NCT04015141进行中（未招募）2 期
An Open-Label Study With Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Eisai Inc.
- 入组人数
- 100
- 试验地点
- 84
- 主要终点
- Proportion of 50% Responders For All Seizures During the Maintenance Period of Core Study
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2).
详细描述
This study will consist of a Core Study, Extension Phase A and Extension Phase B.
- Core Study will consist of the following 2 phases: Pretreatment (4 weeks screening or baseline period) and Treatment Period. The Treatment Period (23 weeks) of Core study include Titration period (10 weeks) and Maintenance period (13 weeks).
- Extension Phase A will consist of a Treatment Period (33 weeks) and a Follow-up Period (4 weeks). All participants who will complete the Core Study will be eligible to participate in Extension Phase A of the study.
- Extension Phase B will only be for participants who reside in countries where perampanel (oral tablets or oral suspension) is not commercially available or an extended access program (EAP) is not yet implemented, participants have completed Extension Phase A, and who, in the opinion of the investigator, will continue to benefit from treatment with perampanel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants. Cohort 1: age 1 month to less than 18 years; Cohort 2: age 1 month to less than 2 years at the time of informed consent/assent. Participants below the age of 1 year must have been at least 36 weeks of gestational age at birth.
- •Have a diagnosis of epilepsy with a pediatric epileptic syndrome (Cohort 1) or epilepsy with POS with or without secondary generalization (Cohort 2).
- •Have had equal or greater than 4 seizures over the 4-week interval prior to enrollment visit.
- •Absence of any progressive cause of epilepsy that has been confirmed clinically or based on brain imaging (example, magnetic resonance imaging [MRI] scan or computed tomography [CT] or ultrasound [for less than 1 year old]).
- •Currently maintained on stable doses of 1 to a maximum of 4 approved antiepileptic drugs (AEDs). A prescription medical marijuana (including products containing cannabidiol) is counted as 1 of the maximum of 4 allowed AEDs; however, it cannot be the only concomitant AED if this product is not an approved AED in the country where the study site is located. Doses must be stable for at least 4 weeks (at least 2 weeks for participant less than [<] 6 months old) before Visit 1/Baseline or screening; only 1 enzyme-inducing antiepileptic drug (EIAED) (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 4 AEDs is allowed.
排除标准
- •Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before screening visit.
- •Have a history of status epilepticus that required hospitalization within 6 months before screening visit.
- •Have an unstable psychiatric diagnosis that may confound participant's ability to participate in the study or that may prevent completion of the protocol specified tests (example, significant suicide risk, including suicidal behavior and ideation within 6 months before screening visit 1, current psychotic disorder, acute mania).
- •Any suicidal ideation with intent with or without a plan within 6 months before enrollment visit (answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS) in participants aged 6 and above or based on the opinion of the Investigator for participants less than 6 years.
- •Are scheduled or confirmed or both to have epilepsy surgery within 6 months after screening visit; however, those who have previously documented "failed" epilepsy surgery will be allowed.
- •Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
- •Benzodiazepines for any indications other than epilepsy (example, anxiety/sleep disorders) prohibited from 1 month before Visit 1/Baseline or screening and during the study. Benzodiazepines for seizure control and as rescue medication are allowed.
- •A vagal nerve stimulator (VNS), responsive neurostimulator (RNS), or deep brain stimulator (DBS) implanted less than 5 months before screening visit or changes in parameter less than 4 weeks before screening visit (or thereafter during the study).
- •Use of perampanel within 30 days before screening visit, or perampanel was discontinued due to adverse reactions (perampanel-related) or lack of efficacy in case of previous exposure.
- •Weight less than 4.0 kilogram (kg) at Visit 1 (Baseline or screening).
研究组 & 干预措施
Perampanel
Experimental
Participants aged 1 month to less than 18 years with pediatric epileptic syndrome (Cohort 1) or aged 1 month to less than 2 years with POS (Cohort 2) will receive perampanel oral suspension or perampanel tablets, once daily up to 56 weeks.
干预措施: Perampanel Oral Suspension (Drug)
Perampanel
Experimental
Participants aged 1 month to less than 18 years with pediatric epileptic syndrome (Cohort 1) or aged 1 month to less than 2 years with POS (Cohort 2) will receive perampanel oral suspension or perampanel tablets, once daily up to 56 weeks.
