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

Trial Summary

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 data supports the effectiveness of the drug Sinemet CR for Parkinson's disease?

Research shows that Sinemet CR, a slow-release form of levodopa, helps improve motor function and reduces the number of 'off' periods (times when medication effects wear off) in people with Parkinson's disease. Patients reported better overall motor function and preferred Sinemet CR over standard levodopa, despite some experiencing delayed onset of effects. ^{1 2 3 4 5}

Is the Levodopa Monitoring Device generally safe for humans?

The studies on Sinemet CR, a form of levodopa, show that it is generally safe for humans, with most side effects being mild or moderate. In one study, only 10% of patients stopped using it due to side effects, and no unexpected side effects were observed in another study. ^{1 3 4 6 7}

How does the drug Levodopa Monitoring Device differ from other Parkinson's disease treatments?

The Levodopa Monitoring Device is unique because it involves a controlled-release formulation of levodopa and carbidopa, which provides a prolonged effect by gradually dissolving in the small intestine. This approach helps reduce the number of 'off' periods and increases the time patients experience symptom relief, compared to standard formulations that require more frequent dosing. ^{2 3 4 7 8}

What is the purpose of this trial?

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.

Research Team

Irene Litvan, MD

Principal Investigator

UCSD

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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 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]

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]

References

1. Germany 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. [2019]

2. England 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. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Trial of Sinemet CR4 in patients with Parkinson's disease. [2013]

4. Netherlands 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Long-term evaluation of Sinemet CR in parkinsonian patients with motor fluctuations. [2019]

7. Germany 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. [2019]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The use of the Sinemet-CR preparation in treating Parkinson's disease]. [2016]