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CompletedNCT00223223Updated Aug 3, 2011

Levetiracetam for Neuroprotection Against Corticosteroid-induced Hippocampal Dysfunction: A Proof of Concept Study

A Phase 4 interventional study of Levetiracetam, Keppra in Memory Loss Associated With Corticosteroid Use and Manic State Associated With Corticosteroid Use, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-08-03.

Sponsored by University of Texas Southwestern Medical Center · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this research is to determine whether the memory impairment and manic symptoms (feelings of agitation, overexcitement or hyperactivity) typically seen in those on corticosteroid therapy is decreased with a seizure medication called levetiracetam compared to placebo (an inactive substance). Since increased levels of cortisol (the body's natural corticosteroid) in the body are frequently associated with memory impairment interventions that may prevent or reverse this are of great importance.

It is hypothesized that patients who are scheduled to receive prescription corticosteroid therapy who are given levetiracetam pretreatment will show lesser memory impairment and manic symptoms than those receiving placebo.

02

Conditions studied

  • Memory Loss Associated With Corticosteroid Use
  • Manic State Associated With Corticosteroid Use
03

In context

Memory Disorders

260 studies on the registry are indexed under Memory Disorders; 60 are open to participants now.

This study's enrollment of 30 is below the median of 73 across 207 interventional studies indexed under Memory Disorders.

Browse Memory Disorders studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18-65 years
  • Scheduled to receive a corticosteroid "burst" of at least 10 mg of prednisone equivalents and for at least 5 days duration
  • English- or Spanish-speaking

Exclusion criteria

Exclusion Criteria:

  • History of allergic reaction or other contraindication to levetiracetam therapy
  • Other unstable medical conditions (e.g. recent myocardial infarction, renal failure, diabetes with poor glycemic control)
  • Pregnant or nursing women
  • History of mental retardation, dementia or other severe cognitive disorders
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
30 participants

Interventions

  • DrugLevetiracetam, Keppra
06

Study locations

1 site
  • The University of Texas Southwestern Medical Center
    Dallas, Texas 75235, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00223223
Lead sponsor
University of Texas Southwestern Medical Center
Collaborators
UCB Pharma
First posted
Sep 22, 2005
Start date
Feb 2005
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Aug 3, 2011

Study contacts

E. Sherwood Brown, M.D., Ph.D.
principal investigator · UT Southwestern Medical Center at Dallas
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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