Trial · NCT05487300
Effect of Levodopa on Cardiovascular Autonomic Function in Parkinson's Disease
NCT05487300, Phase 2, Phase 3, Completed, University of Utah; results first posted 2024-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Levodopa on Cardiovascular Autonomic Function in Parkinson's Disease. Trials, record NCT05487300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05487300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Levodopa on Cardiovascular Autonomic Function in Parkinson's Disease
- NCT number
- NCT05487300
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 40 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Parkinson Disease, Orthostatic Hypotension
- Interventions
- Autonomic testing on and off levodopa
- First posted
- 2022-08-04
- Last updated
- 2024-12-05
- Results first posted
- 2024-12-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Systolic Blood Pressure From Supine to Tilt at 3 Minutes | from supine (baseline) to tilt at 3 minutes | Change in systolic blood pressure from supine to tilt at 3 minutes |
| Secondary | Baroreflex Cardiovagal Function | Measure during Valsalva maneuver during autonomic testing (on levodopa and off levodopa) | Index of cardiovagal function: cardiovagal baroreflex sensitivity (BRS-V) \[lower scores = worse outcome\]. The BRS-V is the slope of the relationship between cardiac R-R interval and blood pressure in phase II of the Valsalva maneuver |
| Secondary | Baroreflex Adrenergic Sensitivity | BRS-A was calculated during the Valsalva maneuver (on and off levodopa) | Baroreflex adrenergic sensitivity (BRS-A) in mmHg/s \[lower scores = worse outcome\]. The BRS-A was calculated as the systolic blood pressure decrement associated with phase 3 of the Valsalva maneuver divided by the blood pressure recovery time |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Systolic Blood Pressure From Supine to Tilt at 3 Minutes | from supine (baseline) to tilt at 3 minutes | The results are presented ON vs OFF levodopa | mmHg | MEAN |
| SECONDARY | Baroreflex Cardiovagal Function | Measure during Valsalva maneuver during autonomic testing (on levodopa and off levodopa) | BRS-V - Results ON vs OFF levodopa | ms/mmHg | MEAN |
| SECONDARY | Baroreflex Adrenergic Sensitivity | BRS-A was calculated during the Valsalva maneuver (on and off levodopa) | BRS-A - ON vs OFF levodopa | mmHg/s | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Systolic Blood Pressure From Supine to Tilt at 3 Minutes | Testing ON Levodopa | -24.22 | Standard Deviation 17.69 | mmHg | |
| Change in Systolic Blood Pressure From Supine to Tilt at 3 Minutes | Testing Off Levodopa | -20.32 | Standard Deviation 19.88 | mmHg | |
| Baroreflex Cardiovagal Function | Testing On-levodopa | 2.49 | Standard Deviation 2.39 | ms/mmHg | |
| Baroreflex Cardiovagal Function | Testing Off-levodopa | 2.02 | Standard Deviation 2.16 | ms/mmHg | |
| Baroreflex Adrenergic Sensitivity | Testing ON Levodopa | 5.29 | Standard Deviation 6.51 | mmHg/s | |
| Baroreflex Adrenergic Sensitivity | Testing Off Levodopa | 6.88 | Standard Deviation 6.73 | mmHg/s |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Testing On-levodopa First, Then Off-levodopa | 20 | |
| Overall Study | STARTED | Testing Off-levodopa, Then On-levodopa | 20 | |
| Overall Study | COMPLETED | Testing On-levodopa First, Then Off-levodopa | 19 | |
| Overall Study | COMPLETED | Testing Off-levodopa, Then On-levodopa | 20 | |
| Overall Study | NOT COMPLETED | Testing On-levodopa First, Then Off-levodopa | 1 | |
| Overall Study | NOT COMPLETED | Testing Off-levodopa, Then On-levodopa | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Testing On-levodopa | 0 | 38 |
| Total, all-cause mortality | Testing Off-levodopa | 0 | 38 |
| Total, other adverse events | Testing On-levodopa | 0 | 38 |
| Total, other adverse events | Testing Off-levodopa | 0 | 38 |
| Total, serious adverse events | Testing On-levodopa | 0 | 38 |
| Total, serious adverse events | Testing Off-levodopa | 0 | 38 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Testing On-levodopa vs Testing Off-levodopa: deaths from any cause | Trial comparisons |
| Testing On-levodopa vs Testing Off-levodopa: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05487300
GET https://conductscience.org/api/trials/v1/NCT05487300/registered