EUCTR2006-000956-42-DE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
相关药物
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
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 seizures
- •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 form.
- •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-RET-E22-302 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
研究者
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