干预措施: Perampanel Tablet (Drug)
结局指标
主要结局
Proportion of 50% Responders For All Seizures During the Maintenance Period of Core Study
时间窗: Week 10 to Week 23
A response of 50% will be defined as a decrease in 28-day seizure frequency of equal or greater than 50% compared to baseline seizure frequency.
次要结局
- Proportion of Participants Who Are Seizure-Free During the Maintenance Period of Core Study and During the Treatment Period of Core Study and Extension Phase A(Maintenance Period of Core study: Week 10 to Week 23; Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56)
- Change From Baseline in Seizure Frequency For All Seizures During the Treatment Period of Core Study and During the Treatment Period of Core Study and Extension Phase A(Baseline, Treatment Period of Core study: Week 23, Treatment Period of Core Study and Extension Phase A: Week 56)
- Percent Change From Baseline in Seizure Frequency For All Seizures During the Treatment Period of Core Study and During the Treatment Period of Core Study and Extension Phase A(Baseline, Treatment Period of Core study: Week 23, Treatment Period of Core Study and Extension Phase A: Week 56)
- Clinical Global Impression of Change (CGIC) at the End of the Treatment Period of Core Study and at the End of Extension Phase A(Treatment Period of Core Study: Week 23, Extension Phase A: Week 56)
- Subject Global Impression of Change (SGIC) at the End of the Treatment Period of Core Study and at the End of Extension Phase A(Treatment Period of Core Study: Week 23, Extension Phase A: Week 56)
- Change from Baseline in Lafayette Grooved Pegboard Test (LGPT) Parameters at the End of the Treatment Period of Core Study and at the End of Extension Phase A(Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56)
- Change from Baseline in Growth and Development Parameter - Weight(Baseline, Treatment Period of Core Study: Weeks 2, 5, 8, 10, 14, 18 and 23; Extension Phase A: Weeks 28, 40, 56, and 60)
- Proportion of 50% Responders During Treatment Period of Core Study and Extension Phase A(Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56)
- Proportion of 25% and 75% Responders for all Seizures, During Maintenance Period of Core Study and During Treatment Period of Core Study and Extension Phase A(Maintenance Period of Core study: Week 10 to Week 23; Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56)
- Change From Baseline in the Cognitive Drug Research (CDR) Parameter at the End of the Treatment Period of Core Study and at the End of Extension Phase A(Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56)
- Change from Baseline in CBCL Parameters at the End of the Treatment Period of Core Study and at the End of Extension Phase A(Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56)
- Change from Baseline in Growth and Development Parameter - Height(Baseline, Treatment Period of Core Study: Week 23; Extension Phase A: Weeks 28, 40, and 56)
- Change from Baseline in Growth and Development Parameter - Thyroid-Stimulating Hormone (TSH) Levels in Blood(Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56)
- Change from Baseline in Growth and Development Parameter - Free Triiodothyronine (fT3) and Free Thyroxine (fT4) Levels in Blood(Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56)
- Change from Baseline in Growth and Development Parameter - Insulin Like Growth Factors (IGF)-1(Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56)
- Change from Baseline in Growth and Development Parameter- Sexual Maturation Assessed by Tanner Staging(Baseline, Treatment Period of Core Study: Week 23, Extension Phase A: Week 56)
- Proportion of Participants with any Treatment-Emergent Reports of Suicidal Ideation and Behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) and Intensity of These Behaviors Assessed using C-SSRS Scores(Treatment period of Core Study: Weeks 0, 2, 5, 8, 10, 14, 18, and 23; Extension Phase A: Weeks 28, 46, 56 and 60)
- Change from Baseline in Number of Seizures Recorded on Electroencephalogram (EEG) at the End of the Treatment Period of Core Study and at the End of Extension Phase A(Baseline, End of the Treatment Period of Core Study: Week 23, End of Extension Phase A: Week 56)
- Number of Participants with at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)(From date of first dose of perampanel up to 28 days after the last dose of perampanel (Week 60))
- Number of Participants with Clinically Significant Abnormal Electrocardiograms(From date of first dose of perampanel up to Week 60)
- Number of Participants with Treatment Emergent Markedly Abnormal Laboratory Values(From date of first dose of perampanel up to Week 60)
- Number of Participants with Clinically Notable Vital Sign Results(From date of first dose of perampanel up to 28 days after the last dose of perampanel (Week 60))
研究者
研究点 (84)
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