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Gastroparesis (slow stomach emptying) is a common feature of Parkinson's Disease. Levodopa (Sinemet), a common medication for Parkinson's Disease, can make gastroparesis worse. Gastroparesis effects how the levodopa is absorbed and used by the body. This study will explore the possibility of using Erythromycin, a drug commonly used (off label) for gastroparesis, along with levodopa to determine if there is improved levodopa absorption and motor function.
Participants will be required to make four visits for evaluation. Visit 1 is a screening visit, participants will receive the study drug or a placebo during visits 2 and 3, and visit 4 is a follow up visit. Participants will provide blood and urine samples during the visits. Participants will also be required to complete questionnaires and a series of motor tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | One time IV dose of placebo |
|
| Erythromycin | Experimental | One time IV dose of 100 mg Erythromycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythromycin | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric Emptying Time | Mean gastric emptying time in minutes as measured by SmartPill | 2 weeks, between visits 2 and 3 |
| Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo | 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. | 2 weeks, between visits 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 9-hole Peg Test Right Hand | 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. | 2 weeks, between visits 2 and 3 |
| 9-hole Peg Test Left Hand |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie J Cloud, M.D. | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University Parkinson's Center | Richmond | Virginia | 23230 | United States |
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.
Eighteen patients were screened for eligibility between April 2013 and June 2015 at the Virginia Commonwealth University Parkinson's and Movement Disorders Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First Then Erythromycin | One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout) |
| FG001 | Erythromycin Then Placebo | One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
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| ||||||||||||||||||
| Washout (2 Weeks) |
| |||||||||||||||||||
| Second Intervention (1 Day) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo First Then Erythromycin | One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout) |
| BG001 | Erythromycin Then Placebo | One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gastric Emptying Time | Mean gastric emptying time in minutes as measured by SmartPill | 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. | Posted | Mean | Standard Deviation | minutes | 2 weeks, between visits 2 and 3 |
|
1 year, 10 months
Participants were followed from the beginning to the end of their active participation or the resolution of any adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erythromycin | Participants who received a one time dose of IV erythromycin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| symptomatic orthostasis | Cardiac disorders | Non-systematic Assessment | 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. |
An overall limitation was the small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leslie Cloud | Virginia Commonwealth University | 804-662-5304 | leslie.cloud@vcuhealth.org |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004917 | Erythromycin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
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. |
| 2 weeks, between visits 2 and 3 |
| Five Times Sit-to-stand Test | 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. | 2 weeks, between visits 2 and 3 |
| Comfortable 20 Feet Gait Speed (CGS) | Change in motor function as assessed by comfortable 20 feet gait speed (CGS) | 2 weeks, between visits 2 and 3 |
| Timed up and go Test (TUAG) Comfortable Speed | 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. | 2 weeks, between visits 2 and 3 |
| Timed up and go Test (TUAG) Fast Speed | 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. | 2 weeks, between visits 2 and 3 |
| Change in Dyskinesia | 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). | 2 weeks, between visits 2 and 3 |
| MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale) | 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). | 2 weeks, between visits 2 and 3 |
| Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo | 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. | 2 weeks, between visits 2 and 3 |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Primary | Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo | 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. | 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. | Posted | Mean | Standard Deviation | ng/mL*min | 2 weeks, between visits 2 and 3 |
|
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|
|
| Secondary | 9-hole Peg Test Right Hand | 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. | 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. | Posted | Mean | Standard Deviation | seconds | 2 weeks, between visits 2 and 3 |
|
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|
|
| Secondary | 9-hole Peg Test Left Hand | 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. | 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. | Posted | Mean | Standard Deviation | seconds | 2 weeks, between visits 2 and 3 |
|
|
|
|
| Secondary | Five Times Sit-to-stand Test | 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. | 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. | Posted | Mean | Standard Deviation | seconds | 2 weeks, between visits 2 and 3 |
|
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|
|
| Secondary | Comfortable 20 Feet Gait Speed (CGS) | Change in motor function as assessed by comfortable 20 feet gait speed (CGS) | 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. | Posted | Mean | Standard Deviation | seconds | 2 weeks, between visits 2 and 3 |
|
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|
|
| Secondary | Timed up and go Test (TUAG) Comfortable Speed | 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. | 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. | Posted | Mean | Standard Deviation | seconds | 2 weeks, between visits 2 and 3 |
|
|
|
|
| Secondary | Timed up and go Test (TUAG) Fast Speed | 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. | 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. | Posted | Mean | Standard Deviation | seconds | 2 weeks, between visits 2 and 3 |
|
|
|
|
| Secondary | Change in Dyskinesia | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks, between visits 2 and 3 |
|
|
|
|
| Secondary | MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale) | 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). | One participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks, between visits 2 and 3 |
|
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| Secondary | Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo | 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | 2 weeks, between visits 2 and 3 |
|
|
|
|
| 0 |
| 9 |
| 4 |
| 9 |
| EG001 | Placebo | Participants who received a one time dose of placebo | 0 | 10 | 2 | 10 |
|
| akathisia | Nervous system disorders | Non-systematic Assessment | One participant developed self limited akathisia after taking levodopa during his erythromycin dosing day. This resolved after a few minutes with no intervention. |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment | One participant developed a single episode of loose stool during her erythromycin dosing day. No intervention was necessary. |
|
| possible hematuria | Renal and urinary disorders | Non-systematic Assessment | 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. |
|
| transaminitis | Hepatobiliary disorders | Non-systematic Assessment | 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. |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |