A Multicenter, Uncontrolled, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Perampanel as Substitute for Oral Tablet in Subjects With Partial Onset Seizures (Including Secondarily Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 13
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of perampanel administered as a 30-minute intravenous infusion after switching from oral tablets (8 to 12 milligrams per day [mg/day]) as an adjunctive therapy in participants with epilepsy with partial onset seizures (POS) (including secondarily generalized seizures) or primary generalized tonic-clonic (PGTC) seizures.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of epilepsy with POS (including secondarily generalized seizures) or PGTC seizures according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (1981).
- •Receiving a stable dose regimen of oral perampanel.
- •Receiving a concomitant stable dose regimen of marketed AEDs. No change of dosing regimen for concomitant AEDs is planned during the intravenous Treatment and Follow-up Phases.
- •Considered reliable and willing to be available for the study period by the investigator, and are able to record seizures and report AEs by themselves or have a caregiver who can record seizures and report AEs for them.
排除标准
- •A history of drug or alcohol dependency or abuse.
- •A history of status epilepticus.
- •Unsuitable for venipuncture and intravenous administration.
- •Requires medical intervention due to safety issues related to concomitant administration of AEDs.
- •A history of suicidal ideation/attempt.
- •Clinical symptoms or imaging suggest progressive central nervous system (CNS) abnormality, disorder, or brain tumor.
- •Current evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigators could affect the participant's safety, interfere with the study assessments or need prohibited medications as specified in the study protocol.
- •Clinically significant abnormal laboratory values.
- •Females of childbearing potential who:
- •In the Pretreatment Phase, are breastfeeding or pregnant (as documented by a positive beta-human chorionic gonadotropin [β-hCG] test).
- •Within 28 days before Visit 1, did not use a highly effective method of contraception, which includes any of the following:
- •total abstinence (if it is their preferred and usual lifestyle).
- •an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).
- •a contraceptive implant.
- •an oral contraceptive (with additional barrier method). (Participant must be on a stable dose of the same oral contraceptive product for at least 28 days before Day 1 of the Treatment Phase and throughout the entire study period, and for 28 days after the last dose of study drug).
- •have a vasectomized partner with confirmed azoospermia.
- •Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after the last dose of study drug.
- •Participation in a study involving administration of an investigational drug or device within 28 days before Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer.
- •A prolonged QT interval corrected using Fridericia's formula (QTcF) interval (greater than [>] 450 millisecond [ms]) as demonstrated by a repeated ECG.
- •A vagus nerve stimulation (VNS) implanted.
研究组 & 干预措施
Perampanel
Participants with POS with or without secondarily generalized seizures or PGTC seizures will receive perampanel 8 to 12 milligram (mg), tablets, orally, once daily for 28 days (Day -28 to Day -1) in Pretreatment Phase and followed by 8 to 12 mg dose of perampanel as intravenous infusion for 30 minutes, once daily from Day 1 to Day 4 in Treatment Phase, and then again 8 to 12 mg, tablets, orally, once daily from Day 5 to Day 11 in Follow-up Phase as an adjunctive therapy, along with 1 to a maximum of 3 marketed concomitant antiepileptic drugs (AEDs).
干预措施: Perampanel (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product, any new disease or exacerbation of an existing disease, any deterioration in nonprotocol-required measurements of a laboratory value or other clinical test that resulted in symptoms, a change in treatment, or discontinuation of study drug, recurrence of an intermittent medical condition not present pretreatment, an abnormal laboratory test result was considered an AE if the identified laboratory abnormality led to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not.
Number of Participants With Markedly Abnormal Clinical Laboratory Parameter Values During Treatment and Follow-up Phase
时间窗: Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after last dose)
Number of Participants With Abnormal Vital Sign Values During Treatment and Follow-up Phase
时间窗: Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)
Number of Participants With Serious Adverse Events (SAEs)
时间窗: Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)
A SAE was defined as any untoward medical occurrence that at any dose: Resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect.
Number of Participants With Abnormal Body Weight During Treatment and Follow-up Phase
时间窗: Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)
Number of Participants With Clinically Significant Markedly Abnormal Electrocardiogram (ECG) Value During Treatment and Follow-up Phase
时间窗: Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after the last dose)
次要结局
- Mean Seizure Frequency Per Day in Pretreatment Phase, Treatment Phase and Follow-up Phase(Up to 39 days (Pretreatment Phase: up to 28 days; Treatment Phase: up to 4 days; Follow-up Phase: up to 7 days after the last dose))
- Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel(Pretreatment Phase-Day -1: Pre-dose, 0.5 hours, 1 hours and 1.5 hours post-dose; Treatment Phase-Day 1, Day 2, Day 3 and Day 4: Pre-dose and 0.5 hours after start of intravenous infusions)