Levodopa Monitoring Device for Parkinson's Disease

Overseen By Katherine Longardner, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must be taking: Carbidopa/Levodopa

Disqualifiers: Stroke, Dementia, Major psychiatric disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Single visit

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device designed to monitor levodopa levels in people with Parkinson's disease. Levodopa is a key medication for managing symptoms, and the device, called the Levodopameter, tracks its levels in real time using a small sensor. Participants will use the device while taking their regular medication to determine if it accurately measures the drug level in their system. It suits those with Parkinson's who can walk and currently use carbidopa/levodopa medication. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily management of Parkinson's symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on a stable dose of certain Parkinson's medications like dopamine agonists, MAO-B inhibitors, or COMT inhibitors.

What prior data suggests that this device is safe for monitoring levodopa levels in people with Parkinson's disease?

Studies have shown that fiber-based sensors can safely track levodopa levels in people with Parkinson's disease. Designed for continuous wear, these sensors are minimally invasive and do not penetrate deeply into the skin. Research indicates that they can effectively measure levodopa levels using a small blood sample from a simple fingerstick. This method aims to be comfortable and easy for users.

Although specific data on side effects related to the Levodopameter device is not available, similar devices used in Parkinson's have generally been well-tolerated. These devices provide real-time information without causing discomfort. Overall, current findings suggest that the device should be safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Levodopameter because it offers a new way to monitor levodopa levels in Parkinson's disease patients. Unlike the standard blood tests that require drawing blood from a vein, the Levodopameter uses a sensor to measure levodopa levels non-invasively from capillary blood, sweat, or interstitial fluid. This could make monitoring more comfortable and accessible for patients, providing real-time data that helps tailor treatment to individual needs more effectively.

What evidence suggests that this device is effective for monitoring levodopa levels in Parkinson's disease?

Research has shown that tracking levodopa levels in real time can help manage Parkinson's disease symptoms. In this trial, participants will use the Levodopameter, a new smart sensor made from special fibers, to continuously monitor these levels. Early studies suggest these sensors accurately measure levodopa in body fluids like sweat or blood. This technology aims to provide precise, real-time information that could improve the management of Parkinson's symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Irene Litvan, MD

Principal Investigator

UCSD

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's disease who can walk and are taking standard carbidopa/levodopa therapy. They must be diagnosed according to MDS criteria, able to consent, and may also be on stable doses of certain other Parkinson's medications. Those with other neurological conditions, major psychiatric diseases, uncontrolled medical issues or brain stimulation devices cannot participate.

Inclusion Criteria

I am not on, or have stable doses of, specific Parkinson's disease medications.

I have Parkinson's disease and can walk.

I am currently taking oral carbidopa/levodopa medication.

Exclusion Criteria

You have a serious mental illness.

Any other condition, that in the opinion of the investigators, would place the participant at risk

I do not have any uncontrolled, serious health conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral carbidopa/levodopa and the Levodopameter device is used to measure levodopa levels

Single visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Levodopameter

Trial Overview The study is testing a new microneedle sensor called Levodopameter designed to monitor levodopa levels in real-time for accuracy and safety in individuals with Parkinson’s disease at various stages of severity.

How Is the Trial Designed?

Group I: Levodopameter Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

In a 12-month study involving 45 patients with Parkinson's disease, Sinemet CR4, a slow-release levodopa preparation, was found to be at least as effective as standard Sinemet, with a significant reduction in tremor and rigidity.

Patients taking Sinemet CR4 required a higher total daily dosage compared to standard Sinemet but had fewer doses per day, indicating improved convenience for managing motor fluctuations without serious adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of Sinemet CR4 in patients with Parkinson's disease. Anderson, TJ., Ewer, TC., Gilchrist, NL., et al.[2013]

In a three-year open-label trial with 18 patients, Sinemet CR (carbidopa/levodopa) showed no significant change in daily dosing frequency, indicating stable long-term management of Parkinson's symptoms.

While patients experienced stable 'on' time, there was an increase in 'on with dyskinesias' over the study period, but no serious side effects or adverse laboratory results were linked to the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term evaluation of Sinemet CR in parkinsonian patients with motor fluctuations. Hutton, JT., Morris, JL.[2019]

In a six-month study involving 17 patients with severe Parkinson's disease, controlled-release levodopa-carbidopa (Sinemet CR-4) showed significant clinical benefits, including improved disability and reduced 'off' periods, compared to standard levodopa/carbidopa.

