Erythromycin in Parkinson's Disease

NCT02005029 | Completed Results DMC

• 1 other identifier: HM15105
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Levodopa

Keywords

Parkinson's Disease; Levodopa; motor fluctuations; gastroparesis

Outcome Measures

Primary Outcomes (2)

• Gastric Emptying Time

  Mean gastric emptying time in minutes as measured by SmartPill

  2 weeks, between visits 2 and 3

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

  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.

  2 weeks, between visits 2 and 3

Secondary Outcomes (9)

• 9-hole Peg Test Right Hand

  2 weeks, between visits 2 and 3

• 9-hole Peg Test Left Hand

  2 weeks, between visits 2 and 3

• Five Times Sit-to-stand Test

  2 weeks, between visits 2 and 3

• Comfortable 20 Feet Gait Speed (CGS)

  2 weeks, between visits 2 and 3

• Timed up and go Test (TUAG) Comfortable Speed

  2 weeks, between visits 2 and 3

Study Arms (2)

Placebo

PLACEBO COMPARATOR

One time IV dose of placebo

Drug: placebo

Erythromycin

EXPERIMENTAL

One time IV dose of 100 mg Erythromycin

Drug: Erythromycin

Interventions

Erythromycin DRUG

Erythromycin

placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University Parkinson's Center

Richmond, Virginia, 23230, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Gastroparesis

Interventions

Erythromycin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Limitations and Caveats

An overall limitation was the small sample size.

Results Point of Contact

• Title: Dr. Leslie Cloud
• Organization: Virginia Commonwealth University

leslie.cloud@vcuhealth.org

804-662-5304

Study Officials

• Leslie J Cloud, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: December 9, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 3, 2017
• Results First Posted: February 3, 2017

Record last verified: 2016-12

Locations

US (1)