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| ID | Type | Description | Link |
|---|---|---|---|
| 441437-JB-58330 |
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Prevalence of H Pylori in the study population was much lower than anticipated
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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active-placebo | Other | These subject receive treatment with active triple therapy followed by treatment with placebo therapy. |
|
| Placebo-active | Other | These subject receive treatment with placebo therapy followed by treatment with active triple therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clartihromycin, amoxicillin, and omeprazole | Drug | clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| "Off" Time | Average total daily "off" time (measured by patient symptom diaries) in hours | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff M Bronstein, MD, PhD | UCLA Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Neurology | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17031226 | Background | Belhoussine-Idrissi L, Boedeker EC. Helicobacter pylori infection: treatment. Curr Opin Gastroenterol. 2002 Jan;18(1):26-33. doi: 10.1097/00001574-200201000-00005. | |
| 16801644 | Background | Pierantozzi M, Pietroiusti A, Brusa L, Galati S, Stefani A, Lunardi G, Fedele E, Sancesario G, Bernardi G, Bergamaschi A, Magrini A, Stanzione P, Galante A. Helicobacter pylori eradication and l-dopa absorption in patients with PD and motor fluctuations. Neurology. 2006 Jun 27;66(12):1824-9. doi: 10.1212/01.wnl.0000221672.01272.ba. |
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Of 64 enrolled, 13 positive for H. Pylori were screened for motor fluctuations (wearing off of the benefits of levodopa).
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Those with significant wearing-off were to be assigned to arms, and received open-label triple eradication therapy (standard of care) per physician decision because the screen yield was too low to test effect size between arms. ---- Clarithromycin 500mg - i PO BID x10 days; Amoxicillin 1gm - i PO BID x10 days; Omeprazole 10mg - i PO BID x10 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Motor Fluctuations Screen |
|
| ||||||||||||||||||
| Study Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | H. Pylori positive participants screened for eligibility to a treatment assignment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | "Off" Time | Average total daily "off" time (measured by patient symptom diaries) in hours | Participants did not return symptom diaries | Posted | 2 months |
|
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | Standard treatment with active triple therapy | 0 |
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Screening yield was much lower than anticipated based on the literature which prohibited completion of the study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Bronstein MD, PhD | UCaliforniaLA | 310 206-9799 | jbronste@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D016481 | Helicobacter Infections |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D009853 | Omeprazole |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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|
| placebo | Drug | placebo therapy |
|
| 2 months |
| 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 | 2 months |
| 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. | 2 months |
| Participants With Side Effects From Study Treatment | Side effects profile | 2 months |
| 11706979 | Background | Pierantozzi M, Pietroiusti A, Galante A, Sancesario G, Lunardi G, Fedele E, Giacomini P, Stanzione P. Helicobacter pylori-induced reduction of acute levodopa absorption in Parkinson's disease patients. Ann Neurol. 2001 Nov;50(5):686-7. doi: 10.1002/ana.1267. No abstract available. |
| 11487216 | Background | Pierantozzi M, Pietroiusti A, Sancesario G, Lunardi G, Fedele E, Giacomini P, Frasca S, Galante A, Marciani MG, Stanzione P. Reduced L-dopa absorption and increased clinical fluctuations in Helicobacter pylori-infected Parkinson's disease patients. Neurol Sci. 2001 Feb;22(1):89-91. doi: 10.1007/s100720170061. |
| 17382279 | Background | Wolle K, Malfertheiner P. Treatment of Helicobacter pylori. Best Pract Res Clin Gastroenterol. 2007;21(2):315-24. doi: 10.1016/j.bpg.2006.11.001. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Subjects H pylori positive with greater than 4 hrs off time/day and completing the UDPRS | Posted | 2 months |
|
|
| 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 | Subjects H pylori positive with greater than 4 hrs off time/day and completing the UDPRS | Posted | 2 months |
|
|
| 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. | Subjects H pylori positive with greater than 4 hrs off time/day and completing the PDQ-29 | Posted | 2 months |
|
|
| Secondary | Participants With Side Effects From Study Treatment | Side effects profile | All subjects receiving H. pylori treatment | Posted | Number | participants | 2 months |
|
|
|
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |