Parkinson's DiseaseNCT07330258
A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite Taking Parkinson's Medications
An observational study of Parkinson's Disease, run by Bayer at 27 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson's Disease
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 27 sitesUnited States
- Study dates
- 21 Jul 2026to 1 Jun 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's disease experiencing motor complications while on antiparkinsonian medications
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
- ≥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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
- Not applicable.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
United States27 sites, 26 recruiting
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Not yet recruiting
Morehouse Healthcare
Atlanta, Georgia, 30310
- Recruiting
Medical College of Georgia at Augusta University
Augusta, Georgia, 30912
- Not yet recruiting
Boston Medical Center
Boston, Massachusetts, 02215
- Not yet recruiting
University of Vermont
Burlington, Vermont, 05402
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
The Parkinson's & Movement Disorder Institute
Fountain Valley, California, 92708
- Not yet recruiting
Baylor College of Medicine
Houston, Texas, 77030
- Not yet recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
- Recruiting
Keck School of Medicine
Los Angeles, California, 90033
- Recruiting
Baptist Health Miami Neuroscience Institute
Miami, Florida, 33176
- Not yet recruiting
Intermountain Health
Murray, Utah, 84107
- Not yet recruiting
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
- Not yet recruiting
Yale School of Medicine's Stephen and Denise Adams Center for Parkinson's Disease Research
New Haven, Connecticut, 06510
- Not yet recruiting
Northwell Health
New York, New York, 10016
- Withdrawn
Sentara Neurology Specialists
Norfolk, Virginia, 23510
- Not yet recruiting
MedStar Montgomery Medical Center
Olney, Maryland, 20832
- Not yet recruiting
AdventHealth Neuroscience Institute
Orlando, Florida, 32804
- Not yet recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
- Recruiting
Banner Alzheimer's Institute (BAI)-Phoenix
Phoenix, Arizona, 85006
- Not yet recruiting
VA Puget Sound Health Care System
Seattle, Washington, 98108
- Not yet recruiting
Stony Brook University
Stony Brook, New York, 11794
- Not yet recruiting
University of South Florida
Tampa, Florida, 33612
- Not yet recruiting
University of Arizona - Movement Disorder Clinic
Tucson, Arizona, 85719
- Recruiting
University of Buffalo Jacobs School of Medicine
Williamsville, New York, 14203
- Not yet recruiting
Northwestern Memorial HealthCare at Central DuPage Hospital
Winfield, Illinois, 60190
About this study
Official title: A Natural History Study of Treated Parkinson's Disease Patients Experiencing Motor Complications
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.
Read more
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
- Parkinson's Disease
- Being tested
- Standard of Care
- Keywords
- Natural history study, Parkinson's disease, PD Motor (Hauser) Diary, MDS-UPDRS, Electronic health/medical records, Administrative claims data, Biological samples, Digital health technology, Care partner
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Follow clinical practice/administration. No investigational products will be administered in this study. Patients will be treated in accordance with standard of care as determined by their clinician.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease Cohort | A single cohort of patients with Parkinson's disease experiencing motor complications while receiving standard-of-care oral therapies. The care partner of the patient may also participate in the study. Receives: Other: Standard of Care | |
| Care Partners Cohort | The care partner of the patient may also participate in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive summary of motor outcomes among Parkinson's disease patients treated with oral antiparkinsonian medications who experience motor complications.
This outcome will be assessed using Parkinson's disease (PD) Motor (Hauser) Diary, Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II-IV (each part has several items scored from 0-normal to 4-severe; with higher scores indicating greater impairment), modified Hoehn \& Yahr (stages Parkinson's disease severity from 1 [unilateral involvement only] to 5 [wheelchair-bound or bedridden unless aided]), Universal Dyskinesia Rating Scale (UDysRS) (items scored from 0-none to 4-severe; higher scores indicate more severe dyskinesia), medical records, and digital health technology.
Measured: From baseline up to 5 years
Descriptive summary of non-motor outcomes among Parkinson's disease patients treated with oral antiparkinsonian medications who experience motor complications.
This outcome will be assessed using Montreal Cognitive Assessment (MoCA, score 0-30, higher = better cognition), MDS-UPDRS I (4-point scale, higher = greater impairment), modified Schwab \& England Activities of Daily Living (0-100%, higher = greater independence), MDS Non-Motor Rating Scale (MDS-NMS, 4-point scale, higher = more severe non-motor symptoms), Parkinson's Disease Questionnaire-39 (PDQ-39, 0-100 scale, higher = worse quality of life), Parkinson's Disease Health Index (PD-HI, higher = worse health status), Parkinson's Disease Sleep Scale 2 (PDSS-2, 4-point scale, higher = more severe sleep problems), Clinical Global Impressions Severity (CGI-S, 7-point scale, higher = greater severity of illness), Patient Global Impression Severity (PGI-S, 7-point scale, higher = greater severity), EuroQoL 5-Dimension 5-Level (EQ-5D-5L, 5 dimensions, 5 levels, plus visual analogue scale (VAS) 0-100 [100=best imaginable health]), medical records, and digital health technology.
