Parkinson's Disease Clinical Trial
Official title:
Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease
Verified date | October 2017 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 64 |
Est. completion date | June 2012 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | UCLA Neurology | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | Michael J. Fox Foundation for Parkinson's Research |
United States,
Belhoussine-Idrissi L, Boedeker EC. Helicobacter pylori infection: treatment. Curr Opin Gastroenterol. 2002 Jan;18(1):26-33. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Wolle K, Malfertheiner P. Treatment of Helicobacter pylori. Best Pract Res Clin Gastroenterol. 2007;21(2):315-24. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | "Off" Time | Average total daily "off" time (measured by patient symptom diaries) in hours | 2 months | |
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. | 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 | 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. | 2 months | |
Secondary | Participants With Side Effects From Study Treatment | Side effects profile | 2 months |
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