NL-OMON53987招募中3 期
A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies to Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2) - TAK-935-3003 (ENDYMION 2)
Takeda0 个研究点目标入组 21 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
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
- 2 至 64（—）
入选标准
- •- Pediatric and adult subjects with DS or LGS from antecedent soticlestat phase
- •3 clinical studies;
- •- received at least 12 weeks of treatment (combined titration and Maintenance
- •Period) with soticlestat or placebo in the antecedent study;
- •- did not have a serious or severe adverse event (AE) that, in the
- •investigator*s or sponsor*s opinion, was related to the study drug and would
- •make it unsafe for the subject to continue receiving the study drug; and
- •- in the opinion of the investigator, have the potential to benefit from the
- •administration of soticlestat.
排除标准
- •- Unstable, clinically significant neurologic (other than DS or LGS), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. - Abnormal and clinically significant electrocardiogram (ECG) abnormality at Visit 1, including QT interval with Fridericia correction method (QTcF) >450 ms. - Currently pregnant or breastfeeding or is planning to become pregnant within 30 days of the last dose of study drug. - Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or has positive answers on item numbers 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1.
研究者
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