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Erythromycin in Parkinson's Disease

Information source: Virginia Commonwealth University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson's Disease; Levodopa

Intervention: Erythromycin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Virginia Commonwealth University

Official(s) and/or principal investigator(s):
Leslie J Cloud, M.D., Principal Investigator, Affiliation: Virginia Commonwealth University

Overall contact:
Ginger Norris, M.G.C., Phone: 804-662-5300, Email: vwnorris@vcu.edu


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.

Clinical Details

Official title: Erythromycin in Parkinson's Disease: A Pilot Study of Its Effects on Levodopa Pharmacokinetics and Pharmacodynamics

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Change in gastric emptying time as measured by Smart pill

Change in Area under the Curve 0-4 hours for plasma levodopa after a single dose of sinemet

Secondary outcome:

Change in Cmax for plasma levodopa

change in latency to "on" following a single dose of Sinemet

Change in total duration of "on" time in minutes from a single dose of Sinemet

Change in motor function and dyskinesia

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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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

Locations and Contacts

Ginger Norris, M.G.C., Phone: 804-662-5300, Email: vwnorris@vcu.edu

Virginia Commonwealth University Parkinson's Center, Richmond, Virginia 23230, United States; Recruiting
Ginger Norris, Phone: 804-662-5300, Email: vwnorris@vcu.edu
Leslie J Cloud, MD, MSc, Principal Investigator
Additional Information

Starting date: April 2013
Last updated: May 18, 2015

Page last updated: August 23, 2015

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