Double-Blind, Randomized, Two Period Crossover Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs.
研究概览
简要总结
Double-blind, randomized, two period crossover comparison of the cognitive and behavioral effects of Eslicarbazepine acetate and Carbamazepine in healthy volunteers.
详细描述
This study is a double-blind, randomized, two period crossover design. The study consists of 6 visits over a 21 week period. Forty six (46) normal healthy subjects will be treated with both Eslicarbazepine acetate (ESL, 800 mg/day) and Carbamazepine (CBZ, 800mg/day) for 6 weeks and 3 days each (maintenance 4 weeks and taper 3 days). Each antiepileptic drug (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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults between the ages of 18 and 55 years old.
- •Male or female
排除标准
- •Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease or pregnancy.
- •Presence or history of drug or alcohol abuse.
- •The use of concomitant medications, which are known to affect ESL or Carbamazepine or the use of any concomitant medications that may alter cognitive function (see Section VII.E for a partial list).
- •Use of oral contraceptive hormones or other medications that could be affected by ESL or Carbamazepine.
- •Prior adverse reaction to or prior hypersensitivity to either study medication or to related compounds.
- •Prior participation in studies involving anticonvulsant medications.
- •Subjects who have received any investigational drug within the previous thirty days.
- •Subjects with IQ < 70 as determined by the Peabody Picture Vocabulary Test.
- •Presence of HLA B*1502 in subjects of Asian descent; this will be obtained at screening in subjects of Asian descent.
研究组 & 干预措施
Eslicarbazepine
Randomized to eslicarbazepine 800mg po bid in crossover design.
干预措施: Eslicarbazepine (Drug)
Carbamazepine
Randomized to carbamazepine 400mg po bid in crossover design.
干预措施: Carbamazepine (Drug)
结局指标
主要结局
Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs.
时间窗: At the end of each 6-week drug treatment period.
Z score of cognitive tests at end of each 6-week drug treatment period for each intervention (i.e., Eslicarbazepine and Carbamazepine). The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poor cognitive performance compared to the mean and positive numbers represent higher cognitive performance compared to the mean.
次要结局
- Dual Task Percent of Time in Box.(Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.)
- Overall Z-score for Executive Function.(At the end of each 6-week drug treatment period.)
- MCG Paragraph Recall Scores.(Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.)
- Profile of Mood States (POMS) Score.(Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.)
研究者
Kimford Jay Meador
Professor
Stanford University