NCT00699972已完成3 期
A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 390
- 试验地点
- 94
- 主要终点
- Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study:
- •Participated in a study involving administration of an investigational compound or device within 1 month (or no less than 21 days) prior to Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer.
- •Pregnant and/or lactating.
- •Participated in previous perampanel studies.
- •Presence of nonmotor simple partial seizures only.
- •Presence of primary generalized epilepsies or seizures, such as absences and or myoclonic epilepsies.
- •Presence or previous history of Lennox-Gastaut syndrome.
- •A history of status epilepticus within approximately 12 months prior to Visit
- •Seizure clusters where individual seizures cannot be counted.
- •A history of psychogenic seizures.
- •Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject's safety or the study conduct.
- •Scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however those who have previously documented "failed" epilepsy surgery will be allowed.
- •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 less than 3 times the upper limit of normal (ULN).
- •Evidence of significant active hematological disease; white blood cell (WBC) count <= 2500/µL (2.50 1E+09/L) or an absolute neutrophil count <= 1000/µL (1.00 1E+09/L).
- •A clinically significant electrocardiogram (ECG) abnormality, including prolonged QTc defined as >450 msec.
- •Suffering from psychotic disorder(s) and/or unstable recurrent affective disorder(s) evident by use of antipsychotics or have had a suicide attempt(s) within approximately the last 2 years.
- •Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
- •History of drug or alcohol dependency or abuse within approximately the last 2 years.
- •Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
- •If felbamate is used as a concomitant AED, subjects must be on felbamate for at least 2 years, with a stable dose for 2 months (or no less than 49 days) prior to Visit
- •They must not have a history of white blood cell (WBC) count below 2500/µL (2.50 1E+09/L), platelets below 100,000, liver function tests (LFTs) above 3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If subjects received felbamate in the past, it must have been discontinued 2 months (or no less than 49 days) prior to Visit
- •Concomitant use of vigabatrin. Subjects who took vigabatrin in the past must be off vigabatrin for approximately 5 months prior to Visit 1 and must have documentation showing no evidence of a vigabatrin associated clinically significant abnormality in a visual perimetry test.
- •Concomitant use of barbiturates (except for seizure control indication) within 1 month (or no less than 21 days) prior to Visit
- •Use of intermittent rescue benzodiazepines (ie, 1-2 doses over a 24-hr period considered one-time rescue) 2 or more times in a 1-month period prior to Visit 1; or
- •Any condition(s) that will make the subject, in the opinion of the Investigator, unsuitable for the study.
研究组 & 干预措施
1
Experimental
干预措施: E2007 (perampanel) (Drug)
2
Experimental
干预措施: E2007 (perampanel) (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)
时间窗: Baseline (Pre-randomization) through Week 19
Seizure frequency per 28 days was derived from the information recorded in the subject diaries.
次要结局
- Percentage of Participants Who Were Responders(Baseline (Pre-randomization) through Week 19)
- Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)(Baseline (Pre-randomization) through Week 19)
研究者
研究点 (94)
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