Trial Outcomes & Findings for Preventing Levodopa Induced Dyskinesia in Parkinson's Disease With HMG-CoA Reductase Inhibitors (NCT NCT04064294)
NCT ID: NCT04064294
Last Updated: 2025-04-11
Results Overview
The Unified Dyskinesia Rating Scale (UDysRS) combines patient, caregiver, and treating physician perspectives on both historical (Parts 1 \& 2) and objective (Part 3 \& 4) assessments of dyskinesia and dystonia. The historical portion and the objective ratings are added together to form total score ranging from 0 to 104 with higher scores indicating more severe dyskinesia.
COMPLETED
93 participants
11:00 am
2025-04-11
Participant Flow
Participants were recruited based on physician referral at 2 academic medical centers and 1 Veterans administration hospital between July 2019 and March 2024. The first participant was enrolled on August 2019 and the last participant was enrolled in February 2024.
Of the 93 consented participants, 5 did not meet inclusion criteria. Of the 88 enrolled participants, 8 did not complete the intravenous levodopa day visit - 1 was cancelled and did not want to reschedule due to COVID-19 restrictions, 2 past away in the time between the screen and the day visit, 1 no-showed for the day visit, 2 were lost to follow-up, and 2 indicated that they were too busy to attend a full day visit. 80 participants attended the day visit.
Participant milestones
| Measure |
Statin Before Levodopa
Historical use of a statin BEFORE beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
Statin After Levodopa
Historical use of a statin AFTER beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
No Statin
No historical use of a statin
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
16
|
35
|
|
Overall Study
COMPLETED
|
28
|
16
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Statin Before Levodopa
Historical use of a statin BEFORE beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
Statin After Levodopa
Historical use of a statin AFTER beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
No Statin
No historical use of a statin
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
Preventing Levodopa Induced Dyskinesia in Parkinson's Disease With HMG-CoA Reductase Inhibitors
Baseline characteristics by cohort
| Measure |
Statin Before Levodopa
n=28 Participants
Historical use of a statin BEFORE beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
Statin After Levodopa
n=16 Participants
Historical use of a statin AFTER beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
No Statin
n=35 Participants
No historical use of a statin
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75.1 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
72.0 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
70.6 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
72.5 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Education
|
16.6 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
16.9 years
STANDARD_DEVIATION 3.0 • n=7 Participants
|
16.4 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
16.5 years
STANDARD_DEVIATION 2.8 • n=4 Participants
|
|
Age at Parkinson's Diagnosis
|
66.2 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
|
Duration of Parkinson's Disease
|
8.9 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
12.7 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
9.9 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
10.1 years
STANDARD_DEVIATION 4.0 • n=4 Participants
|
|
Hoehn & Yahr Rating
|
2.8 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 0.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: 11:00 amThe Unified Dyskinesia Rating Scale (UDysRS) combines patient, caregiver, and treating physician perspectives on both historical (Parts 1 \& 2) and objective (Part 3 \& 4) assessments of dyskinesia and dystonia. The historical portion and the objective ratings are added together to form total score ranging from 0 to 104 with higher scores indicating more severe dyskinesia.
Outcome measures
| Measure |
Statin Before Levodopa
n=28 Participants
Historical use of a statin BEFORE beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
Statin After Levodopa
n=16 Participants
Historical use of a statin AFTER beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
No Statin
n=35 Participants
No historical use of a statin
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
|---|---|---|---|
|
Peak Unified Dyskinesia Rating Score (UDysRS)
|
10.9 score on a scale
Standard Deviation 10.5
|
10.8 score on a scale
Standard Deviation 11.1
|
13.2 score on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: 11:00 amThe Unified Dyskinesia Rating Scale (UDysRS) objective (Part 3 \& 4) assessments of dyskinesia and dystonia. The objective ratings are added together to form total score ranging from 0 to 44 with higher scores indicating more severe dyskinesia.
Outcome measures
| Measure |
Statin Before Levodopa
n=28 Participants
Historical use of a statin BEFORE beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
Statin After Levodopa
n=16 Participants
Historical use of a statin AFTER beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
No Statin
n=35 Participants
No historical use of a statin
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
|---|---|---|---|
|
Peak Unified Dyskinesia Rating Scale - Objective Measures
|
5.5 score on a scale
Standard Deviation 5.1
|
3.8 score on a scale
Standard Deviation 4.2
|
6.8 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Every half hour from 0900 to 1500Any score greater than or equal to 1 on the Clinical Dyskinesia Rating Scale (CDRS) during the intravenous levodopa cycle from 0900 - 1500. The CDRS is a commonly utilized scale that is completed by an observer who judges the severity of LID (0-4) in 7 body parts (face, neck, trunk, both legs, and both arms) during as the subject performs the cognitive distraction task while standing on the force plate for 60 seconds. CDRS ratings are made every half hour during the LD dose cycle by the principal investigator (KC) or co-investigator.
