EUCTR2015-002379-81-FR进行中（未招募）1 期
International, multi-center, double blind 9-month FOLLOW-UP extension study assessing the long term safety and tolerability of PXT3003 in patients with Charcot-Marie-Tooth Disease type 1A.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pharnext
- 入组人数
- 300
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
- •Male or female patients with all of the following inclusion criteria will be considered for randomization:
- •1.Patient previously randomized to the initial PLEO-CMT study (protocol CLN-PXT3003-02) and having completed 15 months of double-blind treatment in that study, including all procedures required at the Study Termination visit (V6)
- •2. Patient providing a signed written informed consent to participate in the extension study and willing and able to comply with all study procedures and scheduled visits.
- •3. Female patients must agree to continue using an approved method of birth control throughout the extension study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 270
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients with any of the following criteria will be excluded from entry:
- •1.Presenting any 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 unauthorized concomitant treatments, as study CLN-PXT3003-02.
研究者
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