Helicobacter Infections, Motor Fluctuations, Parkinson's Disease
Conditions
Keywords
Parkinson's disease, levodopa, Helicobacter pylori
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.
Interventions
DRUGclartihromycin, amoxicillin, and omeprazole
clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days
DRUGplacebo
placebo therapy
Sponsors
Michael J. Fox Foundation for Parkinson's Research
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Off Time | 2 months | Average total daily off time (measured by patient symptom diaries) in hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Countries
United States
Participant flow
Pre-assignment details
Of 64 enrolled, 13 positive for H. Pylori were screened for motor fluctuations (wearing off of the benefits of levodopa).
Participants by arm
| Arm | Count |
|---|---|
| Active H. Pylori positive participants screened for eligibility to a treatment assignment. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Motor Fluctuations Screen | Negative for motor fluctuation | 7 |
| Study Treatment Period | Physician Decision | 4 |
| Study Treatment Period | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Active |
|---|---|
| Age, Continuous | 62.4 years |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Off Time
Average total daily off time (measured by patient symptom diaries) in hours
Time frame: 2 months
Population: Participants did not return symptom diaries
Secondary
Improvement in Quality of Life as Assessed by PDQ-39
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.
Time frame: 2 months
Population: Subjects H pylori positive with greater than 4 hrs off time/day and completing the PDQ-29
Secondary
Improvement in UDPRS Part III
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
Time frame: 2 months
Population: Subjects H pylori positive with greater than 4 hrs off time/day and completing the UDPRS
Secondary
Improvement in UPDRS Total Scores
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.
Time frame: 2 months
Population: Subjects H pylori positive with greater than 4 hrs off time/day and completing the UDPRS
Secondary
Participants With Side Effects From Study Treatment
Side effects profile
Time frame: 2 months
Population: All subjects receiving H. pylori treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active | Participants With Side Effects From Study Treatment | 0 participants |