Ignite Creation Date:
2024-05-06 @ 2:41 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02108704
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2014-04-04
Brief Title:
Helicobacter Pylori Eradication Study in Parkinsons Disease
Sponsor:
University of Malaya
Organization:
University of Malaya
Study Overview
Official Title:
Helicobacter Pylori Eradication in Parkinsons Disease A Double-blind Randomised Placebo Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It has been hypothesized based on epidemiological observations that Helicobacter pylori HP infection may play a role in the pathogenesis of Parkinsons Disease PD Previous studies have also shown that HP eradication therapy may result in improvements in levodopa pharmacokinetics and motor fluctuations This study aims to examine the effects of HP eradication using a double-blind randomized placebo-controlled trial design in a relatively large cohort of patients Outcomes of interest include motor function gastrointestinal symptoms and health-related quality of life The investigators hypothesize that HP eradication will lead to improvements in motor function The primary outcome of interest is the ON-medication Unified PD Rating Scale UPDRS Part III score at 3 months Secondary outcomes include Purdue Pegboard Score Timed Test of Gait Dyskinesia and Bradykinesia scores measured by Parkinsons Kinetigraph PKG Leeds Dyspepsia Questionnaire LDQ Parkinsons Disease Questionnaire PDQ-39 UPDRS Part I Part II and Part IV and Montreal Cognitive Assessment MOCA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None