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Testing a sensor that tracks levodopa levels

Researchers test the accuracy, comfort and safety of a sensor designed to measure levodopa levels in real time in people with Parkinson’s.

Testing a treatment or activity · Study reference: NCT04735627

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Looking for volunteers

Start (reported actual date)
2021-12-07
Main measurements finished (planned)
2027-12
Study finished (planned)
2028-02

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

Acute Pharmacodynamic Effects of Oral Levodopa on Blood Pressure in Parkinson's Disease.
Listed by the registry as research derived from the study · 2025

Who can join?

Ages 40 years to 85 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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.
Full study name & original research details

Official study title

Real-Time Levodopa Monitoring for Improved Management of Parkinson Disease

Short title used by the registry

Real-Time Levodopa Level Monitoring in Parkinson Disease

Original description

This project aims to develop a minimally invasive sensor device to monitor levodopa levels in real time. We will test the accuracy, tolerability, and safety of this device in people with Parkinson disease.

Further description from the registry

People with Parkinson disease (PD) lack the chemical dopamine, which is important for movement. Levodopa replaces dopamine and restores normal motor function in PD. Early in the disease stages, people with PD benefit significantly from levodopa. However, as PD progresses, the brain loses more dopamine-producing cells, which causes motor complications and unpredictable responses to levodopa. To maintain control of symptoms over time, levodopa doses must be increased and given at increasingly shorter intervals. The optimal levodopa regimen is different for each person and may vary from day-to-day, depending on a variety of internal and external factors including meal consumption, activity level, and other lifestyle variances. Currently, clinicians assess levodopa's benefit by the patient's testimony and by clinical exam. However, these methods may not adequately represent the severity or range of complications experienced by the PD patient. Thus, it can be difficult to determine the optimal levodopa treatment regimen, which can cause suboptimal disease management and side effects. This project aims to develop a continuous, minimally invasive sensor (the "Levodopameter") designed to measure levodopa levels in real time from body fluids (capillary blood, sweat, and interstitial fluid), with the future goals of identifying an individualized treatment regimen for people with PD to improve disease management. We will compare levodopa levels measured by the Levodopameter to the impractical and expensive "gold standard" high-performance liquid chromatography (HPLC) analysis of plasma levodopa levels. We will first test the device after administering oral carbidopa/levodopa in 10 participants with PD. After that portion of the study is completed and safety confirmed, we will test the device in 10 participants with PD after administering carbidopa and intravenous levodopa. We will also evaluate the device's safety and tolerability. The long-term goal of this device is to allow PD patients to take proactive measures to assess and maintain an optimal, personalized levodopa regimen, similar to diabetes care in which diabetic patients periodically self-monitor their glucose and adjust their insulin regimen accordingly.

Conditions reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Levodopameter
Phases
NA
Sponsor
University of California, San Diego
Start date reported by registry
2021-12-07 (actual)

Registry updated: 2025-02-11 · Status last verified by the registry submitter: 2025-02

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Michael Skipworth · 858-246-2537 · mskipworth@health.ucsd.edu

Katherine Longardner, MD · klongardner@health.ucsd.edu

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

University of California San DIego

San Diego, California, United States

Recruiting

Hamid Ghodsi, MD · hghodsi@health.ucsd.edu

Alonzo Mendoza, BS · alm012@health.ucsd.edu

Irene Litvan, MD

Joseph Wang, PhD

Katherine Longardner, MD

Facility not reported

United States

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.