ISRCTN12811235进行中（未招募）1 期
ongwing: An open-label extension study for patients with Dravet syndrome who previously participated in studies of STK-001
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- 性别
- All
入选标准
- •1. Completed dosing with STK-001 and the End of Study Visit in Study STK 001-DS-102, with an acceptable safety profile per the Investigator's judgment
- •2. Satisfactory compliance with study visits and procedures in Study STK 001-DS-102 per Investigator and Sponsor judgment
- •3. Completed Study STK-001-DS-102 within 4 weeks of the start of their participation in Study STK-001-DS-502, unless approved by the Sponsor
排除标准
- •1. Met any withdrawal criteria from Study STK-001-DS-102
- •2. Current treatment as maintenance therapy with an antiepileptic drug acting primarily as a sodium channel blocker including phenytoin, carbamazepine, oxcarbazepine, lamotrigine, lacosamide, or rufinamide
- •3. Clinically significant unstable medical conditions other than epilepsy
- •4. Clinically relevant symptoms or a clinically significant illness (in the judgment of the Investigator) in the 4 weeks prior to Screening/Baseline of Study STK-001-DS-502, other than epilepsy
- •5. Spinal deformity or other condition that may alter the free flow of CSF or has an implanted CSF drainage shunt
- •6. Prior treatment (or is being treated) with an investigational product (other than STK-001) since participating in Study STK 001 DS-102
- •7. Participating in an observational study
研究者
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