Trial Outcomes & Findings for Erythromycin in Parkinson's Disease (NCT NCT02005029)
NCT ID: NCT02005029
Last Updated: 2017-02-03
Results Overview
Mean gastric emptying time in minutes as measured by SmartPill
COMPLETED
NA
18 participants
2 weeks, between visits 2 and 3
2017-02-03
Participant Flow
Eighteen patients were screened for eligibility between April 2013 and June 2015 at the Virginia Commonwealth University Parkinson's and Movement Disorders Center.
10 of 18 participants were randomized. Of those not randomized, 7 did not meet eligibility criteria and 1 was withdrawn by the principal investigator prior to randomization due to noncompliance with the protocol.
Participant milestones
| Measure |
Placebo First Then Erythromycin
One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout)
|
Erythromycin Then Placebo
One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
5
|
5
|
|
First Intervention (1 Day)
COMPLETED
|
4
|
5
|
|
First Intervention (1 Day)
NOT COMPLETED
|
1
|
0
|
|
Washout (2 Weeks)
STARTED
|
4
|
5
|
|
Washout (2 Weeks)
COMPLETED
|
4
|
5
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
4
|
5
|
|
Second Intervention (1 Day)
COMPLETED
|
4
|
5
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo First Then Erythromycin
One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout)
|
Erythromycin Then Placebo
One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
|
|---|---|---|
|
First Intervention (1 Day)
participant withdrawn for noncompliance
|
1
|
0
|
Baseline Characteristics
Erythromycin in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Placebo First Then Erythromycin
n=5 Participants
One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout)
|
Erythromycin Then Placebo
n=5 Participants
One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
n=5 Participants
|
64.0 years
n=7 Participants
|
64.3 years
n=5 Participants
|
|
Gender
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 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
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 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
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeks, between visits 2 and 3Population: Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and four participants were unable to complete a SmartPill evaluation.
Mean gastric emptying time in minutes as measured by SmartPill
Outcome measures
| Measure |
Erythromycin
n=4 Participants
Mean gastric emptying time for participants receiving erythromycin
|
Placebo
n=4 Participants
Mean gastric emptying time for participants receiving placebo
|
|---|---|---|
|
Gastric Emptying Time
|
105 minutes
Standard Deviation 66.5
|
180 minutes
Standard Deviation 40.6
|
PRIMARY outcome
Timeframe: 2 weeks, between visits 2 and 3Population: Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and one participant had undetectable plasma levodopa levels through out the study and was thus excluded from the pharmacokinetic analysis.
Mean Area under the Curve 0-4 hours for plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes.
Outcome measures
| Measure |
Erythromycin
n=7 Participants
Mean gastric emptying time for participants receiving erythromycin
|
Placebo
n=7 Participants
Mean gastric emptying time for participants receiving placebo
|
|---|---|---|
|
Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo
|
123237 ng/mL*min
Standard Deviation 137561
|
103584 ng/mL*min
Standard Deviation 106271
|
SECONDARY outcome
Timeframe: 2 weeks, between visits 2 and 3Population: Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.
Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately.
Outcome measures
| Measure |
Erythromycin
n=8 Participants
Mean gastric emptying time for participants receiving erythromycin
|
Placebo
n=8 Participants
Mean gastric emptying time for participants receiving placebo
|
|---|---|---|
|
9-hole Peg Test Right Hand
|
25.36 seconds
Standard Deviation 4.37
|
25.80 seconds
Standard Deviation 4.23
|
SECONDARY outcome
Timeframe: 2 weeks, between visits 2 and 3Population: Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.
Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately.
Outcome measures
| Measure |
Erythromycin
n=8 Participants
Mean gastric emptying time for participants receiving erythromycin
|
Placebo
n=8 Participants
Mean gastric emptying time for participants receiving placebo
|
|---|---|---|
|
9-hole Peg Test Left Hand
|
29.36 seconds
Standard Deviation 6.27
|
27.33 seconds
Standard Deviation 6.45
|
SECONDARY outcome
Timeframe: 2 weeks, between visits 2 and 3Population: Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.
Change in motor function as measured by Five times sit-to-stand test. This test measures the total time to complete 5 repetitions of sit to stand.
Outcome measures
| Measure |
Erythromycin
n=8 Participants
Mean gastric emptying time for participants receiving erythromycin
|
Placebo
n=8 Participants
Mean gastric emptying time for participants receiving placebo
|
|---|---|---|
|
Five Times Sit-to-stand Test
|
11.09 seconds
Standard Deviation 2.24
|
10.09 seconds
Standard Deviation 2.48
|
SECONDARY outcome
Timeframe: 2 weeks, between visits 2 and 3Population: Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.
Change in motor function as assessed by comfortable 20 feet gait speed (CGS)
Outcome measures
| Measure |
Erythromycin
n=8 Participants
Mean gastric emptying time for participants receiving erythromycin
|
Placebo
n=8 Participants
Mean gastric emptying time for participants receiving placebo
|
|---|---|---|
|
Comfortable 20 Feet Gait Speed (CGS)
|
4.26 seconds
Standard Deviation 0.44
|
4.10 seconds
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: 2 weeks, between visits 2 and 3Population: Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.
Change in motor function as assessed by timed up and go test (comfortable speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting.
