An Open-label, Multi-centre, Multi-national Post-marketing Non-interventional Observational Study of the Use of Zonisamide (ZNS) in the Adjunctive Treatment of Adult Patients With Partial Onset Seizures Treated With One Antiepileptic Drug (AED) as Baseline Medication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 104
- 主要终点
- Retention Rate of Zonisamide (ZNS) after 6 months from Baseline
研究概览
简要总结
This is a Non-interventional Prospective Study. Centres will enroll adult patients with partial onset seizures for whom the clinician has decided to initiate ZNS as an adjunctive therapy prior to the decision to take part in this study. Patients to be enrolled into the study are not sufficiently controlled with one dug licensed for the use of monotherapy in partial onset seizures. Patients will be seen at baseline and then during normal clinical visits at intervals which are appropriate to the typical practice of the treating clinician. Patients will be assessed at baseline and then at least 3 and 6 months after the baseline.
详细描述
Open-label, Multi-centre, Multi-national Post-marketing, Non-interventional Observational Study
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •The decision to prescribe ZNS 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 the use as monotherapy in partial onset seizures
- •Based on the physician's clinical judgment, the patient seizure activity is not controlled sufficiently with the current monotherapy and it is in the patient's best interest to be prescribed adjunctive ZNS
- •Patient was prescribed ZNS no longer than 2 weeks before baseline
- •Treatment with ZNS has to be commenced in line with the drug's license and ZNS SmPC (Summary of Product Characteristics)
- •Aged 18 years or older
- •Capable of understanding the purpose of the study, fully informed and having given written informed consent.
排除标准
- •Patients that have started ZNS outside the approved SmPC at enrolment
- •Simultaneous participation in an interventional clinical trial and/or taking an investigational drug
- •Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the patient.
研究组 & 干预措施
Zonisamide tablets
干预措施: Zonisamide tablets (Drug)
结局指标
主要结局
Retention Rate of Zonisamide (ZNS) after 6 months from Baseline
时间窗: Up to 6 months
The retention rate or the proportion of patients still receiving ZNS after 6 months will be assessed. At each of the two visits after 3 months and 6 months (final assessment or early discontinuation), the clinician will record whether the patient is still on ZNS treatment, or whether treatment has been discontinued.
次要结局
- Change in Seizure Frequency after 3 and 6 months from Baseline(Baseline, 3 months and 6 months)