CTIS2024-511852-42-00进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Ambulatory and Non-Ambulatory Participants with Spinal Muscular Atrophy with Open-Label Extension (RESILIENT) - BHV2000-301
Biohaven Pharmaceuticals Inc.0 个研究点目标入组 169 人开始时间: 2024年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 169
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 64（—）
- 性别
- All
入选标准
- •Spinal Muscular Atrophy confirmed by genetic diagnosis of 5q-autosomal recessive SMA as well as SMN2 copy number, Ambulant or Non-ambulant, Treated with an SMA disease-modifying therapy and anticipated to remain on that same treatment regimen dose throughout the trial including nusinersen, risdiplam and/or history of onasemnogene abeparvovec
排除标准
- •Cannot have previously taken anti-myostatin therapies, Must weigh at least 15 kg, Respiratory insufficiency, defined by the medical necessity for invasive or non-invasive ventilation for daytime treatment while awake (use overnight or during daytime naps is acceptable)., History of Spinal Fusion within 6 months of Screening. MAGEC rod non-surgical adjustments are allowed during the study, Presence of an implanted shunt for the drainage of CSF or an implanted central nervous system (CNS) catheter
研究者
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