Treating H. Pylori in Parkinson's Patients With Motor Fluctuations

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: Michael J. Fox Foundation for Parkinson's Research
• Treatments: Amoxicillin; Omeprazole

Criteria

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.