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Sponsors and Collaborators: |
University of California, Los Angeles The Michael J. Fox Foundation |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00664209 |
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 |
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 |
Estimated Enrollment: | 100 |
Study Start Date: | January 2008 |
Arms | Assigned Interventions |
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Active-placebo
These subject receive treatment with active triple therapy followed by treatment with placebo therapy.
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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
|
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contact: Nicholas R Szumski, MD | 310-206-4144 | nszumski@mednet.ucla.edu |
United States, California | |
UCLA Neurology | Recruiting |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Jeff M Bronstein, MD, PhD | UCLA Neurology |
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 |
Parkinson's disease levodopa Helicobacter pylori |
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 |
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 |