EUCTR2020-003141-11-ES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
eurocrine Biosciences, Inc.0 个研究点目标入组 24 人开始时间: 2021年6月9日最近更新:
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 described by the following criteria:
- •Male and female pediatric subjects aged between 4 and 12 years (inclusive) at screening
- •Genetic, structural, or unknown origin of EECSWS
- •SWI >50% during the first hour of overnight NREM sleep based on centralized reading
- •Focal, multifocal, or generalized spike-and-wave complexes with sleep activation based on investigator assessment and confirmed by central EEG reader
- •Cognitive stagnation or regression associated with continuous spike-and-wave during sleep (CSWS) as assessed by clinical evaluation
- •3. Have diagnosis of EECWS confirmed by the DCP
- •4. Subjects of childbearing potential must agree to use highly effective birth control methods consistently while participating in the study until 90 days after the last dose of the study treatment. A female subject of childbearing potential is defined as a subject who has had her first menstrual cycle (ie, menarche). A male subject of childbearing potential is defined as a subject who has reached spermarche. Acceptable methods of birth control are:
- •· Combined (estrogen and progestogen containing) hormonal contraception
- •· Progestogen-only hormonal contraception
- •· Intrauterine device (IUD)
- •· Intrauterine hormone-releasing system (IUS)
- •· Bilateral tubal occlusion
- •· Vasectomized partner
- •· Total abstinence from sexual intercourse (periodic abstinence is not acceptable)
- •Female subjects of childbearing potential must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test result at screening and a negative urine pregnancy test at Day 1.
- •5. Stable dosage and stable time of intake of at least 1 and up to 2 AEDs excluding systemic corticosteroids, from 4 weeks prior to screening and anticipated to be stable from screening until end of study (EOS). Vagal nerve stimulator (VNS) and ketogenic diet are not counted as AEDs.
- •6. Treatment other than AEDs (excluding systemic corticosteroids) must be at a stable dosage from 2 weeks prior to screening and anticipated to be stable from screening until EOS.
- •7. The subject, if using a VNS, must have had the VNS placed at least 3 months prior to screening with stable settings for =1 month; settings must remain stable throughout the duration of the study
- •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. Females who are pregnant or currently breastfeeding.
- •2. Lennox-Gastaut syndrome, Doose syndrome (epilepsy with myoclonic-atonic seizures), or Dravet syndrome.
- •3. Have a history of neurodegenerative disorders.
- •4. Have a history of autistic spectrum disorders.
- •5. Presence of a relevant psychiatric disease interfering with cognitive functioning (eg, depression, schizophrenia) as assessed by the investigator.
- •6. 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.
- •7. Life expectancy <12 months due to any concomitant disease.
- •8. Body weight <10 kg at randomization.
- •9. Had a medically significant illness within 30 days before Day 1.
- •10. Have a medically significant abnormality, physical or neurological examination finding, or any other measurements observed during screening or Day 1.
- •11. Clinically relevant findings in systolic blood pressure (SBP), diastolic blood pressure (DBP), or pulse rate at screening or Day 1.
- •12. Have an average triplicate ECG corrected QT interval using Fridericia’s formula (QTcF) >450 msec or presence of any significant cardiac abnormality at screening.
- •13. Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis) at screening.
- •14. Have aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) levels >2 × the upper limit of normal (ULN) at screening.
- •15. Have mild to severe renal impairment.
- •16. Have a history of tonic seizures during sleep.
- •17. Significant eye disease in the opinion of the ophthalmologist or findings that would preclude ophthalmic safety examinations.
- •18. Have received any prohibited medication within 30 days before screening (Section 9.7.1).
- •19. Have taken cannabinoids within 30 days of screening.
- •20. Systemic corticosteroids are prohibited for at least 8 weeks prior to screening.
- •21. Have ingested grapefruit or Seville orange (including grapefruit/Seville orange products or juice) from 7 days prior to screening.
- •22. Have a known or suspected diagnosis of Acquired Immune Deficiency Syndrome (AIDS), or have tested seropositive for human immunodeficiency virus antibody (HIV-Ab) or antigen at screening.
- •23. Tested positive at screening for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV-Ab) with confirmatory positive polymerase chain reaction (PCR) reflex test.
- •24. Planned surgical intervention related to structural abnormalities of the brain from screening through the duration of the study.
- •25. Have a significant risk of suicidal or violent behavior. Subjects will be excluded if they have:
- •Any lifetime history of suicidal behavior or
- •Any lifetime history of suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS), or based on clinical impression for younger subjects.
- •26. Known intolerance or hypersensitivity to NBI-827104, selective T-type calcium channel blockers, or to any of the excipients of the minitablet.
- •27. 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 tre
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