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

Primary Purpose

Parkinson's Disease, Helicobacter Infections, Motor Fluctuations

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
clartihromycin, amoxicillin, and omeprazole
placebo
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, levodopa, Helicobacter pylori

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Active-placebo

Placebo-active

Arm Description

These subject receive treatment with active triple therapy followed by treatment with placebo therapy.

These subject receive treatment with placebo therapy followed by treatment with active triple therapy.

Outcomes

Primary Outcome Measures

"Off" Time
Average total daily "off" time (measured by patient symptom diaries) in hours

Secondary Outcome Measures

Improvement in UPDRS Total Scores
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.
Improvement in UDPRS Part III
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
Improvement in Quality of Life as Assessed by PDQ-39
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.
Participants With Side Effects From Study Treatment
Side effects profile

Full Information

First Posted
April 21, 2008
Last Updated
October 31, 2017
Sponsor
University of California, Los Angeles
Collaborators
Michael J. Fox Foundation for Parkinson's Research
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1. Study Identification

Unique Protocol Identification Number
NCT00664209
Brief Title
Treating H. Pylori in Parkinson's Patients With Motor Fluctuations
Official Title
Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Prevalence of H Pylori in the study population was much lower than anticipated
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Michael J. Fox Foundation for Parkinson's Research

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Helicobacter Infections, Motor Fluctuations
Keywords
Parkinson's disease, levodopa, Helicobacter pylori

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active-placebo
Arm Type
Other
Arm Description
These subject receive treatment with active triple therapy followed by treatment with placebo therapy.
Arm Title
Placebo-active
Arm Type
Other
Arm Description
These subject receive treatment with placebo therapy followed by treatment with active triple therapy.
Intervention Type
Drug
Intervention Name(s)
clartihromycin, amoxicillin, and omeprazole
Other Intervention Name(s)
Biaxin, Prilosec
Intervention Description
clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo therapy
Primary Outcome Measure Information:
Title
"Off" Time
Description
Average total daily "off" time (measured by patient symptom diaries) in hours
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Improvement in UPDRS Total Scores
Description
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.
Time Frame
2 months
Title
Improvement in UDPRS Part III
Description
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
Time Frame
2 months
Title
Improvement in Quality of Life as Assessed by PDQ-39
Description
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.
Time Frame
2 months
Title
Participants With Side Effects From Study Treatment
Description
Side effects profile
Time Frame
2 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff M Bronstein, MD, PhD
Organizational Affiliation
UCLA Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Neurology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17031226
Citation
Belhoussine-Idrissi L, Boedeker EC. Helicobacter pylori infection: treatment. Curr Opin Gastroenterol. 2002 Jan;18(1):26-33. doi: 10.1097/00001574-200201000-00005.
Results Reference
background
PubMed Identifier
16801644
Citation
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. doi: 10.1212/01.wnl.0000221672.01272.ba.
Results Reference
background
PubMed Identifier
11706979
Citation
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. doi: 10.1002/ana.1267. No abstract available.
Results Reference
background
PubMed Identifier
11487216
Citation
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. doi: 10.1007/s100720170061.
Results Reference
background
PubMed Identifier
17382279
Citation
Wolle K, Malfertheiner P. Treatment of Helicobacter pylori. Best Pract Res Clin Gastroenterol. 2007;21(2):315-24. doi: 10.1016/j.bpg.2006.11.001.
Results Reference
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Treating H. Pylori in Parkinson's Patients With Motor Fluctuations

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