Parkinson DiseaseNCT04735627
Real-Time Levodopa Level Monitoring in Parkinson Disease
A study testing Levodopameter in people with Parkinson Disease, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Levodopameter
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2021to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet the Movement Disorders Society (MDS) diagnostic criteria for clinically established Parkinson disease.
- Able to provide signed informed consent (in English or Spanish)
- Mild, moderate, or severe Parkinson disease, able to ambulate (Hoehn and Yahr stages I-IV)
- Taking instant release oral carbidopa/levodopa therapy
- 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
Who cannot join
- Other neurological conditions including but not limited to stroke, dementia (including Parkinson disease dementia), or traumatic brain injury
- Co-existent major psychiatric disease
- Uncontrolled, active medical conditions (e.g., heart, kidney, or liver failure, diabetes, etc.)
- Status post deep brain stimulation (DBS) device placement
- Any other condition, that in the opinion of the investigators, would place the participant at risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katherine Longardner, MD contact
United States1 site, 1 recruiting
- Recruiting
University of California San DIego
San Diego, California, 92093
Hamid Ghodsi, MD, hghodsi@health.ucsd.edu
Alonzo Mendoza, BS, alm012@health.ucsd.edu
About this study
Official title: Real-Time Levodopa Monitoring for Improved Management of 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.
Read the detailed description
People with Parkinson disease (PD) lack the chemical dopamine, which is important for movement. Levodopa replaces dopamine and restores normal motor function in PD. Early in the disease stages, people with PD benefit significantly from levodopa. However, as PD progresses, the brain loses more dopamine-producing cells, which causes motor complications and unpredictable responses to levodopa. To maintain control of symptoms over time, levodopa doses must be increased and given at increasingly shorter intervals. The optimal levodopa regimen is different for each person and may vary from day-to-day, depending on a variety of internal and external factors including meal consumption, activity level, and other lifestyle variances. Currently, clinicians assess levodopa's benefit by the patient's testimony and by clinical exam. However, these methods may not adequately represent the severity or range of complications experienced by the PD patient. Thus, it can be difficult to determine the optimal levodopa treatment regimen, which can cause suboptimal disease management and side effects.
This project aims to develop a continuous, minimally invasive sensor (the "Levodopameter") designed to measure levodopa levels in real time from body fluids (capillary blood, sweat, and interstitial fluid), with the future goals of identifying an individualized treatment regimen for people with PD to improve disease management.
We will compare levodopa levels measured by the Levodopameter to the impractical and expensive "gold standard" high-performance liquid chromatography (HPLC) analysis of plasma levodopa levels. We will first test the device after administering oral carbidopa/levodopa in 10 participants with PD. After that portion of the study is completed and safety confirmed, we will test the device in 10 participants with PD after administering carbidopa and intravenous levodopa. We will also evaluate the device's safety and tolerability.
The long-term goal of this device is to allow PD patients to take proactive measures to assess and maintain an optimal, personalized levodopa regimen, similar to diabetes care in which diabetic patients periodically self-monitor their glucose and adjust their insulin regimen accordingly.
- Conditions
- Parkinson Disease
- Being tested
- Levodopameter
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevodopameterDevice
There are several minimally-invasive sensors being developed that can detect levodopa levels in the capillary blood, sweat, and interstitial fluid.
| Study group | Role | What they receive |
|---|---|---|
| Levodopameter | Experimental | 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. Receives: Device: Levodopameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levodopa Levels
Data analysis from this first-of-its-kind microneedle levodopa monitoring device is necessarily exploratory and descriptive. We will assess the Levodopameter's feasibility and accuracy by comparing its interstitial fluid levodopa measurements to plasma levodopa levels analyzed by high-performance liquid chromatography.
