Treating H. Pylori in Parkinson's Patients With Motor Fluctuations
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Parkinson's Disease, Helicobacter Infections, Motor Fluctuations
In brief
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.
Key facts
- Study ID
- NCT00664209
- Run by
- University of California, Los Angeles
- People needed
- 64
- Starts
- 2008-01-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2017-12-02
Who can join
Age: any. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- UCLA Neurology — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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