JPRN-jRCT1080220031未知4 期
Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval)
适应症
试验速览
- 阶段
- 4 期
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- ot applicable 至 ot applicable(—)
- 性别
- All
入选标准
- •Patient meeting the criteria for inclusion, who intend to continue the treatment with intrathecal baclofen using the implanted pump system after approval of NDA. The written informed consent by the patients or the legal representative is a must.
- •[Criteria for inclusion]
- •1) Patient effective to the intrathecal baclofen therapy at the long term safety clinical trial(phase 3), and is judged as no safety issue by the doctor.
- •2) Patient who can be regularly followed during clinical trial.
排除标准
- 未提供
研究者
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