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

NCT00664209 | Terminated Phase 3 Results

• 2 other identifiers: MJJF Clinical Discovery 2007441437-JB-58330
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Helicobacter Infections; Motor Fluctuations

Keywords

Parkinson's disease; levodopa; Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

• "Off" Time

  Average total daily "off" time (measured by patient symptom diaries) in hours

  2 months

Secondary Outcomes (4)

• Improvement in UPDRS Total Scores

  2 months

• Improvement in UDPRS Part III

  2 months

• Improvement in Quality of Life as Assessed by PDQ-39

  2 months

• Participants With Side Effects From Study Treatment

  2 months

Study Arms (2)

Active-placebo

OTHER

These subject receive treatment with active triple therapy followed by treatment with placebo therapy.

Drug: clartihromycin, amoxicillin, and omeprazole; Drug: placebo

Placebo-active

OTHER

These subject receive treatment with placebo therapy followed by treatment with active triple therapy.

Drug: clartihromycin, amoxicillin, and omeprazole; Drug: placebo

Interventions

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

Also known as: Biaxin, Prilosec

Active-placebo; Placebo-active

placebo DRUG

placebo therapy

Active-placebo; Placebo-active

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

UCLA Neurology

Los Angeles, California, 90095, United States

Location

Related Publications (5)

• Belhoussine-Idrissi L, Boedeker EC. Helicobacter pylori infection: treatment. Curr Opin Gastroenterol. 2002 Jan;18(1):26-33. doi: 10.1097/00001574-200201000-00005.

  PMID: 17031226 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.

  PMID: 16801644 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.

  PMID: 11706979 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.

  PMID: 11487216 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.

  PMID: 17382279 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Helicobacter Infections

Interventions

Amoxicillin; Omeprazole; Clarithromycin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Erythromycin; Macrolides; Polyketides; Lactones

Limitations and Caveats

Screening yield was much lower than anticipated based on the literature which prohibited completion of the study

Results Point of Contact

• Title: Jeff Bronstein MD, PhD
• Organization: UCaliforniaLA

jbronste@mednet.ucla.edu

310 206-9799

Study Officials

• Jeff M Bronstein, MD, PhD

  UCLA Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 22, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2012
• Last Updated: December 2, 2017
• Results First Posted: December 2, 2017

Record last verified: 2017-10

Locations

US (1)