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Clinical Trials/NCT00223223
NCT00223223
Completed
Phase 4

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

University of Texas Southwestern Medical Center1 site in 1 country30 target enrollmentFebruary 2005

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Memory Loss Associated With Corticosteroid Use
Sponsor
University of Texas Southwestern Medical Center
Enrollment
30
Locations
1
Status
Completed
Last Updated
14 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 2005
End Date
November 2005
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

  • 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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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