Real-Time Levodopa Level Monitoring in Parkinson Disease

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT04735627
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 7, 2021
Status verified
Feb 2025
Primary completion
Dec 31, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DIegoSan DiegoCalifornia92093
Hamid Ghodsi, MD
Alonzo Mendoza, BS
Irene Litvan, MD (PRINCIPAL_INVESTIGATOR)
Joseph Wang, PhD (PRINCIPAL_INVESTIGATOR)
Katherine Longardner, MD (SUB_INVESTIGATOR)

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