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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by University of California, Los Angeles.
Recruitment status was:  Recruiting
Michael J. Fox Foundation for Parkinson's Research
Information provided by:
University of California, Los Angeles Identifier:
First received: April 21, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
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.

Condition Intervention Phase
Parkinson's Disease
Helicobacter Infections
Motor Fluctuations
Drug: clartihromycin, amoxicillin, and omeprazole
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease

Resource links provided by NLM:

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Average total daily "off" time (measured by patient symptom diaries)

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: January 2008
Arms Assigned Interventions
These subject receive treatment with active triple therapy followed by treatment with placebo therapy.
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
Other Name: Biaxin, Prilosec
Drug: placebo
placebo therapy
These subject receive treatment with placebo therapy followed by treatment with active triple therapy.
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
Other Name: Biaxin, Prilosec
Drug: placebo
placebo therapy

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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00664209

Contact: Nicholas R Szumski, MD 310-206-4144

United States, California
UCLA Neurology Recruiting
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Michael J. Fox Foundation for Parkinson's Research
Principal Investigator: Jeff M Bronstein, MD, PhD UCLA Neurology
  More Information

Responsible Party: Jeff Bronstein, MD, PhD, UCLA Neurology Identifier: NCT00664209     History of Changes
Other Study ID Numbers: MJJF Clinical Discovery 2007
Study First Received: April 21, 2008
Last Updated: April 21, 2008

Keywords provided by University of California, Los Angeles:
Parkinson's disease
Helicobacter pylori

Additional relevant MeSH terms:
Parkinson Disease
Helicobacter Infections
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 25, 2017