Treating H. Pylori in Parkinson's Patients With Motor Fluctuations - Full Text View

Sponsors and Collaborators:	University of California, Los Angeles The Michael J. Fox Foundation
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00664209

Purpose

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 III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Clarithromycin Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Levodopa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease

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

Primary Outcome Measures:

Average total daily "off" time (measured by patient symptom diaries) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement in UPDRS total scores ("on" and "off") [ Designated as safety issue: No ]
Improvement in UDPRS Part III (Motor) scores ("on" and "off") [ Designated as safety issue: No ]
Improvement in quality of life measures (using PDQ-39)
Side effects profile [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	January 2008

Arms	Assigned Interventions
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 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 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.

Eligibility

Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664209

Contacts

Contact: Nicholas R Szumski, MD

310-206-4144

nszumski@mednet.ucla.edu

Locations

United States, California
UCLA Neurology	Recruiting
Los Angeles, California, United States, 90095

Sponsors and Collaborators

University of California, Los Angeles

The Michael J. Fox Foundation

Investigators

Principal Investigator:

Jeff M Bronstein, MD, PhD

UCLA Neurology

More Information

Publications:

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

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.

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. No abstract available.

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.

Wolle K, Malfertheiner P. Treatment of Helicobacter pylori. Best Pract Res Clin Gastroenterol. 2007;21(2):315-24. Review.

Responsible Party:	UCLA Neurology ( Jeff Bronstein, MD, PhD )
Study ID Numbers:	MJJF Clinical Discovery 2007, 441437-JB-58330
Study First Received:	April 21, 2008
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00664209
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:

Parkinson's disease
levodopa
Helicobacter pylori

Study placed in the following topic categories:

Bacterial Infections
Levodopa
Amoxicillin
Ganglion Cysts
Basal Ganglia Diseases
Omeprazole
Central Nervous System Diseases
Helicobacter Infections

Brain Diseases
Neurodegenerative Diseases
Gram-Negative Bacterial Infections
Clarithromycin
Parkinson Disease
Movement Disorders
Parkinsonian Disorders

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Nervous System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009