Overview

Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients With Epilepsy

Status:
Withdrawn
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
All
Summary
People with epilepsy often experience problems with their memories and other thinking skills that get worse over time. The investigators hope to learn more about whether a drug called memantine can help improve or stabilize (keep the same) memory and other thought processes in people with epilepsy by blocking a chemical that is released in the brain during seizures. The investigators also want to see if memantine changes the frequency (how often) people with epilepsy have seizures. Memantine is currently approved by the United States Food and Drug Administration (FDA) for treatment of patients with Alzheimer's disease.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Michael A. Rogawski, MD, PhD
University of California, Davis
Collaborator:
Forest Laboratories
Treatments:
Memantine
Criteria
Inclusion Criteria:

1. Adult patients with temporal lobe epilepsy, aged 18-65

2. Seizure frequency of less than three per month

3. Stabilized treatment for epilepsy, including AEDs and vagus nerve stimulation

4. Intelligence Quotient of >70

5. Native English speaker (most of the neuropsychological/cognitive tests have yet to be
translated and/or validated in non-English speaking populations. Thus, at this point
we are limited to testing English speakers, only.)

6. Able to count seizures accurately and maintain a seizure diary

7. Recent AED levels performed within the last month within therapeutic range

Exclusion Criteria:

1. Progressive neurologic disease

2. Severe medical illness, including renal insufficiency

3. Severe depression, bipolar disease or psychosis

4. Pregnant or lactating women.