Clinical trial NCT00664209: Treating H. Pylori in Parkinson's Patients With Motor Fluctuations
Official title: Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Parkinson's Disease
Helicobacter Infections
Motor Fluctuations
Keywords: Parkinson's disease
levodopa
Helicobacter pylori
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2008-04-22
Enrollment: 64
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: "Off" Time
timeFrame: 2 months
Secondary outcomes:
measure: Improvement in UPDRS Total Scores
timeFrame: 2 months
measure: Improvement in UDPRS Part III
timeFrame: 2 months
measure: Improvement in Quality of Life as Assessed by PDQ-39
timeFrame: 2 months
measure: Participants With Side Effects From Study Treatment
timeFrame: 2 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Neurology
state: California
Study officials:
affiliation: UCLA Neurology
name: Jeff M Bronstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belhoussine-Idrissi L, Boedeker EC. Helicobacter pylori infection: treatment. Curr Opin Gastroenterol. 2002 Jan;18(1):26-33. doi: 10.1097/00001574-200201000-00005.
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. doi: 10.1212/01.wnl.0000221672.01272.ba.
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. doi: 10.1002/ana.1267. No abstract available.
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. doi: 10.1007/s100720170061.
citation: 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.