EUCTR2020-003141-11-DE进行中（未招募）1 期
Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep - Study to evaluate NBI-827104 versus placebo in pediatric subjects with EECSWS
eurocrine Biosciences, Inc.0 个研究点目标入组 24 人开始时间: 2021年10月1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
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent by the parent(s) or legal representative(s) and, if applicable, assent from developmentally capable pediatric subjects.
- •2. Diagnosis of EECSWS
- •3. Have diagnosis of EECWS confirmed by the Diagnosis Confirmation Panel (DCP).
- •4. Stable dosage and stable time of intake of at least 1 and up to 3 ASMs, excluding pulse therapies such as systemic corticosteroids and intravenous immunoglobulin (IVIG), from 4 weeks prior to screening and anticipated to be stable from screening until end of study (EOS). Vagal nerve stimulator or (VNS) and ketogenic diet are not counted as ASMs
- •5. Treatment other than ASMs (excluding pulse therapies such as systemic corticosteroids and IVG) must be at a stable dosage from 2 weeks prior to screening and anticipated to be stable from screening until EOS.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Lennox-Gastaut syndrome, Doose syndrome (epilepsy with myoclonicatonic seizures), or Dravet syndrome.
- •2.Presence of a relevant psychiatric disease interfering with cognitive or behavioral functioning (eg, depression, schizophrenia, autism spectrum disorders) unless associated with the EECSWS diagnosis as assessed by the investigator.
- •3. Presence of relevant neurological disorders other than EECSWS and its underlying conditions as judged by the investigator. Symptomatic conditions underlying EECSWS (eg, neonatal strokes) have to be stable for at least 1 year prior to screening.
- •4. Body weight <10 kg at randomization.
- •5. Clinically relevant findings in systolic blood pressure (SBP), diastolic blood pressure (DBP), or pulse rate at screening or Day 1 as determined by the investigator.
- •6. Have an average triplicate ECG corrected QT interval using Fridericia's formula (QTcF) >450 msec or presence of any significant cardiac abnormality at screening.
- •7. Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry including thyroid function parameters, and urinalysis) at screening as determined by the investigator.
- •8. Have aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) levels >2 × the upper limit of normal (ULN) at screening.
- •9. Have mild to severe renal impairment as determined by the investigator.
- •10. Have taken cannabinoids, excluding Epidiolex®/Epidyolex®, within 30 days of screening.
- •11. Pulse therapy such as systemic corticosteroids and IVIG are prohibited for at least 8 weeks prior to screening.
- •12.Planned surgical intervention related to structural abnormalities of the brain from screening through the duration of the study.
- •13. Have received any other investigational drug within 30 days or 5 half-lives (if known), whichever is longer, of Day 1 or plan to use an investigational drug (other than the study treatment) during the study.
- •14. Any circumstances or conditions, which, in the opinion of the investigator, may affect participation in the study or compliance with the protocol.
研究者
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