CLINICAL EXPERIENCE AND USE OF SABRIL IN PATIENTS WITH PARTIAL SEIZURES

SABRIL 在部分性癫痫发作患者中的临床经验和使用

• 批准号: 6115779
• 负责人: KATHERINE HENRY
• 金额: $ 2.1万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6115779
• 关键词: anticonvulsants; clinical research; clinical trials; drug adverse effect; human subject; human therapy evaluation; nervous system disorder chemotherapy; partial seizure

The goal of this multicenter, open-label, flexible-dose, long-term study is to further evaluate the safety and efficacy associated with the use of Sabril in epilepsy patients having partial seizures, and whose lifestyle has been adversely affected by poor seizure control and/or adverse events from currently marketed anti-epilepsy drugs (AEDs). Sabril (500 mg tablets) will be supplied in open-label bottles. The dosage will be titrated up to a maintenance dose of 2 to 3 g/day. The maximum allowable dose for the study is 6 g/day, as determined by the investigator dependent on patient response. Efficacy will be measured by the patient's response to Sabril with regard to seizure control, seizure frequency and seizure type. In addition, patient responses to selected quality-of-life questions will be measured with the QOLIE-10 (Quality of Life in Epilepsy) instrument, and patient and physician global assessment of drug therapy will be evaluated. Safety parameters will be assessed through collection of adverse events and monitoring laboratory values.

这项多中心、开放标签、剂量灵活的长期研究的目标是进一步评估使用Sabril治疗癫痫患者的安全性和有效性，这些患者有部分癫痫发作，他们的生活方式因癫痫发作控制不佳和/或目前销售的抗癫痫药物(AEDs)的不良事件而受到不利影响。Sabril(500毫克片剂)将以开放标签瓶装供应。该剂量将滴定至每天2至3克的维持量。这项研究的最大允许剂量为每天6g，由研究人员根据患者的反应确定。疗效将通过患者对Sabril在癫痫控制、癫痫发作频率和癫痫类型方面的反应来衡量。此外，患者对选定的生活质量问题的反应将使用QOLIE-10(癫痫生活质量)仪器进行测量，并将对患者和医生对药物治疗的全球评估进行评估。将通过收集不良事件和监测实验室数值来评估安全参数。