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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam, Keppra

Drug

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

UCB Pharma

Registry information

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Sep 22, 2005
Registry last updated: Aug 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.