Phase 3 Study of Progesterone vs Placebo Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 294
- 试验地点
- 15
- 主要终点
- Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency
研究概览
简要总结
The purpose of this investigation was to determine if cyclic adjunctive progesterone supplement is superior to placebo in the treatment of intractable seizures in women with and without catamenial epilepsy.
详细描述
This is a 6-month study. The first 3 months will gather baseline information on seizures, antiepileptic drug levels , menstrual cycles, hormone levels, emotional function, and quality of life. The second 3 months will assess the effects of treatment on these parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject must be between the ages of 13 and
- •Subject must have a history of seizures (documented by EEG).
- •Subject must have had at least 2 seizures or auras per month during the past 3 months.
- •Subject must be on stable antiepileptic drug therapy for at least 2 months.
- •Subject must have cycle intervals between 21 and 35 days during 6 months prior to entry.
排除标准
- •Subject that is pregnant or lactating.
- •Subject that is on major tranquilizers, antidepressant medications, or reproductive hormones.
- •Subject that is unable to document seizures.
- •Subject that has progressive neurological or systemic disorder or > 2-fold elevation in liver enzyme levels
研究组 & 干预措施
Catamenial Epilepsy: Progesterone Lozenges
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
干预措施: Progesterone Lozenges (Biological)
Catamenial Epilepsy: Placebo Lozenges
Subjects with catamenial epilepsy received matched placebo lozenges
干预措施: Matched Placebo Lozenges (Other)
Noncatamenial Epilespy:Progesterone Lozenges
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
干预措施: Progesterone Lozenges (Biological)
Noncatamenial Epilespy: Placebo Lozenges
Subjects without catamenial epilepsy received matched placebo lozenges
干预措施: Matched Placebo Lozenges (Other)
结局指标
主要结局
Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency
时间窗: 9 years
Percent of women who show a greater than 50% decline in average daily seizure frequency
次要结局
- Percentage of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency for Secondary Generalized, Complex Partial and Simple Partial Seizures Considered Separately(9 years)
- Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type.(9 years)
- Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment.(9 years)
- Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.(9 years)
研究者
Andrew Herzog
Professor of Neurology
Beth Israel Deaconess Medical Center