While the systemic bioavailability of CR-4 was higher, it had a delayed onset of action, leading to the need for additional standard levodopa in some patients to manage symptoms effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and pharmacokinetic evaluation of controlled-release levodopa/carbidopa (CR-4) in parkinsonian patients with severe motor fluctuations: a six month follow-up study. Deleu, D., Jacques, M., Michotte, Y., et al.[2019]

In a study involving 29 patients with Parkinson's disease, Sinemet-CR demonstrated a high effectiveness rate of 80%, particularly improving symptoms like rigidity, hypokinesia, and tremor over a treatment duration of 3 months.

The treatment was found to be safe, with only 6 cases reporting negative side effects, supporting its recommendation for broader use in managing Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of the Sinemet-CR preparation in treating Parkinson's disease]. Artem'ev, DV., Damulin, IV., Iakhno, NN.[2016]

In a study involving 14 Parkinson's patients, controlled-release levodopa/carbidopa (Sinemet CR4) significantly improved the duration of 'on' time and reduced the number of daily doses compared to standard Sinemet, indicating better management of symptoms.

Despite some challenges like delayed onset of effects and increased dyskinesia later in the day, Sinemet CR4 provided equal or better overall motor function, suggesting it could be a beneficial treatment option for Parkinson's patients with fluctuating responses to medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind crossover comparison of Sinemet CR4 and standard Sinemet 25/100 in patients with Parkinson's disease and fluctuating motor performance. Cedarbaum, JM., Hoey, M., McDowell, FH.[2022]

In a study of 450 Parkinson's disease patients, switching from standard levodopa to Sinemet CR led to significant improvements in motor function and daily living activities, especially in those with motor complications.

The treatment was generally well-tolerated, with only 10% of patients discontinuing due to side effects, and a majority of patients preferred Sinemet CR over their previous treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life in patients with Parkinson's disease who transfer from standard levodopa to Sinemet CR: the STAR Study. The STAR Multicenter Study Group. Grandas, F., Martínez-Martín, P., Linazasoro, G.[2019]

In a clinical trial with 170 patients, controlled-release Sinemet (Sinemet CR) significantly reduced 'off' periods and improved overall neurological function compared to standard Sinemet (Sinemet STD) over a 24-week treatment period.

Both Sinemet CR and STD had similar safety profiles, with only one serious drug-related adverse event reported, indicating that Sinemet CR is a safe and effective alternative for managing fluctuating Parkinson's disease symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International (NL-UK) double-blind study of Sinemet CR and standard Sinemet (25/100) in 170 patients with fluctuating Parkinson's disease. Wolters, EC., Tesselaar, HJ.[2019]

Sinemet CR, a sustained-release formulation of levodopa and carbidopa, provides a longer duration of effect compared to conventional Sinemet, allowing for fewer daily doses in parkinsonian patients.

In an 8-week trial with 25 patients, those using Sinemet CR experienced improved 'on' times, suggesting that combining both Sinemet formulations may optimize treatment for better management of Parkinson's symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical studies with and pharmacokinetic considerations of sustained-release levodopa. LeWitt, PA.[2013]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39021200/

a systematic review and cost-effectiveness analysis Objectives: To determine the clinical and cost-effectiveness of five devices for monitoring Parkinson's disease: Personal KinetiGraph, Kinesia 360, KinesiaU, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04735627

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 ...

3. nature.com nature.com/articles/s41598-023-48209-y

Home-based monitoring of persons with advanced ... 21 advanced PD patients with motor fluctuations were monitored for 2 weeks using a SW and a smartphone-dedicated app (Intel Pharma Analytics Platform).

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748013224004699

Intelligent fiber-based sensors for continuous monitoring of ... Fiber-based biochemical and biomechanical sensors have been engineered for continuous monitoring of levodopa levels and motor symptoms.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11700807/

Commercial symptom monitoring devices in Parkinson's ... Feetme™ has demonstrated to provide good results in tests such as the 6 min walk test (65). However, in the field of Parkinson's Disease, Feetme ...

6. neurology.org neurology.org/doi/10.1212/WNL.0000000000206064

Real-time Levodopa Level Monitoring from Capillary Blood ... We have developed a novel method to measure levodopa levels using capillary fingerstick blood in PD for timely and personalized medication adjustment.

7. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(24)00052-8/abstract

Safety and efficacy of continuous subcutaneous levodopa ... ND0612 might offer a safe and efficacious subcutaneous levodopa infusion approach to managing motor fluctuations in people with Parkinson's ...