Measured: From baseline up to 5 years
Descriptive summary of Parkinson's medications and treatments received
This outcome will be assessed by the logs (Parkinson's medications, Parkinson's advanced therapies, rehabilitation therapies \& mobility assistance devices) completed by the patient, medical records, and health insurance claims records.
Measured: From baseline up to 5 years
Descriptive summary on the burden of care - psychological dimension
This outcome will be assessed using the Zarit Burden Interview (ZBI), a 22-item questionnaire scored 0-88 (higher scores indicate greater burden).
Measured: From baseline up to 5 years
Descriptive summary on the burden of care - economic dimension
This outcome will be assessed using the Caregiver Indirect and Informal Care Cost Assessment Questionnaire (CIIQ), which includes 13 questions on work status, productivity, and informal care costs.
Measured: From baseline up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start21 Jul 2026
- Primary completion21 Dec 2032 (estimated)
- Study completion1 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330258
- Sponsor's protocol ID
- 23021
- Status last verified
- Jul 2026
- First submitted
- 9 Dec 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Natural History Study of Treated Parkinson's Disease Patients Experiencing Motor Complications
- ClinicalTrials.gov ID
- NCT07330258
- Acronym / sponsor ID
- 23021
- Conditions
- Parkinson's Disease
- Keywords
- Natural history study, Parkinson's disease, PD Motor (Hauser) Diary, MDS-UPDRS, Electronic health/medical records, Administrative claims data, Biological samples, Digital health technology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 21 Dec 2032 (estimated)
- Study completion
- 1 Jun 2033 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease Cohort | – | Other: Standard of CareA single cohort of patients with Parkinson's disease experiencing motor complications while receiving standard-of-care oral therapies. The care partner of the patient may also participate in the study. |
| Care Partners Cohort | – | –The care partner of the patient may also participate in the study. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease experiencing motor complications while on antiparkinsonian medications
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareFollow clinical practice/administration. No investigational products will be administered in this study. Patients will be treated in accordance with standard of care as determined by their clinician. | Other | Parkinson's Disease Cohort |
Primary outcome
Descriptive summary of motor outcomes among Parkinson's disease patients treated with oral antiparkinsonian medications who experience motor complications.
Time frame: From baseline up to 5 years
This outcome will be assessed using Parkinson's disease (PD) Motor (Hauser) Diary, Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II-IV (each part has several items scored from 0-normal to 4-severe; with higher scores indicating greater impairment), modified Hoehn \& Yahr (stages Parkinson's disease severity from 1 [unilateral involvement only] to 5 [wheelchair-bound or bedridden unless aided]), Universal Dyskinesia Rating Scale (UDysRS) (items scored from 0-none to 4-severe; higher scores indicate more severe dyskinesia), medical records, and digital health technology.
Descriptive summary of non-motor outcomes among Parkinson's disease patients treated with oral antiparkinsonian medications who experience motor complications.
Time frame: From baseline up to 5 years
This outcome will be assessed using Montreal Cognitive Assessment (MoCA, score 0-30, higher = better cognition), MDS-UPDRS I (4-point scale, higher = greater impairment), modified Schwab \& England Activities of Daily Living (0-100%, higher = greater independence), MDS Non-Motor Rating Scale (MDS-NMS, 4-point scale, higher = more severe non-motor symptoms), Parkinson's Disease Questionnaire-39 (PDQ-39, 0-100 scale, higher = worse quality of life), Parkinson's Disease Health Index (PD-HI, higher = worse health status), Parkinson's Disease Sleep Scale 2 (PDSS-2, 4-point scale, higher = more severe sleep problems), Clinical Global Impressions Severity (CGI-S, 7-point scale, higher = greater severity of illness), Patient Global Impression Severity (PGI-S, 7-point scale, higher = greater severity), EuroQoL 5-Dimension 5-Level (EQ-5D-5L, 5 dimensions, 5 levels, plus visual analogue scale (VAS) 0-100 [100=best imaginable health]), medical records, and digital health technology.
Descriptive summary of Parkinson's medications and treatments received
Time frame: From baseline up to 5 years
This outcome will be assessed by the logs (Parkinson's medications, Parkinson's advanced therapies, rehabilitation therapies \& mobility assistance devices) completed by the patient, medical records, and health insurance claims records.
Descriptive summary on the burden of care - psychological dimension
Time frame: From baseline up to 5 years
This outcome will be assessed using the Zarit Burden Interview (ZBI), a 22-item questionnaire scored 0-88 (higher scores indicate greater burden).
Descriptive summary on the burden of care - economic dimension
Time frame: From baseline up to 5 years
This outcome will be assessed using the Caregiver Indirect and Informal Care Cost Assessment Questionnaire (CIIQ), which includes 13 questions on work status, productivity, and informal care costs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No. Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Bayer at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive summary of motor outcomes among Parkinson's disease patients treated with oral antiparkinsonian medications who experience motor complications. (time frame: From baseline up to 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.