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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02005029
Other study ID # HM15105
Secondary ID
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


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
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