- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00223223
Levetiracetam for Neuroprotection Against Corticosteroid-induced Hippocampal Dysfunction: A Proof of Concept Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75235
- The University of Texas Southwestern Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: E. Sherwood Brown, M.D., Ph.D., UT Southwestern Medical Center at Dallas
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 112004-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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