PROGESTERONE THERAPY FOR WOMEN WITH EPILEPSY

描述(申请人摘要)：这是一种随机、安慰剂对照、 双盲多中心临床试验将评估辅助剂的疗效 环孕酮治疗在减少难治性癫痫发作中的作用 在患有局部性癫痫的女性中。有相当大的科学依据 有证据表明，雌激素通常会增加，而黄体酮 减少神经元兴奋性和癫痫发作。初步公开试验表明 周期服用辅助性天然孕酮补充剂 可将大多数女性的癫痫发作频率降低50%以上 使难治性癫痫发作加剧。口服合成孕激素 对比而言，均未显示出明显疗效。黄体酮没有被广泛使用 作为扣押管理的一个辅助工具，因为它的好处还没有 确凿地证明了。拟议的临床试验将需要640人 研究对象。在基线阶段，癫痫发作/月经表将记录 基线癫痫发作频率，并确定癫痫发作是否表现为 加剧的月经型。科目将被分成 月经组和非月经组。每组将以2：1的比例随机分配 分为黄体酮治疗组和安慰剂治疗组。癫痫发作频率在 3个月的治疗将与基线进行比较，同时进行监测 抗癫痫药物和激素水平。 拟议的临床试验对女性具有相当大的潜在意义 患有癫痫。约30%的女性癫痫患者患有顽固性癫痫 癫痫，这是持续的癫痫发作，尽管有抗癫痫药物的试验， 使用。据估计，这些妇女中有35%患有月经性癫痫。 病情恶化。如果，根据初步观察，该小组的答复是 对荷尔蒙疗法有利的是，人们预计黄体酮可能会受益 大约(1,000,000 x.30 x.35)100,000名患有月经性癫痫的妇女 也许更多没有先天经验的女性表现出对荷尔蒙的敏感。 导致癫痫发作。

DESCRIPTION (Applicant's Abstract): This randomized, placebo-controlled, double-blind, multicenter clinical trial will assess the efficacy of adjunctive cyclic progesterone therapy in lessening the frequency of intractable seizures in women with localization related epilepsy. There is considerable scientific evidence to suggest that estrogen generally increases while progesterone decreases neuronal excitability and seizures. Preliminary open trials suggest that the cyclic administration of adjunctive natural progesterone supplement may lessen seizure frequency by over 50% in the majority of women with catamenially exacerbated intractable seizures. Oral synthetic progestins, in contrast, have not shown significant efficacy. Progesterone is not widely used as an adjunct to seizure management because its benefits have yet to be definitively demonstrated. The proposed clinical trial will require 640 subjects. During the baseline phase, seizure/menstrual charts will document baseline seizure frequency and determine if seizure occurrence shows a catamenial pattern of exacerbation. The subjects will be divided into catamenial and non-catamenial groups. Each group will be randomized in a 2:1 ratio into progesterone and placebo treatment groups. Seizure frequency during 3 months of treatment will be compared to baseline, while monitoring antiepileptic drug and hormone levels. The proposed clinical trial has considerable potential significance for women with epilepsy. Approximately 30% of women with epilepsy have refractory seizures, that is persistent seizures despite trials of antiepileptic drug, use. It is estimated that 35% of these women have catamenial seizure exacerbation. If, on the basis of preliminary observations, this group responds favorably to hormonal therapy, one would expect that progesterone may benefit approximately (1,000,000 x .30 x .35) 100,000 women with catamenial epilepsy and perhaps many more women with no a priori demonstrated hormonal sensitivity to seizure occurrence.