EUCTR2022-001256-42-GR进行中（未招募）1 期
A Randomized, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Carisbamate (YKP509) as Adjunctive Treatment for Seizures Associated with Lennox-Gastaut Syndrome in Children and Adults, with Optional Open- Label Extension
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 252
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. Subject must have a documented history of Lennox-Gastaut syndrome by:
- •a. Evidence of more than one type of seizure, of which at least one should be an atonic or tonic seizure
- •b. History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern <3.0 Hz)
- •c. History of developmental delay
- •2. Male or female subjects
- •3. Subjects must be age 4-55 years at the time of consent/assent
- •4. Must have been <11 years old at the onset of LGS
- •5. Subjects must have experienced at least 8 drop seizures with
- •potential to fall (tonic, atonic, tonic-clonic) during the 4-week Baseline period preceding randomization (minumim of 4 drop seizures in the first two weeks and 4 in the last two weeks). Drop seizures are defined as a countable seizure involving the entire body, trunk, or head that led or could have led to a fall, injury, slumping in a chair, or hitting the subject's head on a surface. All drop seizure types must be countable (either as isolated seizures or as countable isolated seizures in a cluster).
- •6. Subjects must have been receiving 1 to 4 concomitant anti-seizure medications (ASMs) at a stable dose for at least 4 weeks before Visit 1
- •7. If not taking Epidiolex, subjects may take other approved cannabidiol or over the counter cannabidiol products. If taking cannabidiol other than Epidiolex, consult Medical Monitor to determine if it counts as a concomitant ASM.
- •8. Dietary therapy and any CNS stimulator settings must be stable for 4 weeks prior to baseline and maintain stable regimen throughout the study. The dietary therapy and CNS stimulators are not counted as an ASM.
- •9. Parents or caregivers must be able to keep accurate seizure diaries
- •10. Subject is either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to study entry and for 2 weeks after dose of study drug.
- •11. Subject and/or caregiver/legal representative must be willing and able to give informed assent/consent for participation in the study
- •12. Subject and their caregiver must be willing and able (in the investigator’s opinion) to comply with all study requirements
- •13. History of COVID-19 vaccination is permitted.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 168
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 84
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation, unless there is a progressive brain tumor
- •2. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject's safety or study conduct
- •3. Subjects who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline
- •4. Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling
- •5. Current use of felbamate with less than 12 months of continuous exposure
- •6. Subjects who took vigabatrin in the past must have discontinued it at least 5 months before Visit 1. Subjects taking vigabatrin should have documentation showing no evidence of a vigabatrin-associated visual field abnormality.
- •7. Subject who had a history of hypoxia which needed emergency resuscitation within 12 months prior to baseline
- •8. Status epilepticus within 12 weeks prior to Visit 1
- •9. Any clinically significant illness (including COVID-19) in the 4 weeks prior to Visit 1, as evaluated by the Investigator
- •10. Subject has clinically significant abnormal laboratory values, in the investigator’s opinion, at Visit 1 or time of randomization (Visit 2)
- •11. Subject has a history of any serious drug-induced hypersensitivity, e.g., toxic epidermal necrolysis, or Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]) or any drug-related rash requiring hospitalization
- •12. Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS) or other neurostimulation for epilepsy device implanted or activated <5 months prior to enrollment. Stimulation parameters that have been stable for <4 weeks, or Battery life of unit not anticipated to extend for duration of trial.
- •13. Subject is pregnant, may be pregnant, lactating or planning to be pregnant
- •14. Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2 (i.e., answering Yes to questions 4 or 5 in the Suicidal Ideation section of the agespecific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 years and above who are able to be evaluated
- •15. Any suicidal behavior within 2 years before Visit 2 (i.e., answering YES to any question in the Suicidal behavior section of the age-specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated.
- •16. Evidence of significant active hepatic disease. Stable elevations of liver enzymes (alanine aminotransferase (ALT), and aspartate aminotransferase (AST)) due to concomitant medication(s) will be allowed if they are <3 x ULN
- •17. Subject with total bilirubin [TBL] >2 x ULN (except for Gilbert’s syndrome).
- •18. Active viral hepatitis (B or C) as demonstrated by positive serology at the Screening visit (Visit 1)
- •19. History of positive antibody/antigen test for human immunodeficiency virus (HIV)
- •20. If taking Epidiolex, subject may not use other approved cannabidiol or over the counter cannabidiol products
- •21. Scheduled for epilepsy-related surgery, VNS insertion, or any other stimulators/surgery during the projected course of the study
- •22. Subject who has participated in any clinical study of an investigational product or device in the 30 days prior to the screening visit (Visit 1)
- •23. Concomitant use of medications
研究者
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