Real-Time Levodopa Level Monitoring in 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.
Conditions:
🦠 Parkinson Disease
🗓️ Study Start (Actual) 7 December 2021
🗓️ Primary Completion (Estimated) December 2027
✅ Study Completion (Estimated) February 2028
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 San Diego, California, United States

📋 Eligibility Criteria

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.
Ages Eligible for Study: 40 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 19 September 2020
  • First Submitted that Met QC Criteria 28 January 2021
  • First Posted 3 February 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 January 2024
  • Last Update Posted 1 February 2024
  • Last Verified January 2024