Observational Sentinel Sites Study in Infants Younger Than 12 Months Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution in Usual Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 101
- 试验地点
- 27
- 主要终点
- Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit
研究概览
简要总结
The purpose of this observational study is to broaden the knowledge of the known safety and efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than 12 months when treated according to routine clinical practice. Their data will be collected until they reach the age of 13 months.
详细描述
This non-interventional sentinel sites post-authorization safety study (PASS) aims to collect additional data on use of Keppra® (Levetiracetam) oral solution in clinical practice, and on efficacy and safety of Keppra® (Levetiracetam) in infants younger than12 months. Epileptic patients between the age of 1 month and 11 months inclusive can be invited for participation to the non-interventional sentinel sites PASS, after the physician has decided to initiate therapy with Keppra® (Levetiracetam) oral solution (100 mg/ml bottle) and patient has so far been treated with Keppra® (Levetiracetam) for no longer than 10 days. The patients will be followed and their data will be collected until they reach the age of 13 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of epilepsy
- •being treated with Keppra® Oral Solution
- •aged between 1 month and 11 months inclusive at study baseline
排除标准
- 未提供
结局指标
主要结局
Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit
时间窗: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
Number of patients with any Treatment-Emergent Adverse Events (TEAEs) as reported by the patient's parent and/or caregiver or observed by the treating physician during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).
次要结局
- Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit(From Baseline to the last Treatment Visit (maximum 12 months))
- Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up(From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up))
- Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period(From Baseline through the last Treatment Visit (maximum 12 months))
- Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit(From Baseline through the last Treatment Visit (maximum 12 months))
- Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit(From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up))
- Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit(From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up))
- Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit(From Baseline to the last Treatment Visit (maximum 12 months))
- Global Evaluation Scale of Epilepsy Severity (GES)(From Baseline to the last Treatment Visit (maximum time frame is 12 months))
- Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit(From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up))
- Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit(From Baseline to the last Treatment Visit (maximum 12 months))
- Global Evaluation Scale of the Psychomotor Development (GES)(From Baseline to the last Treatment Visit (maximum 12 months))