NCT00215592已完成4 期
An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 66
- 主要终点
- Seizure frequency, compared to baseline.
研究概览
简要总结
To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18-
- •Able and willing to give written informed consent in accordance with the ICH GCP Guidelines.
- •Female subjects of childbearing potential must not be pregnant (as confirmed by negative serum βHCG at screening and negative urine pregnancy test at baseline/during the study), must not be lactating and must use a medically acceptable form of contraception during the study and for at least 1 month after discontinuation of study drug. Medically acceptable contraception as defined here is the oral contraceptive pill, surgical sterilization or hormonal intrauterine device in place for at least 3 months. Women who are less than 2 years post-menopausal are considered to be of childbearing potential.
- •Focal epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the ILAE criteria.
- •Patients with a minimum of 4 partial seizures in the 8 weeks preceding the baseline visit as adequately recorded using a seizure diary card.
- •Patients should be receiving at least 1 but no more than 2 other AEDs as concomitant medication, and the dosage should be stable for at least 8 weeks before the baseline visit.
排除标准
- •History of status epilepticus within the last 5 years.
- •Patients with known significantly impaired renal function and/or severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed. Note Investigators should consult included SmPC as a guide.
- •Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation.
- •Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency.
- •Patient suffering from any CNS progressive disease that may confound study interpretation, any active CNS infection, demyelinating disease or degenerative neurological disease.
- •Patients with a significant drug sensitivity or significant allergic reaction to any drug including sulfonamides.
- •Subjects considered by the Investigator to be an unsuitable candidate for receiving Zonegran or considered unlikely to comply with the protocol.
- •Any patient contraindicated for Zonegran treatment as per attached SmPC.
- •Any patient who is pregnant and/or lactating.
结局指标
主要结局
Seizure frequency, compared to baseline.
次要结局
未报告次要终点
研究者
研究点 (66)
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