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临床试验/NCT01830400
NCT01830400已完成不适用

An Open-label, Multi-centre, Multi-national Post-marketing Non-interventional Prospective Study Evaluating Retention Rate, Seizure Control and Tolerability of Eslicarbazepine Acetate (ESL) as Adjunctive Treatment to One Baseline Antiepileptic Drug in Adult Patients With Partial-Onset Seizures With or Without Secondary Generalisation

Eisai Inc.0 个研究点目标入组 254 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Eisai Inc.
入组人数
254
主要终点
Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline

研究概览

简要总结

This was a Non-interventional Prospective Study. Centres enrolled adult patients with partial-onset seizures with or without secondary generalisation for whom the clinician had decided to initiate Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the decision to take part in this study. Patients enrolled into the study were not sufficiently controlled with one drug licensed for the use as monotherapy in partial-onset seizures. Patients were seen at baseline and then during normal clinical visits at intervals. Patients in this study were assessed for efficacy and tolerability at baseline and then at least 3 and 6 months after the baseline.

研究设计

研究类型
Observational
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

入选标准

  • The decision to prescribe ESL was made by the physician before and independently of his/her decision to include the patient in the study
  • Patients treated with one drug licensed for monotherapy in partial onset seizures
  • Based on the physician's clinical judgment, the patient seizure activity was not controlled sufficiently with a current monotherapy and it was in the patient's best interest to be prescribed adjunctive ESL
  • Patient was prescribed ESL no longer than 2 weeks before the baseline
  • Treatment with ESL was to be commenced in line with the drug's license and Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC)
  • Aged 18 years or older
  • Signed written informed consent

排除标准

  • Patients that had started ESL outside the approved SPC at enrolment
  • Simultaneous participation in an interventional clinical trial

研究组 & 干预措施

Eslicarbazepine Acetate tablets

干预措施: Eslicarbazepine Acetate tablets (Drug)

结局指标

主要结局

Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline

时间窗: 6 months

次要结局

  • Change in Overall Seizure Frequency after 3 and 6 months from Baseline(Baseline, 3 months and 6 months)

研究者

发起方
Eisai Inc.
申办方类型
Industry
责任方
Sponsor

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