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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have Parkinson's disease and can walk.
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I am currently taking oral carbidopa/levodopa medication.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Levodopa Levels
Secondary outcome measures
Device Safety
Patient Acceptability of Levodopameter

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.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,387 Total Patients Enrolled
Irene Litvan, MDPrincipal InvestigatorUCSD
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Parkinson's Disease Research Study Groups: Levodopameter
Parkinson's Disease Clinical Trial 2023: Levodopameter Highlights & Side Effects. Trial Name: NCT04735627 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for me to partake in this trial?

"The study is looking for around 20 qualified individuals with a diagnosis of Parkinson's disease. Prospective participants must also be between the ages of 40 and 85 to be eligible."

Answered by AI

Does this investigation welcome elderly persons to participate?

"The age range for eligibility in this clinical trial extends from 40 to 85 years."

Answered by AI

What is the current participant count for this research effort?

"Correct. Clinicaltrials.gov confirms that this medical study, initially posted on December 7th 2021 is currently looking for participants. About 20 persons need to be sourced from 1 facility."

Answered by AI

Does this research endeavor still accept participants?

"This particular medical research project, which was initially posted on the 7th December 2021, is currently recruiting participants. The listing has been modified most recently on November 1st 2022."

Answered by AI

Who else is applying?

What site did they apply to?
University of California San DIego
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Real-Time Levodopa Level Monitoring in Parkinson Disease
Irene Litvan 2021. "Real-Time Levodopa Level Monitoring in Parkinson Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04735627.
All > Parkinsons Disease > Parkinson Disease
~12 spots leftby Dec 2027
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