EUCTR2008-003334-19-BG进行中（未招募）不适用
Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR) as Adjunctive Therapy in Subjects with Refractory Partial Epilepsy on up to Three Concomitant Antiepileptic Medications
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
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. Able to provide written informed consent and agree to comply with study procedures.
- •2. Male or female aged 18 to 66 years, inclusive.
- •3. Successful completion of the 804P301 study.
- •4. Sexually active women, unless surgically sterile (at least 6 months prior to Study Medication [SM] administration) or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to SM administration] sexual
- •partner) for at least four weeks prior to SM administration, and must agree to continue using such precautions through the End of Study visit. Cessation of birth control after this point should be discussed with a responsible physician.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Clinically significant change in health status that, in the opinion of the Investigator, would
- •prevent the subject from participating in this study or successfully completing this study.
- •2. Any reason which, in the opinion of the Investigator, would prevent the subject from
- •participating in the study.
研究者
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