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NCT02967250 · ClinicalTrials.gov registry record · Phase 1
Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT02967250 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 5 participants.
The verdict
NCT02967250, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The objective of this study is to understand the bioenergetic impairments that underlie Parkinson's disease (PD) and evaluating treatments that may improve abnormal mitochondrial function that is present in PD. The hypothesis is that repeated oral dosing of UDCA will result in increased brain ATP levels in individuals with Parkinson's disease (PD). The specific aims are 1.) to measure plasma UDCA levels in individuals with PD at baseline and after four weeks of repeated high doses of oral UDCA (50mg/kg/day) and 2.) to measure cortical bioenergetic profile and ATPase activity (as ascertained through MRS) in those with PD at baseline and at four weeks after repeated high doses of oral UDCA (50mg/kg/day) simultaneously. Secondary aims are to characterize oral UDCA pharmacokinetics and develop a pharmacokinetic/pharmacodynamic model to characterize the relationship between peripheral measurements of UDCA (and associated conjugates) and peripheral measures and/or central (brain) bioenergetic measurements.
Interventions
- DRUG ursodeoxycholic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-04-01 |
| Est. Completion | 2022-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02967250
The ClinicalTrials.gov registry entry for NCT02967250 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ursodeoxycholic acid is the first listed.
NCT02967250 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02967250 about?
NCT02967250 is a clinical study titled "Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment". The objective of this study is to understand the bioenergetic impairments that underlie Parkinson's disease (PD) and evaluating treatments that may improve abnormal mitochondrial function that is present in PD. The hypothesis is that repeated oral dosing of UDCA will result in increased brain ATP le...
What is the current status of trial NCT02967250?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2020-04-01. Estimated completion is 2022-02-28.
What interventions are being tested in trial NCT02967250?
The interventions under investigation include: ursodeoxycholic acid (DRUG).
Who is sponsoring clinical trial NCT02967250?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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