Trial · NCT02005029
Erythromycin in Parkinson's Disease
NCT02005029, Not applicable, Completed, Virginia Commonwealth University; results first posted 2017-02-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Erythromycin in Parkinson's Disease. Trials, record NCT02005029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02005029
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erythromycin in Parkinson's Disease
- NCT number
- NCT02005029
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 18 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Parkinson's Disease, Levodopa
- Interventions
- Erythromycin, placebo
- First posted
- 2013-12-09
- Last updated
- 2017-02-03
- Results first posted
- 2017-02-03
- Limitations and caveats
- An overall limitation was the small sample size.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gastric Emptying Time | 2 weeks, between visits 2 and 3 | Mean gastric emptying time in minutes as measured by SmartPill |
| Primary | Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo | 2 weeks, between visits 2 and 3 | 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. |
| Secondary | 9-hole Peg Test Right Hand | 2 weeks, between visits 2 and 3 | 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. |
| Secondary | 9-hole Peg Test Left Hand | 2 weeks, between visits 2 and 3 | 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. |
| Secondary | Five Times Sit-to-stand Test | 2 weeks, between visits 2 and 3 | 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. |
| Secondary | Comfortable 20 Feet Gait Speed (CGS) | 2 weeks, between visits 2 and 3 | Change in motor function as assessed by comfortable 20 feet gait speed (CGS) |
| Secondary | Timed up and go Test (TUAG) Comfortable Speed | 2 weeks, between visits 2 and 3 | 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. |
| Secondary | Timed up and go Test (TUAG) Fast Speed | 2 weeks, between visits 2 and 3 | 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. |
| Secondary | Change in Dyskinesia | 2 weeks, between visits 2 and 3 | 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). |
| Secondary | MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale) | 2 weeks, between visits 2 and 3 | 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). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Gastric Emptying Time | 2 weeks, between visits 2 and 3 | 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. | minutes | MEAN |
| PRIMARY | Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo | 2 weeks, between visits 2 and 3 | 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. | ng/mL*min | MEAN |
| SECONDARY | 9-hole Peg Test Right Hand | 2 weeks, between visits 2 and 3 | 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. | seconds | MEAN |
| SECONDARY | 9-hole Peg Test Left Hand | 2 weeks, between visits 2 and 3 | 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. | seconds | MEAN |
| SECONDARY | Five Times Sit-to-stand Test | 2 weeks, between visits 2 and 3 | 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. | seconds | MEAN |
| SECONDARY | Comfortable 20 Feet Gait Speed (CGS) | 2 weeks, between visits 2 and 3 | 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. | seconds | MEAN |
| SECONDARY | Timed up and go Test (TUAG) Comfortable Speed | 2 weeks, between visits 2 and 3 | 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. | seconds | MEAN |
| SECONDARY | Timed up and go Test (TUAG) Fast Speed | 2 weeks, between visits 2 and 3 | 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. | seconds | MEAN |
| SECONDARY | Change in Dyskinesia | 2 weeks, between visits 2 and 3 | 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. | units on a scale | MEAN |
| SECONDARY | MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale) | 2 weeks, between visits 2 and 3 | One participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance. | units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Gastric Emptying Time | Erythromycin | 105 | Standard Deviation 66.5 | minutes | |
| Gastric Emptying Time | Placebo | 180 | Standard Deviation 40.6 | minutes | |
| Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo | Erythromycin | 123237 | Standard Deviation 137561 | ng/mL*min | |
| Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo | Placebo | 103584 | Standard Deviation 106271 | ng/mL*min | |
| 9-hole Peg Test Right Hand | Erythromycin | 25.36 | Standard Deviation 4.37 | seconds | |
| 9-hole Peg Test Right Hand | Placebo | 25.80 | Standard Deviation 4.23 | seconds | |
| 9-hole Peg Test Left Hand | Erythromycin | 29.36 | Standard Deviation 6.27 | seconds | |
| 9-hole Peg Test Left Hand | Placebo | 27.33 | Standard Deviation 6.45 | seconds | |
| Five Times Sit-to-stand Test | Erythromycin | 11.09 | Standard Deviation 2.24 | seconds | |
| Five Times Sit-to-stand Test | Placebo | 10.09 | Standard Deviation 2.48 | seconds |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (1 Day) | STARTED | Placebo First Then Erythromycin | 5 | |
| First Intervention (1 Day) | STARTED | Erythromycin Then Placebo | 5 | |
| First Intervention (1 Day) | COMPLETED | Placebo First Then Erythromycin | 4 | |
| First Intervention (1 Day) | COMPLETED | Erythromycin Then Placebo | 5 | |
| First Intervention (1 Day) | NOT COMPLETED | Placebo First Then Erythromycin | 1 | |
| First Intervention (1 Day) | NOT COMPLETED | Erythromycin Then Placebo | 0 | |
| Washout (2 Weeks) | STARTED | Placebo First Then Erythromycin | 4 | |
| Washout (2 Weeks) | STARTED | Erythromycin Then Placebo | 5 | |
| Washout (2 Weeks) | COMPLETED | Placebo First Then Erythromycin | 4 | |
| Washout (2 Weeks) | COMPLETED | Erythromycin Then Placebo | 5 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | symptomatic orthostasis | Cardiac disorders | Erythromycin | 1 | 9 | 1 |
| other | symptomatic orthostasis | Cardiac disorders | Placebo | 1 | 10 | 1 |
| other | akathisia | Nervous system disorders | Erythromycin | 1 | 9 | 1 |
| other | akathisia | Nervous system disorders | Placebo | 0 | 10 | 0 |
| other | diarrhea | Gastrointestinal disorders | Erythromycin | 1 | 9 | 1 |
| other | diarrhea | Gastrointestinal disorders | Placebo | 0 | 10 | 0 |
| other | possible hematuria | Renal and urinary disorders | Erythromycin | 1 | 9 | 1 |
| other | possible hematuria | Renal and urinary disorders | Placebo | 0 | 10 | 0 |
| other | transaminitis | Hepatobiliary disorders | Erythromycin | 0 | 9 | 0 |
| other | transaminitis | Hepatobiliary disorders | Placebo | 1 | 10 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erythromycin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Erythromycin | 4 | 9 |
| Total, other adverse events | Placebo | 2 | 10 |
| Total, serious adverse events | Erythromycin | 0 | 9 |
| Total, serious adverse events | Placebo | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Erythromycin vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02005029
GET https://conductscience.org/api/trials/v1/NCT02005029/results?page=2