EUCTR2015-002500-91-ES进行中（未招募）1 期
A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,350
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
- •To be eligible to participate in this trial, patients must meet all of the following criteria:
- •1. Completed one of the parent trials: RPC01-201 or RPC01-301
- •2. Does not have a condition that would require withdrawal from one of the parent trials (RPC01-201 or RPC01-301)
- •3. Has no conditions requiring treatment with a prohibited concomitant medication
- •4. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
- •5. Patients of reproduction potential (males and females) must practice an acceptable method of birth control (acceptable methods of birth control in this trial include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long acting injectable contraceptive, vasectomy or double-barrier method [condom or diaphragm with spermicide OR condom and diaphragm]) during trial participation and for 30 days after their last dose of treatment of investigational drug or true sexual abstinence (periodic abstinence [calendar, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). Patients must follow the strictest applicable local requirement as specified by the Regulatory Agency or Ethics Committee approving the trial.
- •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 2350
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients that have a condition that would require withdrawal from one of the parent trials (RPC01-201 or RPC01-301)
研究者
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