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

Parkinson's Disease Clinical Trial

Official title:

Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00664209
• Other study ID #: MJJF Clinical Discovery 2007
• Secondary ID: 441437-JB-58330
• Status: Terminated
• Phase: Phase 3
• First received: April 21, 2008
• Last updated: October 31, 2017
• Start date: January 2008
• Est. completion date: June 2012

Study information

• Verified date: October 2017
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Helicobacter Infections
• Motor Fluctuations
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• clartihromycin, amoxicillin, and omeprazole
clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days
• placebo
placebo therapy

Locations

Country	Name	City	State
United States	UCLA Neurology	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

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