Erythromycin in Parkinson's Disease
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | April 2013 |
| End Date: | June 2015 |
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.
(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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
