Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- "Off" Time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Active-placebo
These subject receive treatment with active triple therapy followed by treatment with placebo therapy.
Intervention: clartihromycin, amoxicillin, and omeprazole (Drug)
Active-placebo
These subject receive treatment with active triple therapy followed by treatment with placebo therapy.
Intervention: placebo (Drug)
Placebo-active
These subject receive treatment with placebo therapy followed by treatment with active triple therapy.
Intervention: clartihromycin, amoxicillin, and omeprazole (Drug)
Placebo-active
These subject receive treatment with placebo therapy followed by treatment with active triple therapy.
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
"Off" Time
Time Frame: 2 months
Average total daily "off" time (measured by patient symptom diaries) in hours
Secondary Outcomes
- Improvement in UDPRS Part III(2 months)
- Improvement in UPDRS Total Scores(2 months)
- Improvement in Quality of Life as Assessed by PDQ-39(2 months)
- Participants With Side Effects From Study Treatment(2 months)
Investigators
Jeff Bronstein
Professor of Neurology
University of California, Los Angeles