Erythromycin in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005029
• Other study ID #: HM15105
• Status: Completed
• Phase: N/A
• First received: September 18, 2013
• Last updated: December 10, 2015
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Levodopa
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Erythromycin

• placebo

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Parkinson's Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gastric emptying time as measured by Smart pill	Gastric emptying time	2 weeks, between visits 2 and 3	No
Primary	Change in Area under the Curve 0-4 hours for plasma levodopa after a single dose of sinemet		2 weeks, between visits 2 and 3	No
Secondary	Change in Cmax for plasma levodopa		2 weeks, between visits 2 and 3	No
Secondary	change in latency to "on" following a single dose of Sinemet		2 weeks, between visits 2 and 3	No
Secondary	Change in total duration of "on" time in minutes from a single dose of Sinemet		2 weeks, between visits 2 and 3	No
Secondary	Change in motor function and dyskinesia	Change in motor function and dyskinesia as assessed by 9-hole peg test for upper extremity manipulation/dexterity, Five times sit-to-stand test, comfortable 20 feet gait speed, times up and go test, Movement Disorder Society Unified Parkinson Disease Rating Scale Part 3, Abnormal Involuntary Movement scale, and limb accelerometer data.	2 weeks, between visits 2 and 3	No