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

University of California, Los Angeles (UCLA)

Status and phase: Terminated; Phase 3

Conditions: Helicobacter Infections; Parkinson's Disease; Motor Fluctuations

Treatments: Drug: placebo; Drug: clartihromycin, amoxicillin, and omeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00664209

441437-JB-58330

MJJF Clinical Discovery 2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Male

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

Active-placebo

Other group

Description:

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

Treatment:

Drug: clartihromycin, amoxicillin, and omeprazole

Drug: placebo

Placebo-active

Other group

Description:

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

Treatment:

Drug: clartihromycin, amoxicillin, and omeprazole

Drug: placebo