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Levodopa Monitoring Device for Parkinson's Disease

N/A

Recruiting

Led By Irene Litvan, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mild, moderate, or severe Parkinson disease, able to ambulate (Hoehn and Yahr stages I-IV)

Taking instant release oral carbidopa/levodopa therapy

Must not have

Uncontrolled, active medical conditions (e.g., heart, kidney, or liver failure, diabetes, etc.)

Other neurological conditions including but not limited to stroke, dementia (including Parkinson disease dementia), or traumatic brain injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trialwill use a tiny sensor to monitor Parkinson's medication levels in real-time, testing its accuracy, safety, and comfort.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects are not specified here, potential risks might include skin irritation or discomfort at the sensor site due to the minimally invasive nature of the microneedle device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Parkinson's disease and can walk.

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I am currently taking oral carbidopa/levodopa medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled, serious health conditions.

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I have a neurological condition like stroke, dementia, or brain injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Levodopa Levels

Secondary study objectives

Device Safety

Patient Acceptability of Levodopameter

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LevodopameterExperimental Treatment1 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.

0 / 4Eligibility criteria met