NCT01002820已完成2 期
A Treatment Protocol for Ganaxolone as add-on Therapy in Adult Patients With Uncontrolled Partial-onset Seizures Deriving Benefit From Protocol 1042-0601
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 7
- 主要终点
- Investigators Global Assessment
研究概览
简要总结
This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects who have completed all study visits from previous protocol 1042-0601 and have been deemed eligible by the Investigator as:
- •having had no major adverse events thought to be drug related
- •deriving benefit from ganaxolone treatment
- •be properly informed of the nature and risks of the study and give written informed consent prior to study entry
- •must be willing to use a medically acceptable method of birth control and if female of child-bearing potential, have a negative qualitative serum pregnancy test
排除标准
- •significant medical or surgical condition at screening or that develops during protocol participation that might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems, or other conditions that would place the subject under increased risk
- •unwilling to use a double-barrier method of birth control or submit to a serum pregnancy test
- •history of chronic non-compliance with drug regimens
- •females currently breastfeeding
- •AST or ALT levels greater than 3 times the upper limit of normal at screen
- •Inability to withhold grapefruit or grapefruit products during the study
研究组 & 干预措施
participants
Experimental
all subjects participating in 0602 are receiving ganaxolone for seizure control
干预措施: ganaxolone (Drug)
结局指标
主要结局
Investigators Global Assessment
时间窗: Screening through 52 weeks
Investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. The investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. Responses categories were Improved Markedly, Improved Moderately, Improved Slightly and No change from baseline.
次要结局
未报告次要终点
研究者
研究点 (7)
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