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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00223223
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 3, 2011
Sponsor:
Collaborator:
UCB Pharma
Information provided by:
University of Texas Southwestern Medical Center

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.


Condition or disease Intervention/treatment Phase
Memory Loss Associated With Corticosteroid Use Manic State Associated With Corticosteroid Use Drug: Levetiracetam, Keppra Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Levetiracetam for Neuroprotection Against Corticosteroid-induced Hippocampal Dysfunction: A Proof of Concept Study
Study Start Date : February 2005
Actual Primary Completion Date : November 2005
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Steroids





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223223


Locations
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United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
UCB Pharma
Investigators
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Principal Investigator: E. Sherwood Brown, M.D., Ph.D. UT Southwestern Medical Center at Dallas
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Responsible Party: E. Sherwood Brown PI, UT Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00223223    
Other Study ID Numbers: 112004-003
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: September 2005
Additional relevant MeSH terms:
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Memory Disorders
Bipolar Disorder
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Mental Disorders
Bipolar and Related Disorders
Levetiracetam
Anticonvulsants
Nootropic Agents