EUCTR2011-000265-12-GR进行中（未招募）不适用
A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel-group Study with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Adjunctive Perampanel in Primary Generalized Tonic-Clonic Seizures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 164
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
- •Ages 12 years and older
- •Clinical diagnosis of PGTC seizures (with or without other subtypes of primary generalized seizures) and experiencing = 2 PGTC seizures during the 8-week period prior to randomization
- •Have had a routine electroencephalogram (EEG) prior to or during the Baseline Period with electroencephalographic features consistent with primary generalized epilepsy; other concomitant anomaly should be explained by adequate past medical history
- •On a fixed dose of one to two concomitant AEDs for a minimum of 30 days prior to Baseline; only one inducer AED (i.e., carbamazepine, oxcarbazepine, or phenytoin) out of the maximum of two AEDs will be allowed
- •A vagal nerve stimulator (VNS) will be allowed, but it must have been implanted = 5 months prior to Baseline (stimulator parameters can not be changed for 30 days prior to Baseline and for the duration of the study)
- •Have had a computed tomography (CT) or magnetic resonance imaging (MRI) within the last 10 years (for adults) and 5 years (for adolescents) that ruled out a progressive cause of epilepsy
- •A ketogenic diet will be allowed as long as the subject has been on this diet for 5 weeks prior to randomization
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 66
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 82
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •Participated in a study involving administration of an investigational compound or device within the 30 days prior to Baseline, or within approximately 5 half-lives of the previous investigational compound, whichever is longer
- •Pregnant and/or nursing
- •Participated in previous perampanel studies
- •A history of status epilepticus that required hospitalization within 12 months prior to Baseline
- •Seizure clusters where individual seizures cannot be counted
- •A history of psychogenic seizures
- •Any suicidal ideation with intent with or without a plan at or within 6 months prior to Visit 2 (i.e., answering Yes” to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS)
- •Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the subject’s safety or study conduct
- •Concomitant diagnosis of Partial Onset Seizures (POS)
- •Progressive neurological disease
- •Clinical diagnosis of Lennox-Gastaut syndrome
- •History of drug or alcohol dependency or abuse within 2 years prior to Screening
- •Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (e.g., 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 60 days prior to Baseline. They must not have a history of white blood cell (WBC) count below = 2500/µL (2.50 1E+09/L), platelets < 100,000/µL, liver function tests (LFTs) > 3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow dysfunction while receiving felbamate.
- •Concomitant use of vigabatrin: Subjects who took vigabatrin in the past must be discontinued for approximately 5 months prior to Baseline, and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test
- •Concomitant use of barbiturates (except for seizure control indication) within 30 days prior to Baseline
- •Use of intermittent rescue benzodiazepines (i.e., one to two doses over a 24-hour period considered one-time rescue) two or more times within the 30 days prior to Baseline
- •Subjects who are known to be HIV positive
- •Subjects with active viral hepatitis (A, B, or C) as demonstrated by positive serology
研究者
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