Measured: through study completion, an average of 12 months
Secondary outcomes (2)
Patient Acceptability of Levodopameter
Participants will rate acceptability of the Levodopameter using a symmetric Likert-style questionnaire ranging from 1 (strongly disagree) to 5 (strongly agree) to rate the device's comfort, ease of wear, and other qualities. Averaged acceptability ratings of 4 and higher (agree or strongly agree) would indicate the participant's agreement on the device acceptability.
Measured: through study completion, an average of 12 months
Device Safety
The investigators will monitor for and categorize the adverse events related to the device using the will be classified using the current version of the Common Terminology Criteria for Adverse Events.
Measured: through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start7 Dec 2021
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will receive oral carbidopa and levodopa and the minimally invasive experimental device will measure levodopa levels in capillary blood, sweat, and/or interstitial fluid (separate experiments and consents), which will be compared to plasma levodopa levels measured using high-performance liquid chromotography.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Litvan, University of California, San Diego
- Investigators
- Irene Litvan, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735627
- Sponsor's protocol ID
- 201535
- Status last verified
- Feb 2025
- First submitted
- 19 Sep 2020
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Goud KY, Moonla C, Mishra RK, Yu C, Narayan R, Litvan I, Wang J. Wearable Electrochemical Microneedle Sensor for Continuous Monitoring of Levodopa: Toward Parkinson Management. ACS Sens. 2019 Aug 23;4(8):2196-2204. doi: 10.1021/acssensors.9b01127. Epub 2019 Aug 12.
PubMed 31403773Brunetti B, Valdés-Ramírez G, Litvan I, Wang J. A disposable electrochemical biosensor for L-DOPA determination in undiluted human serum. Electrochemistry Communications 2014. p. 28-31.
Bandodkar AJ, Wang J. Non-invasive wearable electrochemical sensors: a review. Trends Biotechnol. 2014 Jul;32(7):363-71. doi: 10.1016/j.tibtech.2014.04.005. Epub 2014 May 19.
PubMed 24853270Windmiller JR, Wang J. Wearable electrochemical sensors and biosensors: a review.: Electroanalysis; 2013. p. 29-46.
Longardner K, Liu C, Momper J, Mahato K, Moonla C, Ghodsi H, Wang J, Litvan I. Acute Pharmacodynamic Effects of Oral Levodopa on Blood Pressure in Parkinson's Disease. Pharmacotherapy. 2025 Nov;45(11):721-728. doi: 10.1002/phar.70066. Epub 2025 Oct 1.
PubMed 41031701
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Levodopa Monitoring for Improved Management of Parkinson Disease
- ClinicalTrials.gov ID
- NCT04735627
- Acronym / sponsor ID
- 201535
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
People with Parkinson disease (PD) lack the chemical dopamine, which is important for movement. Levodopa replaces dopamine and restores normal motor function in PD. Early in the disease stages, people with PD benefit significantly from levodopa. However, as PD progresses, the brain loses more dopamine-producing cells, which causes motor complications and unpredictable responses to levodopa. To maintain control of symptoms over time, levodopa doses must be increased and given at increasingly shorter intervals. The optimal levodopa regimen is different for each person and may vary from day-to-day, depending on a variety of internal and external factors including meal consumption, activity level, and other lifestyle variances. Currently, clinicians assess levodopa's benefit by the patient's testimony and by clinical exam. However, these methods may not adequately represent the severity or range of complications experienced by the PD patient. Thus, it can be difficult to determine the optimal levodopa treatment regimen, which can cause suboptimal disease management and side effects.
This project aims to develop a continuous, minimally invasive sensor (the "Levodopameter") designed to measure levodopa levels in real time from body fluids (capillary blood, sweat, and interstitial fluid), with the future goals of identifying an individualized treatment regimen for people with PD to improve disease management.
We will compare levodopa levels measured by the Levodopameter to the impractical and expensive "gold standard" high-performance liquid chromatography (HPLC) analysis of plasma levodopa levels. We will first test the device after administering oral carbidopa/levodopa in 10 participants with PD. After that portion of the study is completed and safety confirmed, we will test the device in 10 participants with PD after administering carbidopa and intravenous levodopa. We will also evaluate the device's safety and tolerability.