Outcome measures
| Measure |
Erythromycin
n=8 Participants
Mean gastric emptying time for participants receiving erythromycin
|
Placebo
n=8 Participants
Mean gastric emptying time for participants receiving placebo
|
|---|---|---|
|
Timed up and go Test (TUAG) Comfortable Speed
|
8.67 seconds
Standard Deviation 1.33
|
8.26 seconds
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: 2 weeks, between visits 2 and 3Population: Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.
Change in motor function as assessed by timed up and go test (fast speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting.
Outcome measures
| Measure |
Erythromycin
n=8 Participants
Mean gastric emptying time for participants receiving erythromycin
|
Placebo
n=8 Participants
Mean gastric emptying time for participants receiving placebo
|
|---|---|---|
|
Timed up and go Test (TUAG) Fast Speed
|
6.79 seconds
Standard Deviation 0.927
|
6.85 seconds
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: 2 weeks, between visits 2 and 3Population: Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.
Mean total AIMS (Abnormal Involuntary Movements Scale) score after receiving erythromycin minus mean total AIMS score after receiving placebo. The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. Ten of the items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Two of the items are not scored. Total score range is from 0 to 40. Higher scores represent more severe dyskinesia (a worse outcome).
Outcome measures
| Measure |
Erythromycin
n=8 Participants
Mean gastric emptying time for participants receiving erythromycin
|
Placebo
n=8 Participants
Mean gastric emptying time for participants receiving placebo
|
|---|---|---|
|
Change in Dyskinesia
|
0.875 units on a scale
Standard Deviation 1.458
|
0.375 units on a scale
Standard Deviation 1.061
|
SECONDARY outcome
Timeframe: 2 weeks, between visits 2 and 3Population: One participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.
Part 3 of this scale is a standardized physical assessment that quantifies the total burden of motor symptoms in Parkinson's disease patients. Each of the 18 items on the scale is rated from 0 (none, 1 (slight), 2 (mild), 3 (moderate) and 4 (severe). Scores range from 0-72. Higher scores represent a more severe burden of motor symptoms (a worse outcome).
Outcome measures
| Measure |
Erythromycin
n=8 Participants
Mean gastric emptying time for participants receiving erythromycin
|
Placebo
n=8 Participants
Mean gastric emptying time for participants receiving placebo
|
|---|---|---|
|
MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)
Before or "off" levodopa
|
30.75 units on a scale
Standard Deviation 13.26
|
25.37 units on a scale
Standard Deviation 11.09
|
|
MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)
After or "on" levodopa
|
17.13 units on a scale
Standard Deviation 11.48
|
16.50 units on a scale
Standard Deviation 8.38
|
SECONDARY outcome
Timeframe: 2 weeks, between visits 2 and 3Population: Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and one participant had undetectable plasma levodopa levels throughout the study and was thus excluded from the pharmacokinetic analysis.
Mean Cmax of plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes.
Outcome measures
| Measure |
Erythromycin
n=7 Participants
Mean gastric emptying time for participants receiving erythromycin
|
Placebo
n=7 Participants
Mean gastric emptying time for participants receiving placebo
|
|---|---|---|
|
Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo
|
1267 ng/mL
Standard Deviation 1012
|
1395 ng/mL
Standard Deviation 1015
|
Adverse Events
Erythromycin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Erythromycin
n=9 participants at risk
Participants who received a one time dose of IV erythromycin
|
Placebo
n=10 participants at risk
Participants who received a one time dose of placebo
|
|---|---|---|
|
Cardiac disorders
symptomatic orthostasis
|
11.1%
1/9 • Number of events 1 • 1 year, 10 months
Participants were followed from the beginning to the end of their active participation or the resolution of any adverse events.
|
10.0%
1/10 • Number of events 1 • 1 year, 10 months
Participants were followed from the beginning to the end of their active participation or the resolution of any adverse events.
|
|
Nervous system disorders
akathisia
|
11.1%
1/9 • Number of events 1 • 1 year, 10 months
Participants were followed from the beginning to the end of their active participation or the resolution of any adverse events.
|
0.00%
0/10 • 1 year, 10 months
Participants were followed from the beginning to the end of their active participation or the resolution of any adverse events.
|
|
Gastrointestinal disorders
diarrhea
|
11.1%
1/9 • Number of events 1 • 1 year, 10 months
Participants were followed from the beginning to the end of their active participation or the resolution of any adverse events.
|
0.00%
0/10 • 1 year, 10 months
Participants were followed from the beginning to the end of their active participation or the resolution of any adverse events.
|
|
Renal and urinary disorders
possible hematuria
|
11.1%
1/9 • Number of events 1 • 1 year, 10 months
Participants were followed from the beginning to the end of their active participation or the resolution of any adverse events.
|
0.00%
0/10 • 1 year, 10 months
Participants were followed from the beginning to the end of their active participation or the resolution of any adverse events.
|
|
Hepatobiliary disorders
transaminitis
|
0.00%
0/9 • 1 year, 10 months
Participants were followed from the beginning to the end of their active participation or the resolution of any adverse events.
|
10.0%
1/10 • Number of events 1 • 1 year, 10 months
Participants were followed from the beginning to the end of their active participation or the resolution of any adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place