DRKS00025524尚未招募不适用
A 12-month, non-interventional, observational multinational study to evaluate effectiveness, tolerability, and quality of life of brivaracetam adjunctive therapy in earlier treatment lines in adult patients with history of partial-onset seizures in daily clinical practice. - BRITOBA/EP0103
Parexel International (IRL) Limited (Clinical Research Organisation)0 个研究点目标入组 600 人开始时间: 2021年10月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 99 Years（—）
- 性别
- All
入选标准
- •1. The decision by the treating physician to prescribe BRV must be made independently from participation in the non-interventional study, and is in line with the drug’s license and the (local) Summary of Product Characteristics (SmPC).
- •2. A Patient Data Consent Form must be signed and dated by the patient.
- •3. The patient must be considered by the treating physician to be reliable and capable of adhering to the protocol.
- •4. The patient must not have been previously treated with BRV.
- •5. The patient must have a history of epilepsy for at least 6 months.
- •6. The patient must have a history of partial-onset (focal) seizures. The patient must have had at least 1 POS (focal aware [simple partial], focal with impaired awareness [complex partial], or focal to bilateral tonic clonic seizure [secondarily generalized tonic clonic]) within 3 months prior to Baseline (Visit 1).
- •7. The patient must be receiving =1 AED at the start of BRV treatment. The patient must have failed no more than 3 lifetime AEDs used for the treatment of seizures, including all prior and concomitant AEDs at Baseline (Visit 1) before BRV initiation (excluding benzodiazepines used short term as rescue medications).
排除标准
- •Patients who have not initiated BRV within 90 days of initial data consent
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