Erythromycin in Parkinson's Disease

NCT ID: NCT02005029

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-06-30

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.

Conditions

Parkinson's Disease; Levodopa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

One time IV dose of placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Erythromycin

One time IV dose of 100 mg Erythromycin

Group Type: EXPERIMENTAL

Erythromycin

Intervention Type: DRUG

Interventions

Erythromycin

Intervention Type: DRUG

placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie J Cloud, M.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University Parkinson's Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM15105

Identifier Type: -

Identifier Source: org_study_id