Real-Time Levodopa Level Monitoring in Parkinson Disease

January 30, 2024 updated by: Irene Litvan, University of California, San Diego

Real-Time Levodopa Monitoring for Improved Management of Parkinson Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92093
        • Recruiting
        • University of California San Diego
        • Principal Investigator:
          • Irene Litvan, MD
        • Principal Investigator:
          • Joseph Wang, PhD
        • Sub-Investigator:
          • Katherine Longardner, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levodopameter
During the single study visit, participants will receive either: 1) one doses of oral carbidopa/ levodopa. The Levodopameter sensor device will serially measure levodopa levels from either capillary blood, sweat, or interstitial fluid and blood will be simultaneously collected from an intravenous line for high-performance liquid chromotography analysis of plasma levodopa levels.
Device: Levodopameter
There are several minimally-invasive sensors being developed that can detect levodopa levels in the capillary blood, sweat, and interstitial fluid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levodopa Levels
Time Frame: through study completion, an average of 12 months
Data analysis from this first-of-its-kind microneedle levodopa monitoring device is necessarily exploratory and descriptive. We will assess the Levodopameter's feasibility and accuracy by comparing its interstitial fluid levodopa measurements to plasma levodopa levels analyzed by high-performance liquid chromatography.
through study completion, an average of 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Acceptability of Levodopameter
Time Frame: through study completion, an average of 12 months
Participants will rate acceptability of the Levodopameter using a symmetric Likert-style questionnaire ranging from 1 (strongly disagree) to 5 (strongly agree) to rate the device's comfort, ease of wear, and other qualities. Averaged acceptability ratings of 4 and higher (agree or strongly agree) would indicate the participant's agreement on the device acceptability.
through study completion, an average of 12 months
Device Safety
Time Frame: through study completion, an average of 12 months
The investigators will monitor for and categorize the adverse events related to the device using the will be classified using the current version of the Common Terminology Criteria for Adverse Events.
through study completion, an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Irene Litvan, MD, UCSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2021

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

September 19, 2020

First Submitted That Met QC Criteria

January 28, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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