Outcome measures
| Measure |
Statin Before Levodopa
n=28 Participants
Historical use of a statin BEFORE beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
Statin After Levodopa
n=16 Participants
Historical use of a statin AFTER beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
No Statin
n=35 Participants
No historical use of a statin
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
|---|---|---|---|
|
Presence/Absence of Levodopa-induced Dyskinesia (LID).
|
16 Participants
|
8 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 11:00 amPopulation: Historical use of a statin BEFORE beginning levodopa: excluded 2 participants that could not stand for 1 minute; No historical use of a statin: excluded 1 participant that had a pre-syncopal episode and was given time to recover before resuming ratings.
The Clinical Dyskinesia Rating Scale (CDRS) is a commonly utilized scale that is completed by an observer who judges the severity of Levodopa induced dyskinesia (LID) in 7 body parts (face, neck, trunk, both legs, and both arms) during the force plate stance with a cognitive distraction task for 60 seconds. All body parts are rated separately on this 0 (none) to 4 (severe - markedly impairs activities) scale. Thus, the total score can range from 0 - 28 with 28 indicating the most severe LID. Peak CDRS ratings are the 11:00 am ratings.
Outcome measures
| Measure |
Statin Before Levodopa
n=26 Participants
Historical use of a statin BEFORE beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
Statin After Levodopa
n=16 Participants
Historical use of a statin AFTER beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
No Statin
n=34 Participants
No historical use of a statin
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
|---|---|---|---|
|
Clinical Dyskinesia Rating Scale (Peak)
|
1.9 score on a scale
Standard Deviation 2.6
|
1.6 score on a scale
Standard Deviation 2.8
|
3.6 score on a scale
Standard Deviation 3.1
|
Adverse Events
Statin Before Levodopa
Statin After Levodopa
No Statin
Serious adverse events
| Measure |
Statin Before Levodopa
n=29 participants at risk
Historical use of a statin BEFORE beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
Statin After Levodopa
n=16 participants at risk
Historical use of a statin AFTER beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
No Statin
n=35 participants at risk
No historical use of a statin
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1 • 3 months - time between the screening visit and completion of the day visit.
Total # at risk for All Cause Mortality: 88 - Includes those withdrawn during the AE collection period. Total # at risk for SAE/AE: 80 - Excludes those withdrawn, did not complete day visit and therefore not at risk of AE during levodopa infusion/day visit.
|
6.2%
1/16 • Number of events 1 • 3 months - time between the screening visit and completion of the day visit.
Total # at risk for All Cause Mortality: 88 - Includes those withdrawn during the AE collection period. Total # at risk for SAE/AE: 80 - Excludes those withdrawn, did not complete day visit and therefore not at risk of AE during levodopa infusion/day visit.
|
8.6%
3/35 • Number of events 3 • 3 months - time between the screening visit and completion of the day visit.
Total # at risk for All Cause Mortality: 88 - Includes those withdrawn during the AE collection period. Total # at risk for SAE/AE: 80 - Excludes those withdrawn, did not complete day visit and therefore not at risk of AE during levodopa infusion/day visit.
|
Other adverse events
| Measure |
Statin Before Levodopa
n=29 participants at risk
Historical use of a statin BEFORE beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
Statin After Levodopa
n=16 participants at risk
Historical use of a statin AFTER beginning levodopa
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
No Statin
n=35 participants at risk
No historical use of a statin
Intravenous Infusion: Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
|
|---|---|---|---|
|
Vascular disorders
LightHeadedness
|
0.00%
0/29 • 3 months - time between the screening visit and completion of the day visit.
Total # at risk for All Cause Mortality: 88 - Includes those withdrawn during the AE collection period. Total # at risk for SAE/AE: 80 - Excludes those withdrawn, did not complete day visit and therefore not at risk of AE during levodopa infusion/day visit.
|
6.2%
1/16 • Number of events 1 • 3 months - time between the screening visit and completion of the day visit.
Total # at risk for All Cause Mortality: 88 - Includes those withdrawn during the AE collection period. Total # at risk for SAE/AE: 80 - Excludes those withdrawn, did not complete day visit and therefore not at risk of AE during levodopa infusion/day visit.
|
2.9%
1/35 • Number of events 1 • 3 months - time between the screening visit and completion of the day visit.
Total # at risk for All Cause Mortality: 88 - Includes those withdrawn during the AE collection period. Total # at risk for SAE/AE: 80 - Excludes those withdrawn, did not complete day visit and therefore not at risk of AE during levodopa infusion/day visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place