NCT00448916已完成3 期
A 12-month Open-label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Pregabalin In Pediatric Patients With Partial Onset Seizures
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.18 个研究点 分布在 3 个国家目标入组 54 人开始时间: 2007年5月最近更新:
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
- 入组人数
- 54
- 试验地点
- 18
- 主要终点
- Number of Participants With Adverse Events (AE).
研究概览
简要总结
The study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 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
- •Completion of study A0081074
排除标准
- •Primary generalized seizures
- •Progressive CNS pathology
- •Failure to tolerate pregabalin in study A0081074
研究组 & 干预措施
Pregabalin
Experimental
Orally-administered pregabalin
干预措施: Pregabalin (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AE).
时间窗: 12 Months
An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect.
次要结局
- Derived Body Mass Index Data (BMI) at Month 12/Early Termination.(Month 12/Early Termination)
- Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.(Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up)
- Height at Month 12/Early Termination.(Month 12/Early Termination)
- Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).(Week 1 to 12 Months)
- Number of Participants With Hematotolgical Abnormalities.(12 Months)
- Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.(Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.)
- Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).(Visit 1 to 12 Months)
- Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.(Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up)
- Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).(Visit 1 to 12 Months)
- Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months).(Visit 1 to 12 Months)
- Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy).(12 Months)
- Number of Participants With Abnormalities in Endocrine Panel (Hormones).(12 Months)
- Number of Participants With Abnormalities in Creatine Kinase.(12 Months)
- Seizure Frequency.(28 Days)
- Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).(12 Months)
研究者
研究点 (18)
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