, Florida, 33612, United States

  • University of Texas Health Science Center at Houston

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • University of Vermont

    NOT_YET_RECRUITING

    Burlington, Vermont, 05402, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • VA Puget Sound Health Care System

    NOT_YET_RECRUITING

    Seattle, Washington, 98108, United States

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

    NOT_YET_RECRUITING

    New Haven, Connecticut, 06510, United States

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