Official Title: “Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: clartihromycin, amoxicillin, and omeprazole
  • clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days
• Drug: placebo
  • placebo therapy

Arms, Groups and Cohorts in this Clinical Trial

• Other: Active-placebo
  • These subject receive treatment with active triple therapy followed by treatment with placebo therapy.
• Other: Placebo-active
  • These subject receive treatment with placebo therapy followed by treatment with active triple therapy.

Primary Measures

• Average total daily "off" time (measured by patient symptom diaries)
  • Safety Issue?: No

Secondary Measures

• Improvement in UPDRS total scores ("on" and "off")
  • Safety Issue?: No
• Improvement in UDPRS Part III (Motor) scores ("on" and "off")
  • Safety Issue?: No
• Improvement in quality of life measures (using PDQ-39)
• Side effects profile
  • Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of California, Los Angeles

Overall Clinical Trial Officials and Contacts

Jeff M Bronstein, MD, PhD Principal Investigator UCLA Neurology  

Overall Contact: Nicholas R Szumski, MD 310-206-4144 nszumski@mednet.ucla.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00664209

Study ID Number: MJJF Clinical Discovery 2007

ClinicalTrials.gov Identifier: NCT00664209

Health Authority: United States: Institutional Review Board