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

NCT ID: NCT00664209

Last Updated: 2017-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease Helicobacter Infections Motor Fluctuations

Keywords

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Parkinson's disease levodopa Helicobacter pylori

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active-placebo

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

Group Type OTHER

clartihromycin, amoxicillin, and omeprazole

Intervention Type DRUG

clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days

placebo

Intervention Type DRUG

placebo therapy

Placebo-active

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

Group Type OTHER

clartihromycin, amoxicillin, and omeprazole

Intervention Type DRUG

clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days

placebo

Intervention Type DRUG

placebo therapy

Interventions

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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

Intervention Type DRUG

placebo

placebo therapy

Intervention Type DRUG

Other Intervention Names

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Biaxin, Prilosec

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Jeff Bronstein

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeff M Bronstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UCLA Neurology

Locations

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UCLA Neurology

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Belhoussine-Idrissi L, Boedeker EC. Helicobacter pylori infection: treatment. Curr Opin Gastroenterol. 2002 Jan;18(1):26-33. doi: 10.1097/00001574-200201000-00005.

Reference Type BACKGROUND
PMID: 17031226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16801644 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11706979 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11487216 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17382279 (View on PubMed)

Other Identifiers

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441437-JB-58330

Identifier Type: -

Identifier Source: secondary_id

MJJF Clinical Discovery 2007

Identifier Type: -

Identifier Source: org_study_id