NCT04735627 Real-Time Levodopa Level Monitoring in Parkinson Disease
| NCT ID | NCT04735627 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-12-07 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2021-12-07 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Irene Litvan, MD
PRINCIPAL INVESTIGATOR
UCSD
Frequently Asked Questions
Who can join the NCT04735627 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04735627 currently recruiting?
Yes, NCT04735627 is actively recruiting participants. Contact the research team at mskipworth@health.ucsd.edu for enrollment information.
Where is the NCT04735627 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT04735627 clinical trial?
NCT04735627 is sponsored by University of California, San Diego. The principal investigator is Irene Litvan, MD at UCSD. The trial plans to enroll 20 participants.
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