Treating H. Pylori in Parkinson's Patients With Motor Fluctuations
Information source: University of California, Los Angeles
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease; Helicobacter Infections; Motor Fluctuations
Intervention: clartihromycin, amoxicillin, and omeprazole (Drug); placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of California, Los Angeles Official(s) and/or principal investigator(s):
Jeff M Bronstein, MD, PhD, Principal Investigator, Affiliation: UCLA Neurology
Overall contact:
Nicholas R Szumski, MD, Phone: 310-206-4144, Email: nszumski@mednet.ucla.edu
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.
Clinical Details
Official title: Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Average total daily "off" time (measured by patient symptom diaries)
Secondary outcome: Improvement in UPDRS total scores ("on" and "off")Improvement in UDPRS Part III (Motor) scores ("on" and "off") Improvement in quality of life measures (using PDQ-39) Side effects profile
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 with Parkinson's disease who have motor fluctuations,
specifically excessive "off" time, when their levodopa is not working to control symptoms.
We seek to identify the frequency of H. pylori infection in this population using standard
lab assays and determine whether eradication with standard triple therapy results in
improved clinical response to medication.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Male.
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.
Locations and Contacts
Nicholas R Szumski, MD, Phone: 310-206-4144, Email: nszumski@mednet.ucla.edu
UCLA Neurology, Los Angeles, California 90095, United States; Recruiting
Additional Information
Related publications: Belhoussine-Idrissi L, Boedeker EC. Helicobacter pylori infection: treatment. Curr Opin Gastroenterol. 2002 Jan;18(1):26-33. Pierantozzi M, Pietroiusti A, Brusa L, Galati S, Stefani A, Lunardi G, Fedele E, Sancesario G, Bernardi G, Bergamaschi A, Magrini A, Stanzione P, Galante A. Helicobacter pylori eradication and l-dopa absorption in patients with PD and motor fluctuations. Neurology. 2006 Jun 27;66(12):1824-9. Pierantozzi M, Pietroiusti A, Galante A, Sancesario G, Lunardi G, Fedele E, Giacomini P, Stanzione P. Helicobacter pylori-induced reduction of acute levodopa absorption in Parkinson's disease patients. Ann Neurol. 2001 Nov;50(5):686-7. No abstract available. Pierantozzi M, Pietroiusti A, Sancesario G, Lunardi G, Fedele E, Giacomini P, Frasca S, Galante A, Marciani MG, Stanzione P. Reduced L-dopa absorption and increased clinical fluctuations in Helicobacter pylori-infected Parkinson's disease patients. Neurol Sci. 2001 Feb;22(1):89-91. Wolle K, Malfertheiner P. Treatment of Helicobacter pylori. Best Pract Res Clin Gastroenterol. 2007;21(2):315-24. Review.
Starting date: January 2008
Last updated: April 21, 2008
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