NCT00223223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

August 3, 2011

Status Verified

September 1, 2005

Enrollment Period

9 months

First QC Date

September 14, 2005

Last Update Submit

August 2, 2011

Conditions

Memory Loss Associated With Corticosteroid UseManic State Associated With Corticosteroid Use

Interventions

Levetiracetam, KeppraDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Interventions

Levetiracetam

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • E. Sherwood Brown, M.D., Ph.D.

    UT Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

February 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

August 3, 2011

Record last verified: 2005-09

Locations

US(1)