JPRN-jRCT2080224757已完成3 期
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's Disease
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 791
研究概览
简要总结
The study treatment was terminated early at the discretion of the sponsor based on an independent review committee (iDMC) recommendation, and the primary efficacy endpoint of the study was not met. The results of secondary efficacy endpoints were in general consistent with the primary analysis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 25age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •Manifest HD diagnosis, defined as a DCL score of 4
- •- Independence Scale (IS) score >= 70
- •- Genetically confirmed disease by direct DNA testing with a CAP score >400
- •- Clinical assessment to ensure individual has intact functional independence at baseline to maintain self-care and core activities of daily living (ADLs).
排除标准
- •- Any serious medical condition or clinically significant laboratory, or vital sign abnormality at screening that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
- •- Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug
研究者
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