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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: Completed Phase 1 study, sponsored by University of Minnesota.
NCT02967250 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
measurement of ATP concentrations in brain using 7T MRS
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 |
What the finished NCT02967250 record still lists
NCT02967250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which ursodeoxycholic acid is the first listed.
NCT02967250 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02967250's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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