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NCT00591006 · ClinicalTrials.gov registry record · Phase 3
Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes
A Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 17
- Enrollment target
NCT00591006: Completed Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
NCT00591006 is a Phase 3 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 17 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00591006, a Phase 3 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this research is to determine if patients who receive phenytoin (also commonly known as Dilantin) before taking corticosteroids will show less memory impairment and hypomanic symptoms (feelings of agitation, overexcitement or hyperactivity) than those receiving placebo (an inactive substance). This research also seeks to determine if patients taking phenytoin before corticosteroids show more activity in the area of the brain involved with memory than those receiving placebo. This research is being done because increased levels of cortisol (the body's natural corticosteroid) in the body are frequently associated with forgetfulness, and interventions that may prevent or reverse this effect are of great importance.
Primary Outcome
The Rey Auditory Verbal Learning Test (RAVLT) evaluates a wide diversity of functions, including short-term auditory-verbal memory, and retention of information. Test raw scores are converted to T-scores. T-scores have a mean of 30 ± 10 where higher scores are indicative of better verbal memory. Total T-score differences following study treatment interventions are reported.
Interventions
- DRUG Placebo
- DRUG Hydrocortisone
- DRUG Phenytoin (brand name Dilantin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
What the finished NCT00591006 record still lists
NCT00591006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00591006 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00591006 about?
NCT00591006 is a clinical study titled "Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes". The purpose of this research is to determine if patients who receive phenytoin (also commonly known as Dilantin) before taking corticosteroids will show less memory impairment and hypomanic symptoms (feelings of agitation, overexcitement or hyperactivity) than those receiving placebo (an inactive su...
What is the current status of trial NCT00591006?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 17 participants. The study started on 2008-01. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00591006?
The interventions under investigation include: Placebo (DRUG), Hydrocortisone (DRUG), Phenytoin (brand name Dilantin) (DRUG).
Who is sponsoring clinical trial NCT00591006?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00591006's enrollment target sits among peer trials
17 1971st of 2000 higher than 27 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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