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NCT05487300 · ClinicalTrials.gov registry record · Phase 2

Effect of Levodopa on Cardiovascular Autonomic Function in Parkinson's Disease

A Phase 2 study, sponsored by University of Utah.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT05487300 is a Phase 2 study that has completed, run by University of Utah. The registered enrollment target is 40 participants.

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The verdict

NCT05487300, a Phase 2 study, has completed, sponsored by University of Utah.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

Levodopa is a precursor of dopamine and is the treatment of choice to treat the motor symptoms of Parkinson's disease (PD); however, the effect of levodopa on cardiovascular autonomic function in PD is poorly understood. Orthostatic hypotension has been documented as a potential side effect of levodopa. As a result, clinicians may be reluctant to prescribe levodopa in patients with PD with neurogenic orthostatic hypotension (PD+OH), which leads to suboptimal management of motor symptoms. On the other hand, other studies failed to show any clear relationship between levodopa and orthostatic hypotension in patients with PD. Important limitations of prior studies include the lack of detailed investigation of baroreflex cardiovagal and sympathetic noradrenergic functions and the fact that the same patients were not tested on and off levodopa. The investigators propose to investigate the effects of levodopa on cardiovascular autonomic function in patients with PD+OH and PD without neurogenic orthostatic hypotension (PD-OH) by performing standardized autonomic testing in the same patients on and off levodopa.

Interventions

  • DRUG Autonomic testing on and off levodopa

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2022-05-11
Est. Completion 2023-05-01
Phase Phase 2

Sponsor

University of Utah

818 total trials

What the Registry Record Tells You About NCT05487300

The ClinicalTrials.gov registry entry for NCT05487300 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Autonomic testing on and off levodopa is the first listed.

NCT05487300 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05487300 about?

NCT05487300 is a clinical study titled "Effect of Levodopa on Cardiovascular Autonomic Function in Parkinson's Disease". Levodopa is a precursor of dopamine and is the treatment of choice to treat the motor symptoms of Parkinson's disease (PD); however, the effect of levodopa on cardiovascular autonomic function in PD is poorly understood. Orthostatic hypotension has been documented as a potential side effect of levod...

What is the current status of trial NCT05487300?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-05-11. Estimated completion is 2023-05-01.

What interventions are being tested in trial NCT05487300?

The interventions under investigation include: Autonomic testing on and off levodopa (DRUG).

Who is sponsoring clinical trial NCT05487300?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.