The long-term goal of this device is to allow PD patients to take proactive measures to assess and maintain an optimal, personalized levodopa regimen, similar to diabetes care in which diabetic patients periodically self-monitor their glucose and adjust their insulin regimen accordingly.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will receive oral carbidopa and levodopa and the minimally invasive experimental device will measure levodopa levels in capillary blood, sweat, and/or interstitial fluid (separate experiments and consents), which will be compared to plasma levodopa levels measured using high-performance liquid chromotography.
| Arm | Type | Receives |
|---|---|---|
| Levodopameter | Experimental | Device: LevodopameterDuring 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must meet the Movement Disorders Society (MDS) diagnostic criteria for clinically established Parkinson disease.
- Able to provide signed informed consent (in English or Spanish)
- Mild, moderate, or severe Parkinson disease, able to ambulate (Hoehn and Yahr stages I-IV)
- Taking instant release oral carbidopa/levodopa therapy
- 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
Key exclusion criteria (5 listed)
- Other neurological conditions including but not limited to stroke, dementia (including Parkinson disease dementia), or traumatic brain injury
- Co-existent major psychiatric disease
- Uncontrolled, active medical conditions (e.g., heart, kidney, or liver failure, diabetes, etc.)
- Status post deep brain stimulation (DBS) device placement
- Any other condition, that in the opinion of the investigators, would place the participant at risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevodopameterThere are several minimally-invasive sensors being developed that can detect levodopa levels in the capillary blood, sweat, and interstitial fluid. | Device | Levodopameter |
Primary outcome
Levodopa Levels
Time frame: through study completion, an average of 12 months
Data analysis from this first-of-its-kind microneedle levodopa monitoring device is necessarily exploratory and descriptive. We will assess the Levodopameter's feasibility and accuracy by comparing its interstitial fluid levodopa measurements to plasma levodopa levels analyzed by high-performance liquid chromatography.
2 secondary outcomes
Patient Acceptability of Levodopameter
Time frame: through study completion, an average of 12 months
Device Safety
Time frame: through study completion, an average of 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Background: PubMed 31403773Goud KY, Moonla C, Mishra RK, Yu C, Narayan R, Litvan I, Wang J. Wearable Electrochemical Microneedle Sensor for Continuous Monitoring of Levodopa: Toward Parkinson Management. ACS Sens. 2019 Aug 23;4(8):2196-2204. doi: 10.1021/acssensors.9b01127. Epub 2019 Aug 12.
- BackgroundBrunetti B, Valdés-Ramírez G, Litvan I, Wang J. A disposable electrochemical biosensor for L-DOPA determination in undiluted human serum. Electrochemistry Communications 2014. p. 28-31.
- Background: PubMed 24853270Bandodkar AJ, Wang J. Non-invasive wearable electrochemical sensors: a review. Trends Biotechnol. 2014 Jul;32(7):363-71. doi: 10.1016/j.tibtech.2014.04.005. Epub 2014 May 19.
- BackgroundWindmiller JR, Wang J. Wearable electrochemical sensors and biosensors: a review.: Electroanalysis; 2013. p. 29-46.
- Derived from this study: PubMed 41031701Longardner K, Liu C, Momper J, Mahato K, Moonla C, Ghodsi H, Wang J, Litvan I. Acute Pharmacodynamic Effects of Oral Levodopa on Blood Pressure in Parkinson's Disease. Pharmacotherapy. 2025 Nov;45(11):721-728. doi: 10.1002/phar.70066. Epub 2025 Oct 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Longardner, MD contact
Irene Litvan, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levodopameter in people with Parkinson Disease, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Skipworth (858-246-2537, mskipworth@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levodopa Levels (time frame: through study completion, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735627, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.