EUCTR2004-002260-25-AT进行中（未招募）不适用
A randomized, phase III, double blind, active-controlled, two-armed, multi-center study on efficacy and safety of once-daily oxcarbazepine (-modified release formulation) versus twice-daily oxcarbazepine (Timox®) in 300 patients with partial onset epilepsy - OXC retard
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •Patients with partial onset epilepsy with or without secondar generalization with either monotherapy with carbamazepine or oxcarbazepine or therapy with carbamazepine or oxcarbazepine and one additional antiepileptic drug
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. epilepsy secondary to progressive methabolic disease, malignant neoplasm, substance abuse, or active infection; epilepsy due to an intracranial process without any progression may be tolerated.
- •2. primary generalized epilepsy
- •3. severe cardiac, pulmonary, hematological, hepatic, renal, gastrointestinal or neoplastic disease;
- •4. acute medical conditions and/or conditions that could interfere with the study aims
- •5.relevant hepatopathy (ALT or AST > 100 U/l, gGT > 150 U/l, bilirubin > 1,5 mg/dl)
- •6. Relevant nephropathy (creatinine > 1.4 mg/dl)
- •7. low sodium levels (<130 mmol/l)
- •8 history of atrioventricular block and/or clinically relevant arrhythmia
- •9.intake of bezodiazepines on more than occasional basis
研究者
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