EUCTR2016-004954-13-Outside-EU/EEA进行中（未招募）1 期
A Multi-center, Randomized, Open-label, Parallel-group, Dose-titration, Add-on, Comparative Study in Evaluating the Efficacy and Safety of Zonisamide (Zonegran) and Lamotrigine (Lamictal) for Subjects with Refractory Simple Partial, Complex Partial or Partial with Secondary Generalized Seizures
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participants must sign and date the informed consent form
- •Clinical diagnosis as refractory epilepsy
- •Male or female participants =16 and =70 years old
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Progressive neurologic disease
- •Serious psychiatric disease
- •Hemolytic anemia
- •Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Acute intermittent porphyrias
- •Participants who have received study drugs (Zonisamide, Lamotrigine) in the past
- •Drug or alcohol addiction
- •Renal impairment (serum creatinine = 1.5 mg/dL), or hepatic abnormality (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x upper limit normal (ULN))
- •Stevens-Johnson syndrome
- •Progressive exfoliative dermatitis
- •Pregnant, lactating or of childbearing potential female
- •Regularly taking oral contraceptives
- •Hypersensitivity to study drugs
- •Severe cardiac disease (New York Heart Association Functional Class III and IV)
- •History of malignancy within 5 years
- •Participants who had received any investigational drugs (including any investigational
- •AEDs) within 1 month prior to screening
- •Participants with simple partial seizures without motor component
研究者
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