Parkinson's DiseasePhase 3NCT00664209
Treating H. Pylori in Parkinson's Patients With Motor Fluctuations
A Phase 3 study testing clartihromycin, amoxicillin, and omeprazole in people with Parkinson's Disease and Helicobacter Infections, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Parkinson's Disease, Helicobacter Infections, Motor Fluctuations
- What is being tested?
- clartihromycin, amoxicillin, and omeprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease
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.
Read the 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.
- Being tested
- clartihromycin, amoxicillin, and omeprazole, placebo
- Keywords
- Parkinson's disease, levodopa, Helicobacter pylori
- Medical subject headings
- Parkinson Disease, Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clartihromycin, amoxicillin, and omeprazoleDrug
Also called Biaxin, Prilosec
clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days
placeboDrug
placebo therapy
| Study group | Role | What they receive |
|---|---|---|
| Active-placebo | Other | These subject receive treatment with active triple therapy followed by treatment with placebo therapy. Receives: Drug: clartihromycin, amoxicillin, and omeprazole; Drug: placebo |
| Placebo-active | Other | These subject receive treatment with placebo therapy followed by treatment with active triple therapy. Receives: Drug: clartihromycin, amoxicillin, and omeprazole; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Off" Time
Average total daily "off" time (measured by patient symptom diaries) in hours
Measured: 2 months
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 2 months
Participants With Side Effects From Study Treatment
Side effects profile
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2011
- Study completionJun 2012
Why it stopped: Prevalence of H Pylori in the study population was much lower than anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Jeff Bronstein, University of California, Los Angeles
- Investigators
- Jeff M Bronstein, MD, PhD, Principal investigator, UCLA Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664209
- Sponsor's protocol ID
- MJJF Clinical Discovery 2007
- Other IDs
- 441437-JB-58330
- Status last verified
- Oct 2017
- First submitted
- 21 Apr 2008
- Last updated
- 2 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Belhoussine-Idrissi L, Boedeker EC. Helicobacter pylori infection: treatment. Curr Opin Gastroenterol. 2002 Jan;18(1):26-33. doi: 10.1097/00001574-200201000-00005.
PubMed 17031226Pierantozzi 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.
PubMed 16801644Pierantozzi 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.
PubMed 11706979Pierantozzi 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.
PubMed 11487216Wolle 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.
PubMed 17382279
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00664209
- Acronym / sponsor ID
- MJJF Clinical Discovery 2007
- Keywords
- Parkinson's disease, levodopa, Helicobacter pylori
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Prevalence of H Pylori in the study population was much lower than anticipated
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Jan 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Posted 2 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active-placebo | Other | Drug: clartihromycin, amoxicillin, and omeprazole, Drug: placeboThese subject receive treatment with active triple therapy followed by treatment with placebo therapy. |
| Placebo-active | Other | Drug: clartihromycin, amoxicillin, and omeprazole, Drug: placeboThese subject receive treatment with placebo therapy followed by treatment with active triple therapy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clartihromycin, amoxicillin, and omeprazoleAlso: Biaxin, Prilosecclarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days | Drug | Active-placebo, Placebo-active |
| placeboplacebo therapy | Drug | Active-placebo, Placebo-active |
Primary outcome
"Off" Time
Time frame: 2 months
Average total daily "off" time (measured by patient symptom diaries) in hours
4 secondary outcomes
Improvement in UPDRS Total Scores
Time frame: 2 months
Improvement in UDPRS Part III
Time frame: 2 months
Improvement in Quality of Life as Assessed by PDQ-39
Time frame: 2 months
Participants With Side Effects From Study Treatment
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17031226Belhoussine-Idrissi L, Boedeker EC. Helicobacter pylori infection: treatment. Curr Opin Gastroenterol. 2002 Jan;18(1):26-33. doi: 10.1097/00001574-200201000-00005.
- Background: PubMed 16801644Pierantozzi 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.
- Background: PubMed 11706979Pierantozzi 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.
- Background: PubMed 11487216Pierantozzi 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.
- Background: PubMed 17382279Wolle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff M Bronstein, MD, PhD principal investigator
UCLA Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clartihromycin, amoxicillin, and omeprazole in people with Parkinson's Disease and Helicobacter Infections, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Off" Time (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00664209, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.