Back to resultsLevetiracetam for Neuroprotection Against Corticosteroid-induced Hippocampal Dysfunction: A Proof of Concept Study
Primary Purpose
Memory Loss Associated With Corticosteroid Use, Manic State Associated With Corticosteroid Use
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Levetiracetam, Keppra
Sponsored by
About this trial
This is an interventional prevention trial for Memory Loss Associated With Corticosteroid Use
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
Sites / Locations
- The University of Texas Southwestern Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00223223
First Posted
September 14, 2005
Last Updated
August 2, 2011
Sponsor
University of Texas Southwestern Medical Center
Collaborators
UCB Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00223223
Brief Title
Levetiracetam for Neuroprotection Against Corticosteroid-induced Hippocampal Dysfunction: A Proof of Concept Study
Official Title
Levetiracetam for Neuroprotection Against Corticosteroid-induced Hippocampal Dysfunction: A Proof of Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
UCB Pharma
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Loss Associated With Corticosteroid Use, Manic State Associated With Corticosteroid Use
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levetiracetam, Keppra
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Sherwood Brown, M.D., Ph.D.
Organizational Affiliation
UT Southwestern Medical Center at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Levetiracetam for Neuroprotection Against Corticosteroid-induced Hippocampal Dysfunction: A Proof of Concept Study
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