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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

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Levodopa Drug: Erythromycin Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Erythromycin in Parkinson's Disease: A Pilot Study of Its Effects on Levodopa Pharmacokinetics and Pharmacodynamics
Study Start Date : April 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015


Arm Intervention/treatment
Placebo Comparator: Placebo
One time IV dose of placebo
Drug: placebo
Experimental: Erythromycin
One time IV dose of 100 mg Erythromycin
Drug: Erythromycin



Primary Outcome Measures :
  1. Gastric Emptying Time [ Time Frame: 2 weeks, between visits 2 and 3 ]
    Mean gastric emptying time in minutes as measured by SmartPill

  2. Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo [ Time Frame: 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 Outcome Measures :
  1. 9-hole Peg Test Right Hand [ Time Frame: 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.

  2. 9-hole Peg Test Left Hand [ Time Frame: 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.

  3. Five Times Sit-to-stand Test [ Time Frame: 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.

  4. Comfortable 20 Feet Gait Speed (CGS) [ Time Frame: 2 weeks, between visits 2 and 3 ]
    Change in motor function as assessed by comfortable 20 feet gait speed (CGS)

  5. Timed up and go Test (TUAG) Comfortable Speed [ Time Frame: 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.

  6. Timed up and go Test (TUAG) Fast Speed [ Time Frame: 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.

  7. Change in Dyskinesia [ Time Frame: 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).

  8. MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale) [ Time Frame: 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).

  9. Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo [ Time Frame: 2 weeks, between visits 2 and 3 ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005029


Locations
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United States, Virginia
Virginia Commonwealth University Parkinson's Center
Richmond, Virginia, United States, 23230
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Leslie J Cloud, M.D. Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02005029     History of Changes
Other Study ID Numbers: HM15105
First Posted: December 9, 2013    Key Record Dates
Results First Posted: February 3, 2017
Last Update Posted: February 3, 2017
Last Verified: December 2016

Keywords provided by Virginia Commonwealth University:
Parkinson's Disease
Levodopa
motor fluctuations
gastroparesis

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors