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

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ClinicalTrials.gov Identifier: NCT00664209
Recruitment Status : Terminated (Prevalence of H Pylori in the study population was much lower than anticipated)
First Posted : April 22, 2008
Results First Posted : December 1, 2017
Last Update Posted : December 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease
Study Start Date : January 2008
Primary Completion Date : June 2011
Study Completion Date : June 2012

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active-placebo
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
Placebo-active
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


Outcome Measures

Primary Outcome Measures :
  1. "Off" Time [ Time Frame: 2 months ]
    Average total daily "off" time (measured by patient symptom diaries) in hours


Secondary Outcome Measures :
  1. Improvement in UPDRS Total Scores [ Time Frame: 2 months ]
    The Unified Parkinson Disease Rating Scale (UPDRS) is a rating tool to follow the longitudinal course of Parkinson's Disease. It is made up of the 1) Mentation, Behavior, and Mood, 2) ADL and 3) Motor sections. These are evaluated by interview. Some sections require multiple grades assigned to each extremity. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability.

  2. Improvement in UDPRS Part III [ Time Frame: 2 months ]
    Improvement in UDPRS Part III (Motor) scores ("on" and "off") UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement

  3. Improvement in Quality of Life as Assessed by PDQ-39 [ Time Frame: 2 months ]
    The Parkinson's Disease Questionnaire (PDQ)-39 contains 39 questions addressing how often patients have experienced difficulties due to having PD in the preceding month. Items are scored from 0 (never) to 4 (always). Lower scores indicate better quality of life.

  4. Participants With Side Effects From Study Treatment [ Time Frame: 2 months ]
    Side effects profile


Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664209


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

Publications:
Responsible Party: Jeff Bronstein, Professor of Neurology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00664209     History of Changes
Other Study ID Numbers: MJJF Clinical Discovery 2007
441437-JB-58330
First Posted: April 22, 2008    Key Record Dates
Results First Posted: December 1, 2017
Last Update Posted: December 1, 2017
Last Verified: October 2017

Keywords provided by Jeff Bronstein, University of California, Los Angeles:
Parkinson's disease
levodopa
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
Amoxicillin
Omeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action