Clinical trial NCT02005029: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Levodopa
Keywords: Parkinson's Disease
Levodopa
motor fluctuations
gastroparesis
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gastric Emptying Time
timeFrame: 2 weeks, between visits 2 and 3
measure: Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo
timeFrame: 2 weeks, between visits 2 and 3
Secondary outcomes:
measure: 9-hole Peg Test Right Hand
timeFrame: 2 weeks, between visits 2 and 3
measure: 9-hole Peg Test Left Hand
timeFrame: 2 weeks, between visits 2 and 3
measure: Five Times Sit-to-stand Test
timeFrame: 2 weeks, between visits 2 and 3
measure: Comfortable 20 Feet Gait Speed (CGS)
timeFrame: 2 weeks, between visits 2 and 3
measure: Timed up and go Test (TUAG) Comfortable Speed
timeFrame: 2 weeks, between visits 2 and 3
measure: Timed up and go Test (TUAG) Fast Speed
timeFrame: 2 weeks, between visits 2 and 3
measure: Change in Dyskinesia
timeFrame: 2 weeks, between visits 2 and 3
measure: MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)
timeFrame: 2 weeks, between visits 2 and 3
measure: Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo
timeFrame: 2 weeks, between visits 2 and 3
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Parkinson's Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Leslie J Cloud, M.D.
role: PRINCIPAL_INVESTIGATOR
References: