Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients With Epilepsy (Forest)
Epilepsy
About this trial
This is an interventional supportive care trial for Epilepsy focused on measuring epilepsy, memory, cognition, memantine
Eligibility Criteria
Inclusion Criteria:
- Adult patients with temporal lobe epilepsy, aged 18-65
- Seizure frequency of less than three per month
- Stabilized treatment for epilepsy, including AEDs and vagus nerve stimulation
- Intelligence Quotient of >70
- 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.)
- Able to count seizures accurately and maintain a seizure diary
- Recent AED levels performed within the last month within therapeutic range
Exclusion Criteria:
- Progressive neurologic disease
- Severe medical illness, including renal insufficiency
- Severe depression, bipolar disease or psychosis
- Pregnant or lactating women.
Sites / Locations
- University of California, Davis
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Memantine
Placebo
After a two-month prospective baseline during which seizure frequency and neurocognitive parameters are documented, patients will be randomized to either memantine or placebo and evaluated after twelve months on study drug. The treatment period will consist of a one month dose escalation phase, followed by an eleven month maintenance phase. The dose escalation is 5 mg in PM for days 1-7, 5 mg twice daily for days 8-14, 5 mg in AM and 10 mg in PM for days 15-21 and 10 mg twice daily from day 22 and continue.
After a two-month prospective baseline during which seizure frequency and neurocognitive parameters are documented, patients will be randomized to either memantine or placebo and evaluated after twelve months on study drug. The treatment period will consist of a one month dose escalation phase, followed by an eleven month maintenance phase. The dose escalation is 5 mg in PM for days 1-7, 5 mg twice daily for days 8-14, 5 mg in AM and 10 mg in PM for days 15-21 and 10 mg twice daily from day 22 and continue.