Monitoring levodopa levels in Parkinson's disease using a new sensor

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 project focuses on developing a minimally invasive sensor device, known as the Levodopameter, to monitor levodopa levels in real time for individuals with Parkinson disease. The study aims to assess the accuracy, tolerability, and safety of this device, which measures levodopa levels from body fluids such as capillary blood, sweat, and interstitial fluid. By providing continuous monitoring, the goal is to identify individualized treatment regimens that can improve disease management and reduce motor complications associated with fluctuating levodopa responses. This approach seeks to enhance the understanding of how levodopa affects patients on a day-to-day basis, potentially leading to better therapeutic outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants must meet the Movement Disorders Society (MDS) diagnostic criteria for clinically established Parkinson disease.
2. Able to provide signed informed consent (in English or Spanish)
3. Mild, moderate, or severe Parkinson disease, able to ambulate (Hoehn and Yahr stages I-IV)
4. Taking instant release oral carbidopa/levodopa therapy
5. Either not taking, or on stable doses of any of the following antiparkinsonian medications: dopamine agonists, monoamine oxidase B (MAO-B) inhibitors or catecholamine O-methyl transferase (COMT) inhibitors

Exclusion Criteria:

1. Other neurological conditions including but not limited to stroke, dementia (including Parkinson disease dementia), or traumatic brain injury
2. Co-existent major psychiatric disease
3. Uncontrolled, active medical conditions (e.g., heart, kidney, or liver failure, diabetes, etc.)
4. Status post deep brain stimulation (DBS) device placement
5. Any other condition, that in the opinion of the investigators, would place the participant at risk.

Where it's running

• University of California San DIego
  San Diego, California, United States Recruiting

Study contacts

• Principal investigator: Irene Litvan, MD — UCSD
• Study coordinator: Michael Skipworth
• Email: mskipworth@health.ucsd.edu
• Phone: 858-246-2537

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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.