Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients With Epilepsy
Information source: University of California, Davis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: Memantine (Drug); Placebo (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: Michael A. Rogawski, MD, PhD Official(s) and/or principal investigator(s):
Michael Rogawski, MD, PhD, Principal Investigator, Affiliation: University of California, Davis Health System
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.
Clinical Details
Official title: Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients With Epilepsy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Difference in neuropsychological test scores over time between memantine and placebo treated groups of temporal lobe epilepsy patients.
Detailed description:
This is a double-blind, placebo-controlled trial of the effects of memantine in adult
epilepsy patients. Patients will be assessed for neurocognitive outcomes, seizure frequency
and side effects. 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. The
neuropsychological battery performed during baseline will be repeated at the end of the
twelve month treatment period. No special procedures are required for this study, except
the neuropsychological testing, which is not a routinely performed evaluation for adult
epilepsy outpatients.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
University of California, Davis, Sacramento, California 95817, United States
Additional Information
Starting date: July 2010
Last updated: October 17, 2012
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