EUCTR2006-000956-42-HU进行中（未招募）1 期
A multicenter, open-label, long-term, safety, tolerability and efficacy study of retigabine in adult epilepsy patients with partial-onset seizures (Extension of Study VRX-RET-E22-302)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 376
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient has successfully completed the Maintenance and Transition
- •phases of Study VRX-RET-E22-302 for the treatment of partial-onset
- •2. Patient is expected to benefit from participation in the study in the
- •opinion of the Investigator.
- •3. Women of childbearing potential and fertile males have to agree to
- •use a medically acceptable method of birth control and females shall
- •have a negative urine pregnancy test at visit 0, which will be confirmed
- •by the serum ß-HCG pregnancy test at the last visit (Visit 11) of the
- •Transition phase of Study VRX-RET-E22-302. A woman of childbearing
- •potential is defined as a female who is biologically capable of becoming
- •pregnant. A medically acceptable method of birth control includes an
- •intrauterine device in place for at least 3 months, surgical sterilization
- •(e.g. tubal ligation), or adequate barrier methods (e.g., diaphragm and
- •foam). An oral contraceptive alone is not considered adequate for the
- •purpose of this study.
- •4. In the opinion of the Investigator, patient is able to understand
- •verbal and written instructions and will adhere to all study schedules
- •and requirements.
- •5. Patient or legal guardian (if applicable) is informed, given ample time
- •and opportunity to read and/or understand about his/her participation
- •in the study, and has signed and dated the written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 361
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Patient meets any of the withdrawal criteria in the previous VRX-RETE22-
- •302 study or is experiencing an ongoing serious adverse event.
- •2. Patient is receiving any investigational drug or using any
- •experimental device in addition to Retigabine for treatment of epilepsy
- •or any other medical condition.
- •3. Patient has any other condition that would prevent compliance with
- •the study procedures or proper reporting of AEs.
- •4. Female patient who has a positive pregnancy test at any time during
研究者
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