How Parkinson's changes over time in people whose movement symptoms persist despite medication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational natural-history project enrolling people with clinically established Parkinson's disease who continue to have motor symptoms despite standard antiparkinsonian medications. Participants receive usual clinical care while researchers collect clinical measures such as MDS‑UPDRS motor scores, PD motor (Hauser) diaries, and electronic health/medical record data. No experimental treatments are given; data are analyzed to characterize symptom fluctuations, progression, and treatment patterns over time. The study focuses on patients 45–75 years old, within 4–<12 years of diagnosis and with measurable OFF-state motor disability and daily OFF time.

Why it matters

Who can join: the full rules

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.

Where it's running

• Banner Alzheimer's Institute (BAI)-Phoenix
  Phoenix, Arizona, United States Recruiting
• The Parkinson's & Movement Disorder Institute
  Fountain Valley, California, United States Recruiting
• Keck School of Medicine
  Los Angeles, California, United States Recruiting
• Baptist Health Miami Neuroscience Institute
  Miami, Florida, United States Recruiting
• Medical College of Georgia at Augusta University
  Augusta, Georgia, United States Recruiting
• University of Buffalo Jacobs School of Medicine
  Williamsville, New York, United States Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: (+)1-888-84 22937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ginger as a Modifier of Ghrelin Levels in Parkinson’s Disease and REM Sleep Behavior Disorder

  This study tests whether ginger capsules can raise ghrelin levels in people with Parkinson’s disease, REM sleep behavior disorder, and healthy controls.

  Recruiting Cambridge University Hospitals NHS Foundation Trust · Cambridge · NCT07882108

• Intraoperative Microelectrode Recordings with MAVEN vs Standard Equipment

  This study tests whether MAVEN can match the recording data collected during DBS surgery for movement disorders using standard equipment.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07868614

• Mental imagery with self-regulation to help daily activities in Parkinson's disease

  This study tests whether a six-week program of mental imagery combined with self-regulation can help people with Parkinson’s perform daily activities better than standard learning or exercise.

  Recruiting The Hong Kong Polytechnic University · Hong Kong · NCT07860294

• Real-world experiences of Inbrija for Parkinson's OFF episodes

  This study looks at how people with Parkinson’s who use Inbrija for OFF episodes feel and function in daily life.

  Recruiting Merz Pharmaceuticals GmbH · Altmünster and 1 other locations · NCT07797790

• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

  This study tests whether a probiotic containing Limosilactobacillus reuteri can help people with Parkinson's disease, those at high risk for PD, and related cognitive issues by potentially improving gut methane levels and overall symptoms.

  Recruiting University of Cambridge · Cambridge, CB2 · NCT07786116

• Test of RO7568282 in early Parkinson's disease

  This study tests whether RO7568282, compared with placebo, is safe and helps people with early Parkinson's disease who are already taking levodopa.

  Recruiting at 4 sites Phase 2 Hoffmann-La Roche · Boca Raton, Florida and 3 other locations · NCT07781644

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.