Overview

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

Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborator:
UCB Pharma
Treatments:
Etiracetam
Levetiracetam
Piracetam
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