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Trial record 6 of 180 for:    ERYTHROMYCIN

Erythromycin in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02005029
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Parkinson's Disease
Levodopa
Interventions Drug: Erythromycin
Drug: placebo
Enrollment 18
Recruitment Details Eighteen patients were screened for eligibility between April 2013 and June 2015 at the Virginia Commonwealth University Parkinson's and Movement Disorders Center.
Pre-assignment Details 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 Of those not randomized, 7 did not meet eligibility criteria and 1 was withdrawn by the principal investigator prior to randomization due to noncompliance with the protocol.
Arm/Group Title Placebo First Then Erythromycin Erythromycin Then Placebo
Hide Arm/Group Description One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout) One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
Period Title: First Intervention (1 Day)
Started 5 5
Completed 4 5
Not Completed 1 0
Reason Not Completed
participant withdrawn for noncompliance             1             0
Period Title: Washout (2 Weeks)
Started 4 5
Completed 4 5
Not Completed 0 0
Period Title: Second Intervention (1 Day)
Started 4 5
Completed 4 5
Not Completed 0 0
Arm/Group Title Placebo First Then Erythromycin Erythromycin Then Placebo Total
Hide Arm/Group Description One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout) One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout) Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
64.6
(51 to 77)
64.0
(50 to 76)
64.3
(50 to 77)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
1
  20.0%
1
  20.0%
2
  20.0%
Male
4
  80.0%
4
  80.0%
8
  80.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
5
 100.0%
5
 100.0%
10
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5
 100.0%
5
 100.0%
10
 100.0%
1.Primary Outcome
Title Gastric Emptying Time
Hide Description Mean gastric emptying time in minutes as measured by SmartPill
Time Frame 2 weeks, between visits 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:
Mean gastric emptying time for participants receiving erythromycin
Mean gastric emptying time for participants receiving placebo
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: minutes
105  (66.5) 180  (40.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo
Hide Description 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.
Time Frame 2 weeks, between visits 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:
Area under the curve 0-4 hours for plasma levodopa after erythromycin
Area under the curve 0-4 hours for plasma levodopa after placebo
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: ng/mL*min
123237  (137561) 103584  (106271)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Erythromycin:Placebo AUC ratio
Estimated Value 1.07
Parameter Dispersion
Type: Standard Deviation
Value: 0.43
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 9-hole Peg Test Right Hand
Hide Description 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.
Time Frame 2 weeks, between visits 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:
Mean time for right hand after erythromycin
Mean time for right hand after placebo
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: seconds
25.36  (4.37) 25.80  (4.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title 9-hole Peg Test Left Hand
Hide Description 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.
Time Frame 2 weeks, between visits 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:
Mean time for right hand after erythromycin
Mean time for right hand after placebo
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: seconds
29.36  (6.27) 27.33  (6.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Five Times Sit-to-stand Test
Hide Description 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.
Time Frame 2 weeks, between visits 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:
Five times sit-to-stand for all participants receiving erythromycin
Five times sit-to-stand for all participants receiving placebo
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: seconds
11.09  (2.24) 10.09  (2.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4405
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Comfortable 20 Feet Gait Speed (CGS)
Hide Description Change in motor function as assessed by comfortable 20 feet gait speed (CGS)
Time Frame 2 weeks, between visits 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:
Mean CGS for all participants receiving erythromycin
Mean CGS for all participants receiving placebo
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: seconds
4.26  (0.44) 4.10  (0.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6011
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Timed up and go Test (TUAG) Comfortable Speed
Hide Description 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.
Time Frame 2 weeks, between visits 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:
TUAG (comfortable speed) after erythromycin
TUAG (comfortable speed) after placebo
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: seconds
8.67  (1.33) 8.26  (1.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8923
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Timed up and go Test (TUAG) Fast Speed
Hide Description 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.
Time Frame 2 weeks, between visits 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:
TUAG (fast speed) after erythromycin
TUAG (fast speed) after placebo
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: seconds
6.79  (0.927) 6.85  (1.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.832
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Change in Dyskinesia
Hide Description 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).
Time Frame 2 weeks, between visits 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:
AIMS after receiving erythromycin
AIMS after receiving placebo
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.875  (1.458) 0.375  (1.061)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1546
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)
Hide Description 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).
Time Frame 2 weeks, between visits 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
One participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Before or "off" levodopa 30.75  (13.26) 25.37  (11.09)
After or "on" levodopa 17.13  (11.48) 16.50  (8.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0314
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.75
Parameter Dispersion
Type: Standard Deviation
Value: 5.00
Estimation Comments Mean difference in "on" score versus "off" score from the MDS UPDRS Part 3 on day of erythromycin minus the mean difference in 'on" score versus "off" score on day of placebo.
11.Secondary Outcome
Title Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo
Hide Description 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.
Time Frame 2 weeks, between visits 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:
Cmax of plasma levodopa after erythromycin
Cmax of plasma levodopa after placebo
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
1267  (1012) 1395  (1015)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Erythromycin:Placebo Cmax ratio
Estimated Value 0.83
Parameter Dispersion
Type: Standard Deviation
Value: 0.24
Estimation Comments [Not Specified]
Time Frame 1 year, 10 months
Adverse Event Reporting Description Participants were followed from the beginning to the end of their active participation or the resolution of any adverse events.
 
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description Participants who received a one time dose of IV erythromycin Participants who received a one time dose of placebo
All-Cause Mortality
Erythromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Erythromycin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erythromycin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/9 (44.44%)      2/10 (20.00%)    
Cardiac disorders     
symptomatic orthostasis * [1]  1/9 (11.11%)  1 1/10 (10.00%)  1
Gastrointestinal disorders     
diarrhea * [2]  1/9 (11.11%)  1 0/10 (0.00%)  0
Hepatobiliary disorders     
transaminitis * [3]  0/9 (0.00%)  0 1/10 (10.00%)  1
Nervous system disorders     
akathisia * [4]  1/9 (11.11%)  1 0/10 (0.00%)  0
Renal and urinary disorders     
possible hematuria * [5]  1/9 (11.11%)  1 0/10 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
One participant developed symptomatic orthostatic hypotension during both her erythromycin and placebo dosing days. This resolved within a few minutes following sips of water and rest.
[2]
One participant developed a single episode of loose stool during her erythromycin dosing day. No intervention was necessary.
[3]
One participant had a mild transaminitis identified at his final safety visit (after placebo dosing day). This was thought to be due to over use of pain medication for an acute back injury. This resolved after stopping pain medication.
[4]
One participant developed self limited akathisia after taking levodopa during his erythromycin dosing day. This resolved after a few minutes with no intervention.
[5]
One participant had trace hematuria on urinalysis from his final safety visit (occurring after his erythromycin dosing day). Urinalysis was repeated by primary care provider one day later and was normal.
An overall limitation was the small sample size.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Leslie Cloud
Organization: Virginia Commonwealth University
Phone: 804-662-5304
EMail: leslie.cloud@vcuhealth.org
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02005029     History of Changes
Other Study ID Numbers: HM15105
First Submitted: September 18, 2013
First Posted: December 9, 2013
Results First Submitted: October 3, 2016
Results First Posted: February 3, 2017
Last Update Posted: February 3, 2017