Monitoring levodopa levels in Parkinson's disease using a new sensor
Real-Time Levodopa Monitoring for Improved Management of Parkinson Disease
This study is testing a new sensor that can measure levodopa levels in real time for people with Parkinson's disease to help improve their treatment and manage symptoms better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT04735627 on ClinicalTrials.gov |
What this trial studies
This project focuses on developing a minimally invasive sensor device, known as the Levodopameter, to monitor levodopa levels in real time for individuals with Parkinson disease. The study aims to assess the accuracy, tolerability, and safety of this device, which measures levodopa levels from body fluids such as capillary blood, sweat, and interstitial fluid. By providing continuous monitoring, the goal is to identify individualized treatment regimens that can improve disease management and reduce motor complications associated with fluctuating levodopa responses. This approach seeks to enhance the understanding of how levodopa affects patients on a day-to-day basis, potentially leading to better therapeutic outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with clinically established Parkinson disease who are currently taking oral carbidopa/levodopa therapy.
Not a fit: Patients with other neurological conditions, major psychiatric diseases, or those who have undergone deep brain stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective management of Parkinson disease symptoms through optimized levodopa dosing.
How similar studies have performed: While the concept of real-time monitoring of medication levels is innovative, similar approaches in other conditions have shown promise, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Diego, California
- University of California San DIego — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Irene Litvan, MD — UCSD
- Study coordinator: Michael Skipworth
- Email: mskipworth@health.ucsd.edu
- Phone: 858-246-2537
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.