N/A N=10 Randomized Double-blind Treatment

Erythromycin in Parkinson's Disease

Parkinson's Disease · Levodopa

Bottom Line

View on ClinicalTrials.gov: NCT02005029 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcome: Primary: Gastric Emptying Time — 105; 180 minutes — p=0.036

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Erythromycin (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Virginia Commonwealth University
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Gastric Emptying Time	105; 180	0.036 sig
PRIMARY Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo	123237; 103584	—
SECONDARY 9-hole Peg Test Right Hand	25.36; 25.80	0.65
SECONDARY 9-hole Peg Test Left Hand	29.36; 27.33	0.18
SECONDARY Five Times Sit-to-stand Test	11.09; 10.09	0.4405
SECONDARY Comfortable 20 Feet Gait Speed (CGS)	4.26; 4.10	0.6011
SECONDARY Timed up and go Test (TUAG) Comfortable Speed	8.67; 8.26	0.8923
SECONDARY Timed up and go Test (TUAG) Fast Speed	6.79; 6.85	0.832
SECONDARY Change in Dyskinesia	0.875; 0.375	0.1546
SECONDARY MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)	30.75; 25.37; 17.13; 16.50	0.0314 sig
SECONDARY Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo	1267; 1395	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02005029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.