Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Difference in neuropsychological test scores over time between memantine and placebo treated groups of temporal lobe epilepsy patients.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Progressive neurologic disease
- •Severe medical illness, including renal insufficiency
- •Severe depression, bipolar disease or psychosis
- •Pregnant or lactating women.
研究组 & 干预措施
Memantine
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.
干预措施: Memantine (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in neuropsychological test scores over time between memantine and placebo treated groups of temporal lobe epilepsy patients.
时间窗: 5 years
次要结局
未报告次要终点