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NCT04821830 · ClinicalTrials.gov registry record · Phase 4
Vigor and the LDR in Parkinson Disease
A Phase 4 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 19
- Enrollment target
NCT04821830: Completed Phase 4 study, sponsored by University of Michigan.
NCT04821830 is a Phase 4 study that has completed, run by University of Michigan. The registered enrollment target is 19 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04821830, a Phase 4 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 19 participants
- Enrollment target
Study Summary
Parkinson disease (PD) is a common disorder in which reduced speed of movement results from inadequate brain production of the chemical dopamine. The most effective treatment for PD is the drug levo-dopa, which partially replaces brain dopamine. Despite decades of successful use, how levo-dopa improves speed of movement in PD is not understood. This observational study recruits participants who have been prescribed levo-dopa by their treating physicians. Before their first dose, immediately after their first dose and later, when their dose has been stabilized, they will engage with the research team to participate in a few simple experiments to measure speed, grip strength, tremor, and stability (on and off of treatment). The purpose of these experiments is to understand how levo-dopa treatment in Parkinson disease enhances movement speed. An important but not understood component of levo-dopa action, the Long Duration Response (LDR), lasts for days to weeks. A basic function of dopamine signaling in the brain is modulation of motivation - the coupling between effort and action values. These experiments will determine if the LDR is associated with relative normalization of motivation function in the brain. The motivation behavior of recently diagnosed PD participants will be examined before and after treatment with levo-dopa to determine if the magnitude of the LDR is correlated with improvements in motivation behavior.
Primary Outcome
Measurement of bradykinesia. With the hand most affected by PD, participants were instructed to alternately tap 2 manual counters spaced 20 cm apart as rapidly as possible for 1 minute. The longer participants took to complete the task indicated a higher degree of bradykinesia affecting them. This task was administered over the course of 4 visits during the following conditions: Visit 1. Baseline prior to chronic treatment initiation (Treatment Naïve Subject); Visit 2. After the initial, standa
Interventions
- DRUG carbidopa/levodopa, as prescribed by treating physician
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-02-12 |
| Est. Completion | 2024-04-25 |
| Phase | Phase 4 |
What the finished NCT04821830 record still lists
NCT04821830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which carbidopa/levodopa, as prescribed by treating physician is the first listed.
NCT04821830 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04821830 about?
NCT04821830 is a clinical study titled "Vigor and the LDR in Parkinson Disease". Parkinson disease (PD) is a common disorder in which reduced speed of movement results from inadequate brain production of the chemical dopamine. The most effective treatment for PD is the drug levo-dopa, which partially replaces brain dopamine. Despite decades of successful use, how levo-dopa impro...
What is the current status of trial NCT04821830?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 19 participants. The study started on 2020-02-12. Estimated completion is 2024-04-25.
What interventions are being tested in trial NCT04821830?
The interventions under investigation include: carbidopa/levodopa, as prescribed by treating physician (DRUG).
Who is sponsoring clinical trial NCT04821830?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04821830's enrollment target sits among peer trials
19 1834th of 2000 higher than 159 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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