Trial Outcomes & Findings for Effect of Levodopa on Cardiovascular Autonomic Function in Parkinson's Disease (NCT NCT05487300)
NCT ID: NCT05487300
Last Updated: 2024-12-05
Results Overview
Change in systolic blood pressure from supine to tilt at 3 minutes
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
40 participants
Primary outcome timeframe
from supine (baseline) to tilt at 3 minutes
Results posted on
2024-12-05
Participant Flow
Forty individuals with PD (21 PD with orthostatic hypotension, 19 PD without orthostatic hypotension) were prospectively enrolled from August 1, 2022 to March 1, 2023. One subject did not complete visits 2 and 3 because of an unexpected surgery that was unrelated to the study and was excluded from the analysis. Another subject was excluded from the final analysis as a result of possible residual medication effects.
Participant milestones
| Measure |
Testing On-levodopa First, Then Off-levodopa
Participants underwent autonomic testing one hour after taking their regular morning dose of levodopa (ON state). On a separate day, they then underwent autonomic testing after at least 12 hours from the last dose of levodopa (OFF state).
|
Testing Off-levodopa, Then On-levodopa
Participants underwent autonomic testing after at least 12 hours from the last dose of levodopa (OFF state). On a separate day, they then underwent autonomic testing one hour after taking their regular morning dose of levodopa (ON state).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Testing On-levodopa First, Then Off-levodopa
Participants underwent autonomic testing one hour after taking their regular morning dose of levodopa (ON state). On a separate day, they then underwent autonomic testing after at least 12 hours from the last dose of levodopa (OFF state).
|
Testing Off-levodopa, Then On-levodopa
Participants underwent autonomic testing after at least 12 hours from the last dose of levodopa (OFF state). On a separate day, they then underwent autonomic testing one hour after taking their regular morning dose of levodopa (ON state).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Effect of Levodopa on Cardiovascular Autonomic Function in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Testing On-levodopa First, Then Off-levodopa
n=19 Participants
Participants underwent autonomic testing one hour after taking their regular morning dose of levodopa (ON state). On a separate day, they then underwent autonomic testing after at least 12 hours from the last dose of levodopa (OFF state).
|
Testing Off-levodopa, Then On-levodopa
n=20 Participants
Participants underwent autonomic testing after at least 12 hours from the last dose of levodopa (OFF state). On a separate day, they then underwent autonomic testing one hour after taking their regular morning dose of levodopa (ON state).
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 8 • n=5 Participants
|
73 years
STANDARD_DEVIATION 8 • n=7 Participants
|
73 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Duration of disease
|
7.7 years
n=5 Participants
|
7.7 years
n=7 Participants
|
7.7 years
n=5 Participants
|
PRIMARY outcome
Timeframe: from supine (baseline) to tilt at 3 minutesPopulation: The results are presented ON vs OFF levodopa
Change in systolic blood pressure from supine to tilt at 3 minutes
Outcome measures
| Measure |
Testing ON Levodopa
n=38 Participants
Participants underwent autonomic testing one hour after taking their regular morning dose of levodopa (ON state).
|
Testing Off Levodopa
n=38 Participants
Participants underwent autonomic testing after at least 12 hours from the last dose of levodopa (OFF state).
|
|---|---|---|
|
Change in Systolic Blood Pressure From Supine to Tilt at 3 Minutes
|
-24.22 mmHg
Standard Deviation 17.69
|
-20.32 mmHg
Standard Deviation 19.88
|
SECONDARY outcome
Timeframe: Measure during Valsalva maneuver during autonomic testing (on levodopa and off levodopa)Population: BRS-V - Results ON vs 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
Outcome measures
| Measure |
Testing ON Levodopa
n=38 Participants
Participants underwent autonomic testing one hour after taking their regular morning dose of levodopa (ON state).
|
Testing Off Levodopa
n=38 Participants
Participants underwent autonomic testing after at least 12 hours from the last dose of levodopa (OFF state).
|
|---|---|---|
|
Baroreflex Cardiovagal Function
|
2.49 ms/mmHg
Standard Deviation 2.39
|
2.02 ms/mmHg
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: BRS-A was calculated during the Valsalva maneuver (on and off levodopa)Population: BRS-A - ON vs 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
Outcome measures
| Measure |
Testing ON Levodopa
n=38 Participants
Participants underwent autonomic testing one hour after taking their regular morning dose of levodopa (ON state).
|
Testing Off Levodopa
n=38 Participants
Participants underwent autonomic testing after at least 12 hours from the last dose of levodopa (OFF state).
|
|---|---|---|
|
Baroreflex Adrenergic Sensitivity
|
5.29 mmHg/s
Standard Deviation 6.51
|
6.88 mmHg/s
Standard Deviation 6.73
|
Adverse Events
Testing On-levodopa
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Testing Off-levodopa
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place