Real-Time Levodopa Level Monitoring in Parkinson Disease

NCT04735627 | Recruiting FDA Device

• 1 other identifier: 201535
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Levodopa Levels

  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 Outcomes (2)

• Patient Acceptability of Levodopameter

  through study completion, an average of 12 months

• Device Safety

  through study completion, an average of 12 months

Study Arms (1)

Levodopameter

EXPERIMENTAL

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

Interventions

Levodopameter DEVICE

There are several minimally-invasive sensors being developed that can detect levodopa levels in the capillary blood, sweat, and interstitial fluid.

Levodopameter

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet the Movement Disorders Society (MDS) diagnostic criteria for clinically established Parkinson disease.
• Able to provide signed informed consent (in English or Spanish)
• Mild, moderate, or severe Parkinson disease, able to ambulate (Hoehn and Yahr stages I-IV)
• Taking instant release oral carbidopa/levodopa therapy
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San DIego

San Diego, California, 92093, United States

RECRUITING

Related Publications (4)

• Goud KY, Moonla C, Mishra RK, Yu C, Narayan R, Litvan I, Wang J. Wearable Electrochemical Microneedle Sensor for Continuous Monitoring of Levodopa: Toward Parkinson Management. ACS Sens. 2019 Aug 23;4(8):2196-2204. doi: 10.1021/acssensors.9b01127. Epub 2019 Aug 12.

  PMID: 31403773 BACKGROUND

• Brunetti B, Valdés-Ramírez G, Litvan I, Wang J. A disposable electrochemical biosensor for L-DOPA determination in undiluted human serum. Electrochemistry Communications 2014. p. 28-31.

  BACKGROUND

• Bandodkar AJ, Wang J. Non-invasive wearable electrochemical sensors: a review. Trends Biotechnol. 2014 Jul;32(7):363-71. doi: 10.1016/j.tibtech.2014.04.005. Epub 2014 May 19.

  PMID: 24853270 BACKGROUND

• Windmiller JR, Wang J. Wearable electrochemical sensors and biosensors: a review.: Electroanalysis; 2013. p. 29-46.

  BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Irene Litvan, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Skipworth

CONTACT

858-246-2537; mskipworth@health.ucsd.edu

Katherine Longardner, MD

CONTACT

klongardner@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the UCSD Parkinson and Other Movement Disorders Center

Model Details: Participants will receive oral carbidopa and levodopa and the minimally invasive experimental device will measure levodopa levels in capillary blood, sweat, and/or interstitial fluid (separate experiments and consents), which will be compared to plasma levodopa levels measured using high-performance liquid chromotography.

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: February 3, 2021
• Study Start: December 7, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)