Parkinson's DiseaseNCT02005029

Erythromycin in Parkinson's Disease

A study testing Erythromycin in people with Parkinson's Disease and Levodopa, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Parkinson's Disease, Levodopa
What is being tested?: Erythromycin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Apr 2013to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 21Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University Parkinson's Center
Richmond, Virginia, 23230

Other trials in United States

About this study

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.

Read the detailed 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.

Conditions: Parkinson's Disease, Levodopa
Being tested: Erythromycin, placebo
Keywords: Parkinson's Disease, Levodopa, motor fluctuations, gastroparesis
Medical subject headings: Parkinson Disease, Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ErythromycinDrug
placeboDrug

Study groups in NCT02005029
Study group	Role	What they receive
Placebo	Placebo comparator	One time IV dose of placebo Receives: Drug: placebo
Erythromycin	Experimental	One time IV dose of 100 mg Erythromycin Receives: Drug: Erythromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Gastric Emptying Time
Mean gastric emptying time in minutes as measured by SmartPill
Measured: 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.
Measured: 2 weeks, between visits 2 and 3

Secondary outcomes (9)

9-hole Peg Test Right Hand
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.
Measured: 2 weeks, between visits 2 and 3
9-hole Peg Test Left Hand
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.
Measured: 2 weeks, between visits 2 and 3
Five Times Sit-to-stand Test
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.
Measured: 2 weeks, between visits 2 and 3
Comfortable 20 Feet Gait Speed (CGS)
Change in motor function as assessed by comfortable 20 feet gait speed (CGS)
Measured: 2 weeks, between visits 2 and 3
Timed up and go Test (TUAG) Comfortable Speed
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.
Measured: 2 weeks, between visits 2 and 3
Timed up and go Test (TUAG) Fast Speed
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.
Measured: 2 weeks, between visits 2 and 3
Change in Dyskinesia
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).
Measured: 2 weeks, between visits 2 and 3
MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)
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).
Measured: 2 weeks, between visits 2 and 3
Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo
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.
Measured: 2 weeks, between visits 2 and 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Jun 2015

First posted9 Dec 2013 (estimated)
Study startApr 2013
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02005029
Sponsor's protocol ID: HM15105
Status last verified: Dec 2016
First submitted: 18 Sep 2013
Last updated: 3 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
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A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
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All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Erythromycin in Parkinson's Disease: A Pilot Study of Its Effects on Levodopa Pharmacokinetics and Pharmacodynamics
ClinicalTrials.gov ID: NCT02005029
Acronym / sponsor ID: HM15105
Conditions: Parkinson's Disease, Levodopa
Keywords: Parkinson's Disease, Levodopa, motor fluctuations, gastroparesis
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Study start: Apr 2013
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 9 Dec 2013 (estimated)
Results: Posted 3 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placeboOne time IV dose of placebo
Erythromycin	Experimental	Drug: ErythromycinOne time IV dose of 100 mg Erythromycin

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (21 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Erythromycin	Drug	Erythromycin
placebo	Drug	Placebo

Primary outcome

Gastric Emptying Time
Time frame: 2 weeks, between visits 2 and 3
Mean gastric emptying time in minutes as measured by SmartPill
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.

9 secondary outcomes

9-hole Peg Test Right Hand
Time frame: 2 weeks, between visits 2 and 3
9-hole Peg Test Left Hand
Time frame: 2 weeks, between visits 2 and 3
Five Times Sit-to-stand Test
Time frame: 2 weeks, between visits 2 and 3
Comfortable 20 Feet Gait Speed (CGS)
Time frame: 2 weeks, between visits 2 and 3
Timed up and go Test (TUAG) Comfortable Speed
Time frame: 2 weeks, between visits 2 and 3
Timed up and go Test (TUAG) Fast Speed
Time frame: 2 weeks, between visits 2 and 3
Change in Dyskinesia
Time frame: 2 weeks, between visits 2 and 3
MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)
Time frame: 2 weeks, between visits 2 and 3
Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo
Time frame: 2 weeks, between visits 2 and 3

Results and safety

Results posted to the registry on 3 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo First Then Erythromycin	5	4
Erythromycin Then Placebo	5	5

Primary outcome: Gastric Emptying Time

Time frame: 2 weeks, between visits 2 and 3. Mean (Standard Deviation). Unit: minutes

Measure	Erythromycin n = 4	Placebo n = 4
Value	105 (66.5)	180 (40.6)

Erythromycin vs Placebo: p = 0.036, t-test, 2 sided

Population analysed: Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and four participants were unable to complete a SmartPill evaluation.

Primary outcome: Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo

Time frame: 2 weeks, between visits 2 and 3. Mean (Standard Deviation). Unit: ng/mL*min

Measure	Erythromycin n = 7	Placebo n = 7
Value	123237 (137561)	103584 (106271)

Erythromycin vs Placebo: Erythromycin:Placebo AUC ratio: 1.07

Population analysed: Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and one participant had undetectable plasma levodopa levels through out the study and was thus excluded from the pharmacokinetic analysis.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year, 10 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erythromycin	0 of 9 (0%)	4 of 9 (44.4%)	Not reported
Placebo	0 of 10 (0%)	2 of 10 (20%)	Not reported

Limitations and caveats (from the sponsor): An overall limitation was the small sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Parkinson's Disease

Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
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A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leslie J Cloud, M.D. principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Erythromycin in people with Parkinson's Disease and Levodopa, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastric Emptying Time (time frame: 2 weeks, between visits 2 and 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02005029.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.