Recruiting

Levodopa Monitoring

Sponsor:

UCLA

Code:

NCT04735627

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Levodopameter

Study Details

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

Study ID

NCT04735627

Start date

Dec 7, 2021

Status verified date

Feb, 2025

Completion date

Feb, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Levodopameter

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

Primary outcome measure

  • Levodopa Levels [ Time Frame: through study completion, an average of 12 months ]

Central Contacts and Locations

Central contacts

Michael Skipworth

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

Katherine Longardner, MD

klongardner@health.ucsd.edu

Locations

University of California San DIego

Recruiting

San Diego, California, United States, 92093

Contacts

Hamid Ghodsi, MD

hghodsi@health.ucsd.edu

Alonzo Mendoza, BS

alm012@health.ucsd.edu

Principal Investigator:

Irene Litvan, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Feb 11, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-02-11.