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Completed

NCT Number: NCT02005029

Erythromycin in Parkinson's Disease

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Digestive System Diseases Gastrointestinal Diseases Gastroparesis Levodopa Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Paralysis Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University Parkinson's Center

Richmond, Virginia, 23230, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythromycin

Drug

Placebo

Drug

Primary outcomes

  1. Gastric Emptying Time

    Time frame: 2 weeks, between visits 2 and 3

    Mean gastric emptying time in minutes as measured by SmartPill

  2. Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo

    Time frame: 2 weeks, between visits 2 and 3

    Mean Area under the Curve 0-4 hours for plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes.

Secondary outcomes

  1. 9-hole Peg Test Right Hand

    Time frame: 2 weeks, between visits 2 and 3

    Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately.

  2. 9-hole Peg Test Left Hand

    Time frame: 2 weeks, between visits 2 and 3

    Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately.

  3. Five Times Sit-to-stand Test

    Time frame: 2 weeks, between visits 2 and 3

    Change in motor function as measured by Five times sit-to-stand test. This test measures the total time to complete 5 repetitions of sit to stand.

  4. Comfortable 20 Feet Gait Speed (CGS)

    Time frame: 2 weeks, between visits 2 and 3

    Change in motor function as assessed by comfortable 20 feet gait speed (CGS)

  5. Timed up and go Test (TUAG) Comfortable Speed

    Time frame: 2 weeks, between visits 2 and 3

    Change in motor function as assessed by timed up and go test (comfortable speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting.

  6. Timed up and go Test (TUAG) Fast Speed

    Time frame: 2 weeks, between visits 2 and 3

    Change in motor function as assessed by timed up and go test (fast speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting.

  7. Change in Dyskinesia

    Time frame: 2 weeks, between visits 2 and 3

    Mean total AIMS (Abnormal Involuntary Movements Scale) score after receiving erythromycin minus mean total AIMS score after receiving placebo. The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. Ten of the items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Two of the items are not scored. Total score range is from 0 to 40. Higher scores represent more severe dyskinesia (a worse outcome).

  8. MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)

    Time frame: 2 weeks, between visits 2 and 3

    Part 3 of this scale is a standardized physical assessment that quantifies the total burden of motor symptoms in Parkinson's disease patients. Each of the 18 items on the scale is rated from 0 (none, 1 (slight), 2 (mild), 3 (moderate) and 4 (severe). Scores range from 0-72. Higher scores represent a more severe burden of motor symptoms (a worse outcome).

  9. Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo

    Time frame: 2 weeks, between visits 2 and 3

    Mean Cmax of plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2013
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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