An Open, Multicentric, Non-Interventional Observational Study Investigating Retention, Seizure Control and Tolerability in Epilepsy Patients With Partial Onset Seizures Receiving Eslicarbazepine Acetate (ESL) in Different Therapy Situations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eisai GmbH
- 入组人数
- 246
- 主要终点
- Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL)
研究概览
简要总结
This is a non interventional prospective study. Centers will enroll adult participants with partial onset seizures with or without secondary generalisation for whom the clinician has decided to initiate eslicarbazepine acetate (ESL) as an adjunctive therapy or monotherapy prior to the decision to take part in this study. Participants to be enrolled into the study will receive ESL either as an adjunctive therapy to one baseline antiepileptic drug (AED) or to at least two baseline AEDs or as monotherapy. Participants will be seen at baseline and at a follow-up visit after approximately 6 months to assess retention, efficacy, tolerability, quality of life (optional), and cognitive performances (optional).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Partial onset seizures with or without secondary generalisation in conjunction with a diagnosed epilepsy of symptomatic or unknown course.
- •The decision to prescribe Eslicarbazepine acetate (ESL) was taken independent of and prior to enrollment into this study.
- •Treatment with ESL is in agreement with the valid summary of product characteristics (SmPC) version, particularly with the licensed indication.
- •Age 18 years and older.
- •Participant's written consent.
排除标准
- •Known psychogenic non-epileptic attacks.
- •Participation in an interventional study.
- •Previous enrollment in the current study.
结局指标
主要结局
Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL)
时间窗: At follow-up visit (occurring after approximately 6 months of treatment)
次要结局
- Responder Rate(Baseline (the 3 months period prior to initiation of treatment with ESL) and 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment))
- Change from baseline in total seizure frequency(Baseline (the 3 months period prior to initiation of treatment with ESL) and 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment))
- Change from baseline in seizure frequency by seizure type(Baseline (the 3 months period prior to initiation of treatment with ESL) and 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment))
- Percentage of participants achieving seizure free state(3 months period prior to follow-up visit (occurring after approximately 6 months of treatment))
- Change from baseline in Quality of Life in Epilepsy Inventory-10 (QOLIE-10)(Baseline (the 3 months period prior to initiation of treatment with ESL) and 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment))
- Change from baseline in NeuroCog FX subset scores(Baseline (the 3 months period prior to initiation of treatment with ESL) and at follow-up visit (occurring after approximately 6 months of treatment))
- Percentage of participants with Adverse Events (AEs)(From signing of informed consent up to the follow-up visit (occurring after approximately 6 months of treatment))