NCT03340064已完成3 期
An Open-Label, Single-Arm, Multicenter Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 21
- 主要终点
- Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 6
研究概览
简要总结
This is a study to confirm the efficacy of levetiracetam as adjunctive treatment or as monotherapy in pediatric epilepsy subjects aged 1 month to less than 4 years of age with partial seizures.
详细描述
The study will consist of 2 periods. The First Period (6 weeks drug treatment) is designed to confirm efficacy of levetiracetam (LEV), and the Second Period is designed to evaluate the long-term efficacy and safety of LEV.
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 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have a diagnosis of epilepsy with partial onset seizures whether or not secondarily generalized
- •Male or female from 1 month to <4 years of age. Pre-term infants aged <1 year are to be stratified into an appropriate age category using the best estimate of their corrected gestational age
- •For subjects on adjunctive therapy, subject must be on a stable antiepileptic drug (AED) regimen for the Selection and Evaluation Periods of the study. Minor adjustments to the dose of current AEDs are allowed only prior to Visit
- •Monotherapy subjects must not receive AED treatment, receive temporary AED treatment, or switch an AED prior to Visit 1
- •Subject weighs >=3.0 kg
- •Subject may have Vagal Nerve Stimulation (VNS) which has been implanted for at least 6 months prior to Visit 1; the settings must be stable for at least 2 months prior to Visit
- •Activated VNS must be counted as 1 of the 2 AEDs
- •Subject must have experienced at least 2 observable partial seizures, with or without secondary generalization during each 7-day period during the 2 weeks prior to Visit
- •This time period (the 2 weeks prior to Visit 1) will be referred to as the Retrospective Baseline Period. This seizure information (including type, frequency, and date) must have been recorded on a daily record card (DRC) in order to be acceptable
- •If epilepsy surgery has been performed prior to study entry, subjects must have a documented failed epilepsy surgery outcome at least 4 weeks prior to Visit 1
- •The use of intermittent benzodiazepines, phenobarbitals, and phenytoins is allowed as long as the frequency is not greater than 1 single administration per week for at least 2 weeks prior to Visit 1 and throughout study participation. If benzodiazepines are used more than once a week, they must be considered as 1 of the AEDs
排除标准
- •Subject has been taking any medication (other than their concomitant AEDs) that influences the central nervous system (CNS) for which they had not been on a stable regimen for at least 1 month prior to Visit 1
- •Subject is taking any medication that may interfere with the absorption, distribution, metabolism, or excretion of the concomitant AEDs or levetiracetam (LEV) during the course of the study
- •Subject has received any investigational medication or device within 30 days prior to Visit 1
- •Subject has taken LEV prior to the study
- •Subjects using felbamate who have presented with clinically significant abnormalities and/or hepatic function during felbamate treatment, and subjects who are taking felbamate <1year from the date of Visit 1
- •History of status epilepticus requiring hospitalization during the 30 days prior to Visit 1, except for status epilepticus occurring during the first 10 days of life
- •Subject has a treatable seizure etiology
- •Subject is on a ketogenic diet (concomitantly or within 30 days prior to Visit 1)
- •Subject has epilepsy secondary to progressing cerebral diseases
- •Subject has a current diagnosis of Rasmussen's syndrome, Landau-Kleffner disease or Lennox-Gastaut syndrome
- •Clinically significant deviations from reference range values for renal function or any of the other laboratory parameters required for this study, as determined by the Investigator
- •Clinically significant acute or chronic illness (as determined during the physical examination or from other information available to the Investigator)
- •Allergy to pyrrolidine derivatives or a history of multiple drug allergies
- •Subject is known to have a terminal illness
- •Subject has a disorder or condition that may interfere with the absorption, distribution, metabolism, or excretion of medications
- •Subject has a history of or presence of pseudoseizures
- •Subject has any medical condition that might interfere with the subject's study participation
- •Subject has ≥3x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%)
研究组 & 干预措施
Levetiracetam
Experimental
Subjects aged 1 month to <6 months will be started on levetiracetam (LEV) 14 mg/kg/day at Visit 3. The dose may be increased by LEV 14 mg/kg/day for subjects aged 1 month to <6 months at 2-week intervals to a maximum dose of 42 mg/kg/day. Subjects aged 6 months to <4 years will be started on LEV 20 mg/kg/day at Visit 3. The dose may be increased by LEV 20 mg/kg/day at 2-week intervals to a maximum dose of 60 mg/kg/day.
At Visit 6, subjects may enter the Second Period or enter the Down-Titration Period followed by a Safety Follow-Up Period. Subjects who do not enter the Second Period will be down-titrated. The dose will be decreased by LEV 14 mg/kg/day for subjects aged 1 month to <6 months or by LEV 20 mg/kg/day for subjects aged 6 months to <4 years at 2-week intervals to 0 mg/kg/day.
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 6
时间窗: From Baseline (Week 0) to Visit 6 (up to Week 6)
The percent difference in partial seizure frequency per week at Baseline and Study Visit 6 (Week 6) was computed as: {\[(Number of partial seizures per week at Baseline) minus (Number of partial seizures per week at Study Visit 6)\] divided by (Number of partial seizures per week at Baseline)} multiplied by 100. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on adjunctive therapy.
次要结局
- Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy(From Baseline (Week 0), Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, and Safety follow-up (up to Week 295))
- Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy(From Baseline (Week 0), Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, EOS/EDV Week 2, EOS/EDV Week 4, and Safety follow-up (up to Week 295))
- Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 4(From Baseline (Week 0) to Visit 4 (up to Week 2))
- Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 5(From Baseline (Week 0) to Visit 5 (up to Week 4))
- Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy(From Baseline (Week 0), Week 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, EOS/EDV (up to Week 295), and Safety follow-up (up to Week 295))
- Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy(From Baseline (Week 0), Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, and Safety follow-up (up to Week 295))
- Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the Combined First and Second Period(From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295))
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the First Period(From Baseline (Week 0) to Visit 6 (up to Week 6))
- Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the First Period(From Baseline (Week 0) to Visit 6 (up to Week 6))
- Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the First Period(From Baseline (Week 0) to Visit 6 (up to Week 6))
- Percentage of Participants With TEAEs During the Combined First and Second Period(From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295))
- Percentage of Participants With Treatment-emergent SAEs During the Combined First and Second Period(From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295))
研究者
研究点 (21)
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