A 30-month Safety and Efficacy Follow-up Study With Levetiracetam at Individualized Optimal Dose in Children (4-17 Years Old at Inclusion) Suffering From Typical Absences in Childhood Absence Epilepsy (CAE) or Juvenile Absence Epilepsy (JAE)

UCB Pharma0 个研究点目标入组 4 人开始时间: 2000年5月最近更新: 2013年9月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: UCB Pharma
入组人数: 4
主要终点: Continue levetiracetam treatment after participation in the pilot-study N162 or in study N163; Assess long-term safety profile and efficacy of levetiracetam

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This long-term open label follow-up trial gave pediatric subjects suffering from typical absences in CAE or JAE the opportunity to continue levetiracetam treatment after participation in the pilot study (study N162) or the double-blind study (study N163). Safety and efficacy data were obtained.

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: 4 Years 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Male/female 4-17 years old having participated in study N162 or in study N163
•suffering from typical absences with 3 Hz spike-wave discharges, with or without tonic-clonic seizures, in CAE or JAE
•expected reasonable benefit (efficacy and tolerability) of levetiracetam long term administration

排除标准

•allergy/intolerance to pyrrolidine derivatives and/or excipients
•use of > 2 concomitant antiepileptic treatment or valproate, ethosuximide or lamotrigine

结局指标

主要结局

Continue levetiracetam treatment after participation in the pilot-study N162 or in study N163; Assess long-term safety profile and efficacy of levetiracetam

次要结局

未报告次要终点

研究者

发起方

UCB Pharma

申办方类型

Industry

相似试验

已完成

2 期

Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset SeizuresPartial Onset Seizures

NCT01051193Nobelpharma88

已完成

4 期

Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid DependenceOpioid Dependence, on Agonist Therapy

NCT01903005Orexo AB668

已完成

2 期

Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)Retinopathy of Prematurity (ROP)

NCT02386839Shire76

进行中（未招募）

不适用

A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel DiseaseIndeterminate ColitisInflammatory Bowel DiseasesCrohn's DiseaseUlcerative Colitis

NCT00606346Janssen Biotech, Inc.4,970

已完成

3 期

Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset SeizuresEpilepsy, Partial

NCT00152516UCB Pharma255