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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

Recruiting
Not specifiedAges 45–75Observational
Bayer
~300 participants
Updated 2026-09-04 on ClinicalTrials.gov
What's tested:Standard of Care

At a glance

Recruiting sites
7 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Descriptive summary of motor outcomes among Parkinson's disease patients treated with oral antiparkinsonian medications who experience motor complications.
Measured over From baseline up to 5 years
+4 more outcomes measured

Conditions

Parkinson's Disease

NCT07330258

Where you'd take part

This study runs at 27 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AdventHealth Neuroscience Institute

    Orlando, Floridano site contact published

    Not yet recruiting

  • Banner Alzheimer's Institute (BAI)-Phoenix

    Phoenix, Arizonano site contact published

    Recruiting

  • Baptist Health Miami Neuroscience Institute

    Miami, Floridano site contact published

    Recruiting

  • Baylor College of Medicine

    Houston, Texasno site contact published

    Not yet recruiting

  • Boston Medical Center

    Boston, Massachusettsno site contact published

    Not yet recruiting

  • Cleveland Clinic

    Cleveland, Ohiono site contact published

    Not yet recruiting

  • Intermountain Health

    Murray, Utahno site contact published

    Not yet recruiting

  • Keck School of Medicine

    Los Angeles, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Bayer Clinical Trials Contact
[email protected]
(+)1-888-84 22937
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
≥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

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.
Not applicable.

What this trial measures

  • Descriptive summary of motor outcomes among Parkinson's disease patients treated with oral antiparkinsonian medications who experience motor complications.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.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 receivedFrom 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 dimensionFrom 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 dimensionFrom 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.