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Erythromycin in Parkinson's Disease

Primary Purpose

Parkinson's Disease, Levodopa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erythromycin
placebo
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Levodopa, motor fluctuations, gastroparesis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have a definitive diagnosis of Parkinson's Disease (per United Kingdom brain bank criteria), Hoehn and Yahr stage 1-3,
  • must exhibit unequivocal levodopa responsiveness
  • must be able to distinguish between the "off" versus "on" state
  • Subjects must be on a stable dose of levodopa for at least 28 days prior to enrollment and should be anticipated to maintain a stable dose throughout both study periods
  • Subjects may be on concomitant therapy with Monoamine oxidase B inhibitors, entacapone, and amantadine, though the doses of these medications must have remained stable for at least 28 days prior to enrollment and must be expected to remain stable throughout both study periods.

Exclusion Criteria:

  • History of deep brain stimulation for Parkinson Disease
  • History of ablative (tissue removal) surgery for Parkinson Disease
  • Presence of dementia (MMSE<25)
  • Presence of active psychosis
  • History of any chronic gastrointestinal diseases
  • History of any prior gastrointestinal surgeries except for appendectomy, cholecystectomy, and hysterectomy
  • Any gastrointestinal surgeries in the past 3 months
  • Severe dysphagia (difficulty swallowing) to pills or food
  • History of physiological or mechanical gastrointestinal obstruction
  • History of strictures or fistulae (abnormal or narrow connections) along the gastrointestinal tract
  • History of gastric bezoars (undigested mass)
  • Allergy to wheat, soy, milk, or nuts
  • Presence of portable electromechanical devices such as pacemaker, defibrillator, or infusion pump
  • Female subjects who are pregnant or lactating
  • Symptomatic orthostatic hypotension (low blood pressure)
  • Diabetes
  • Presence of symptomatic anemia
  • Abnormal liver or kidney function
  • Cardiac arrhythmia (past or present) or abnormal QT interval on entrance EKG
  • Known hypersensitivity to any of the study drugs
  • Subjects receiving certain medications during specified time frames

Sites / Locations

  • Virginia Commonwealth University Parkinson's Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Erythromycin

Arm Description

One time IV dose of placebo

One time IV dose of 100 mg Erythromycin

Outcomes

Primary Outcome Measures

Gastric Emptying Time
Mean gastric emptying time in minutes as measured by SmartPill
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.

Secondary Outcome Measures

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.
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.
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.
Comfortable 20 Feet Gait Speed (CGS)
Change in motor function as assessed by comfortable 20 feet gait speed (CGS)
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.
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.
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).
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).
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.

Full Information

First Posted
September 18, 2013
Last Updated
December 15, 2016
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT02005029
Brief Title
Erythromycin in Parkinson's Disease
Official Title
Erythromycin in Parkinson's Disease: A Pilot Study of Its Effects on Levodopa Pharmacokinetics and Pharmacodynamics
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Levodopa
Keywords
Parkinson's Disease, Levodopa, motor fluctuations, gastroparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One time IV dose of placebo
Arm Title
Erythromycin
Arm Type
Experimental
Arm Description
One time IV dose of 100 mg Erythromycin
Intervention Type
Drug
Intervention Name(s)
Erythromycin
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Gastric Emptying Time
Description
Mean gastric emptying time in minutes as measured by SmartPill
Time Frame
2 weeks, between visits 2 and 3
Title
Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo
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
Secondary Outcome Measure Information:
Title
9-hole Peg Test Right Hand
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
Title
9-hole Peg Test Left Hand
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
Title
Five Times Sit-to-stand Test
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
Title
Comfortable 20 Feet Gait Speed (CGS)
Description
Change in motor function as assessed by comfortable 20 feet gait speed (CGS)
Time Frame
2 weeks, between visits 2 and 3
Title
Timed up and go Test (TUAG) Comfortable Speed
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
Title
Timed up and go Test (TUAG) Fast Speed
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
Title
Change in Dyskinesia
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
Title
MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)
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
Title
Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have a definitive diagnosis of Parkinson's Disease (per United Kingdom brain bank criteria), Hoehn and Yahr stage 1-3, must exhibit unequivocal levodopa responsiveness must be able to distinguish between the "off" versus "on" state Subjects must be on a stable dose of levodopa for at least 28 days prior to enrollment and should be anticipated to maintain a stable dose throughout both study periods Subjects may be on concomitant therapy with Monoamine oxidase B inhibitors, entacapone, and amantadine, though the doses of these medications must have remained stable for at least 28 days prior to enrollment and must be expected to remain stable throughout both study periods. Exclusion Criteria: History of deep brain stimulation for Parkinson Disease History of ablative (tissue removal) surgery for Parkinson Disease Presence of dementia (MMSE<25) Presence of active psychosis History of any chronic gastrointestinal diseases History of any prior gastrointestinal surgeries except for appendectomy, cholecystectomy, and hysterectomy Any gastrointestinal surgeries in the past 3 months Severe dysphagia (difficulty swallowing) to pills or food History of physiological or mechanical gastrointestinal obstruction History of strictures or fistulae (abnormal or narrow connections) along the gastrointestinal tract History of gastric bezoars (undigested mass) Allergy to wheat, soy, milk, or nuts Presence of portable electromechanical devices such as pacemaker, defibrillator, or infusion pump Female subjects who are pregnant or lactating Symptomatic orthostatic hypotension (low blood pressure) Diabetes Presence of symptomatic anemia Abnormal liver or kidney function Cardiac arrhythmia (past or present) or abnormal QT interval on entrance EKG Known hypersensitivity to any of the study drugs Subjects receiving certain medications during specified time frames
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie J Cloud, M.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University Parkinson's Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States

12. IPD Sharing Statement

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Erythromycin in Parkinson's Disease

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