COMPARISON OF COGNITIVE, BEHAVIORAL EFFECTS OF LEVETIRACETAM, CARBAMAZEPINE

左乙拉西坦与卡马西平的认知、行为影响的比较

• 批准号: 7376137
• 负责人: KIMFORD J MEADOR
• 金额: $ 0.21万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376137
• 关键词: COMPARISON; COGNITIVE; BEHAVIORAL; EFFECTS; LEVETIRACETAM

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a double-blind, randomized, two period crossover study comparing the cognitive and behavioral effects of the commonly-prescribed antiepileptic drugs (AEDs) levetiracetam and carbamazepine in normal healthy volunteers. The study consists of 12 visits over a 25 week period. Forty five (45) normal healthy subjects will be treated with both levetiracetam (2000 mg/day) and carbamazepine [adjusted to a dose to obtain mid-range anticonvulsant blood level (ABL) with a target ABL = 8.5¿¿g/ml and a range = 6-12 ¿¿g/ml) for 8 weeks each. Each AED treatment period will be followed by a four day taper and washout period off AED for the remainder of the month. Cognitive and behavioral function testing along with safety testing will be conducted at pretreatment baseline, the end of each randomization AED maintenance period, and after the final washout period. SPECIFIC AIMS: The overall aim of the proposed study is to compare the effects of levetiracetam versus carbamazepine on neuropsychologic function after eight weeks treatment in healthy adults. We also plan to compare the safety and tolerability of levetiracetam versus carbamazepine in healthy adults. Hypothesis: Our hypothesis is that the cognitive effects of carbamazepine will be greater than those of levetiracetam.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项双盲、随机、两期交叉研究，比较常用抗癫痫药物（AEDs）左乙拉西坦和卡马西平对正常健康志愿者的认知和行为影响。这项研究包括在25周内进行12次访问。45例正常健康受试者分别应用左乙拉西坦（2000 mg/d）和卡马西平（调整剂量以达到抗惊厥血药水平（ABL）的中程水平，目标ABL = 8.5 g/ml，范围= 6-12 g/ml）治疗8周。每个AED治疗期之后是4天的逐渐减少和当月剩余时间的AED洗脱期。认知和行为功能测试以及安全性测试将在预处理基线、每个随机化AED维持期结束时以及最终洗脱期后进行。具体目的：拟议研究的总体目的是比较左乙拉西坦与卡马西平治疗8周后对健康成人神经心理功能的影响。我们还计划在健康成人中比较左乙拉西坦与卡马西平的安全性和耐受性。假设：我们的假设是卡马西平的认知作用将大于左乙拉西坦。