RECRUITING

Real-Time Levodopa Level Monitoring in Parkinson Disease

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Conditions

Parkinson Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Real-Time Levodopa Monitoring for Improved Management of Parkinson Disease

Quick Facts

Study Start:2021-12-07
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04735627

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants must meet the Movement Disorders Society (MDS) diagnostic criteria for clinically established Parkinson disease.
  2. 2. Able to provide signed informed consent (in English or Spanish)
  3. 3. Mild, moderate, or severe Parkinson disease, able to ambulate (Hoehn and Yahr stages I-IV)
  4. 4. Taking instant release oral carbidopa/levodopa therapy
  5. 5. 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
  1. 1. Other neurological conditions including but not limited to stroke, dementia (including Parkinson disease dementia), or traumatic brain injury
  2. 2. Co-existent major psychiatric disease
  3. 3. Uncontrolled, active medical conditions (e.g., heart, kidney, or liver failure, diabetes, etc.)
  4. 4. Status post deep brain stimulation (DBS) device placement
  5. 5. Any other condition, that in the opinion of the investigators, would place the participant at risk.

Contacts and Locations

Study Contact

Michael Skipworth
CONTACT
858-246-2537
mskipworth@health.ucsd.edu
Katherine Longardner, MD
CONTACT
klongardner@health.ucsd.edu

Principal Investigator

Irene Litvan, MD
PRINCIPAL_INVESTIGATOR
UCSD

Study Locations (Sites)

University of California San DIego
San Diego, California, 92093
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Irene Litvan, MD, PRINCIPAL_INVESTIGATOR, UCSD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-07
Study Completion Date2028-02

Study Record Updates

Study Start Date2021-12-07
Study Completion Date2028-02

Terms related to this study

Additional Relevant MeSH Terms

  • Parkinson Disease