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

Phase 3

Terminated

• Conditions: Motor Fluctuations; Helicobacter Infections; Parkinson's Disease
• Interventions: Drug: clartihromycin, amoxicillin, and omeprazole; Drug: placebo

• Registration Number: NCT00664209
• Lead Sponsor: University of California, Los Angeles

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-22
• Primary Completion: 2011-06
• Study Completion: 2012-06
• Status Verified: 2017-10
• Results First Submitted: 2017-10-31
• Results First Submitted QC: 2017-10-31
• Last Update Submitted: 2017-10-31
• Results First Posted: 2017-12-02
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo-active	clartihromycin, amoxicillin, and omeprazole	These subject receive treatment with placebo therapy followed by treatment with active triple therapy.
Placebo-active	placebo	These subject receive treatment with placebo therapy followed by treatment with active triple therapy.
Active-placebo	clartihromycin, amoxicillin, and omeprazole	These subject receive treatment with active triple therapy followed by treatment with placebo therapy.
Active-placebo	placebo	These subject receive treatment with active triple therapy followed by treatment with placebo therapy.

Primary Outcome Measures

Name	Time	Method
"Off" Time	2 months	Average total daily "off" time (measured by patient symptom diaries) in hours

Secondary Outcome Measures

Name	Time	Method
Improvement in UDPRS Part III	2 months	Improvement in UDPRS Part III (Motor) scores ("on" and "off") UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement
Improvement in UPDRS Total Scores	2 months	The Unified Parkinson Disease Rating Scale (UPDRS) is a rating tool to follow the longitudinal course of Parkinson's Disease. It is made up of the 1) Mentation, Behavior, and Mood, 2) ADL and 3) Motor sections. These are evaluated by interview. Some sections require multiple grades assigned to each extremity. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability.
Improvement in Quality of Life as Assessed by PDQ-39	2 months	The Parkinson's Disease Questionnaire (PDQ)-39 contains 39 questions addressing how often patients have experienced difficulties due to having PD in the preceding month. Items are scored from 0 (never) to 4 (always). Lower scores indicate better quality of life.
Participants With Side Effects From Study Treatment	2 months	Side effects profile

Trial Locations

Locations (1)

UCLA Neurology; 🇺🇸 Los Angeles, California, United States