Parkinson's Disease Clinical Trial
Official title:
Erythromycin in Parkinson's Disease: A Pilot Study of Its Effects on Levodopa Pharmacokinetics and Pharmacodynamics
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University Parkinson's Center | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
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 |
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