Trial Outcomes & Findings for Developing Objective Measures of Levodopa Induced Dyskinesia: (Study 1) (NCT NCT00467597)
NCT ID: NCT00467597
Last Updated: 2014-11-26
Results Overview
Gaitmat stance measurements were measured every half hour throughout an 8 hour period. Area under the curve was computed using the trapezoidal method for root mean squared velocity in the anterior-posterior direction. Each subject's unique baseline was used by computing the mean of the test-retest period measured at 08:00 am.
Recruitment status
COMPLETED
Target enrollment
36 participants
Primary outcome timeframe
Every 1/2 hour during an 8 hour period.
Results posted on
2014-11-26
Participant Flow
Participant milestones
| Measure |
Parkinson's Disease
Parkinson's disease with and without Levodopa-Induced Dyskinesia (no intervention).
|
Controls
Non-Parkinson's Disease Controls (no intervention).
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
6
|
|
Overall Study
COMPLETED
|
24
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Parkinson's Disease
Parkinson's disease with and without Levodopa-Induced Dyskinesia (no intervention).
|
Controls
Non-Parkinson's Disease Controls (no intervention).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Developing Objective Measures of Levodopa Induced Dyskinesia: (Study 1)
Baseline characteristics by cohort
| Measure |
PD - No LID
n=6 Participants
Parkinson's disease without levodopa-induced dyskinesia
|
PD - Mild LID
n=11 Participants
Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS \<= 7)
|
PD - Mod LID
n=4 Participants
Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS \> 8)
|
Controls - No PD
n=6 Participants
Controls with no Parkinson's disease
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
68.3 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
64.0 years
STANDARD_DEVIATION 8.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
27 participants
n=21 Participants
|
|
Duration of Disease (years)
|
4.7 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
10.2 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
10.5 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
0 years
STANDARD_DEVIATION 0 • n=4 Participants
|
9.5 years
STANDARD_DEVIATION 5.9 • n=21 Participants
|
|
UPDRS (part III)
|
21.3 units on a scale
STANDARD_DEVIATION 7.9 • n=5 Participants
|
23.5 units on a scale
STANDARD_DEVIATION 12.7 • n=7 Participants
|
12.0 units on a scale
STANDARD_DEVIATION 8.0 • n=5 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=4 Participants
|
15.3 units on a scale
STANDARD_DEVIATION 13.1 • n=21 Participants
|
|
mAIMS at Screening
|
0 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
1.6 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
11.8 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=4 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 5.0 • n=21 Participants
|
PRIMARY outcome
Timeframe: Every 1/2 hour during an 8 hour period.Gaitmat stance measurements were measured every half hour throughout an 8 hour period. Area under the curve was computed using the trapezoidal method for root mean squared velocity in the anterior-posterior direction. Each subject's unique baseline was used by computing the mean of the test-retest period measured at 08:00 am.
Outcome measures
| Measure |
PD - No LID
n=6 Participants
Parkinson's disease without levodopa-induced dyskinesia
|
PD - Mild LID
n=11 Participants
Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS \<= 7)
|
PD - Mod LID
n=4 Participants
Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS \> 8)
|
Controls - No PD
n=6 Participants
Controls with no Parkinson's disease
|
|---|---|---|---|---|
|
Gaitmat Stance Measurements (AUC)
|
4.48 Root Mean Square of Velocity*Minutes
Standard Deviation 2.1
|
10.8 Root Mean Square of Velocity*Minutes
Standard Deviation 12.1
|
20.9 Root Mean Square of Velocity*Minutes
Standard Deviation 26.0
|
2.8 Root Mean Square of Velocity*Minutes
Standard Deviation 0.95
|
Adverse Events
PD - No LID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PD - Mild LID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PD - Mod LID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls - No PD
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
Kathryn Chung, MD
Portland VA Health Care System (PORVAHCS)
Phone: 503.220.8262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place