PROGESTERONE THERAPY FOR WOMEN WITH EPILEPSY

描述（申请人摘要）：这是一个随机的，安慰剂对照的， 双盲、多中心临床试验将评估 环孕酮治疗顽固性癫痫发作的疗效观察 局部相关性癫痫的女性。有相当多的科学 有证据表明，雌激素通常会增加，而孕激素则会增加， 降低神经元兴奋性和癫痫发作。初步公开试验表明 周期性服用天然黄体酮补充剂 可能会减少癫痫发作频率超过50%，在大多数妇女与 会加剧顽固性癫痫发作口服合成孕激素， 相反，没有显示出显著的功效。Progesterone没有广泛使用 作为缉获管理的辅助手段，因为它的好处尚未得到 明确证明。临床试验需要640 科目在基线阶段，将记录癫痫发作/月经图表 基线癫痫发作频率，并确定癫痫发作是否显示 加重的月经模式。受试者将分为 月经和非月经群体。每组将以2：1的比例随机分配 孕酮和安慰剂治疗组的比例。癫痫发作频率 3个月的治疗将与基线进行比较，同时监测 抗癫痫药物和激素水平。 拟议的临床试验对妇女具有相当大的潜在意义 患有癫痫大约30%的女性癫痫患者有难治性 癫痫发作，即持续性癫痫发作，尽管抗癫痫药物试验， 使用.据估计，这些妇女中有35%有月经发作 加重如果根据初步观察， 有利于激素治疗，人们会期望孕酮可能受益 大约（1，000，000 x .30 x .35）100，000名患有月经性癫痫的妇女 也许还有更多没有先验表现出荷尔蒙敏感性的女性 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.