A Placebo-Controlled, Escalating Dose, Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pregabalin In Pediatric Patients With Partial Onset Seizures
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Partial onset seizures, incompletely controlled on 1-3 medications
- •At least 1 seizure per 28 days, on average
排除标准
- •Primary generalized seizures
- •Progressive CNS pathology
研究组 & 干预措施
Pregabalin
干预措施: Pregabalin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment
时间窗: Day 8 up to 28 days after open-label dose of study medication
Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for open-label treatment included events between Day 8 and 28 days after the open-label dose that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.
Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment
时间窗: Baseline to Day 7
Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for double-blind treatment included events between baseline and Day 7 that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.
次要结局
- Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis(Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8)
- Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis(Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8)
- Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis(Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8)
- Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis(Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8)
- Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis(Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8)
- Plasma Decay Half-Life (t1/2): Single-Dose Analysis(Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8)
- Apparent Oral Clearance (CL/F): Multiple-Dose Analysis(Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8)
- Apparent Oral Clearance (CL/F): Single-Dose Analysis(Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8)
- Renal Clearance (CLr): Multiple-Dose Analysis(0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8)
- Renal Clearance (CLr): Single-Dose Analysis(0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8)
- Number of Participants With Clinically Significant Change in Physical and Neurological Findings(Baseline up to 7 days post-last dose of study medication)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis(Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8)
- 28-Day Seizure Frequency Rate(Baseline up to 7 days post-last dose of study medication)
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis(Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8)