Status:
TERMINATED
Treating H. Pylori in Parkinson's Patients With Motor Fluctuations
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Parkinson's Disease
Helicobacter Infections
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether treatment of H. pylori (an infection of the stomach) improves treatment effectiveness in patients with Parkinson's disease and motor fluctuations.
Detailed Description
Previous investigations have demonstrated that treatment of Helicobacter pylori with antibiotics leads to improved absorption and pharmacokinetics of levodopa. This may potentially benefit patients wi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adults diagnosed with idiopathic Parkinson's disease, Hoehn \& Yahr stage 2-4 in the "off" state, with no other concomitant neurologic diseases.
- Stable (≥30 days) Parkinson's disease therapy, with demonstrable medication efficacy, but with wearing off phenomenon present between levodopa doses (average off time ≥3 hours off time/day).
- Levodopa therapy required; Any formulation (e.g. Sinemet, Sinemet CR, Stalevo) is acceptable. Parkinson's disease treatment may also include any of the following medications or classes: non-ergot dopamine agonists, COMT inhibitors, MAO-B inhibitors, amantadine, anticholinergics.
- Positive for H. pylori IgG Ab by serum ELISA (before inclusion in randomized treatment arms).
- Exclusion criteria:
- Current abdominal pain, unexplained nausea/vomiting, or gastrointestinal bleeding.
- History of gastric cancer, peptic ulcer, duodenal ulcer, or other gastric or duodenal lesions.
- History of previous gastric surgery.
- History of previous brain surgery for Parkinson's disease.
- Family history of gastric cancer.
- Prior treatment for H. pylori+ status.
- Recent use (previous 4 weeks) of proton-pump inhibitor, amoxicillin, or clarithromycin.
- Allergy or sensitivity to penicillin, amoxicillin, clarithromycin, or omeprazole.
- Use of drugs affecting gastric motility (e.g. domperidone, metoclopramide).
- Inability to tolerate or participate in testing in the morning in an "off" state.
- Inability to communicate effectively with study personnel in English.
- Pregnancy.
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00664209
Start Date
January 1 2008
End Date
June 1 2012
Last Update
December 2 2017
Active Locations (1)
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1
UCLA Neurology
Los Angeles, California, United States, 90095