Trial Outcomes & Findings for Treating H. Pylori in Parkinson's Patients With Motor Fluctuations (NCT NCT00664209)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

64 participants

Primary outcome timeframe

2 months

Results posted on

2017-12-02

Participant Flow

Of 64 enrolled, 13 positive for H. Pylori were screened for motor fluctuations (wearing off of the benefits of levodopa).

Participant milestones

Participant milestones
Measure	Active Those with significant wearing-off were to be assigned to arms, and received open-label triple eradication therapy (standard of care) per physician decision because the screen yield was too low to test effect size between arms. \---- Clarithromycin 500mg - i PO BID x10 days; Amoxicillin 1gm - i PO BID x10 days; Omeprazole 10mg - i PO BID x10 days
Motor Fluctuations Screen STARTED	13
Motor Fluctuations Screen COMPLETED	6
Motor Fluctuations Screen NOT COMPLETED	7
Study Treatment Period STARTED	6
Study Treatment Period COMPLETED	0
Study Treatment Period NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Those with significant wearing-off were to be assigned to arms, and received open-label triple eradication therapy (standard of care) per physician decision because the screen yield was too low to test effect size between arms. \---- Clarithromycin 500mg - i PO BID x10 days; Amoxicillin 1gm - i PO BID x10 days; Omeprazole 10mg - i PO BID x10 days
Motor Fluctuations Screen Negative for motor fluctuation	7
Study Treatment Period Physician Decision	4
Study Treatment Period Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=13 Participants H. Pylori positive participants screened for eligibility to a treatment assignment.
Age, Continuous	62.4 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Participants did not return symptom diaries

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 months

Population: Subjects H pylori positive with greater than 4 hrs off time/day and completing the UDPRS

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 months

Population: Subjects H pylori positive with greater than 4 hrs off time/day and completing the UDPRS

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 months

Population: Subjects H pylori positive with greater than 4 hrs off time/day and completing the PDQ-29

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 months

Population: All subjects receiving H. pylori treatment

Side effects profile

Outcome measures

Outcome measures
Measure	Active n=6 Participants Standard treatment with active triple therapy
Participants With Side Effects From Study Treatment	0 participants

Adverse Events

Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeff Bronstein MD, PhD

UCaliforniaLA

Phone: 310 206-9799

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place