NCT00067431终止3 期
A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children
Abbott7 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2003年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- Change from baseline in the 4-week partial seizure rate
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of two concentration ranges of valproate using Depakote Sprinkle Capsules as adjunctive therapy in the treatment of partial seizures, with or without secondary generalization, in children 3-10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has diagnosis of partial seizures with/without secondary generalization, supported by:
- •Observed ictal events consistent with partial seizures: With/ without secondary generalization; Documented by reliable observers
- •1 of following 2: EEG at some time in past demonstrating focal abnormalities consistent with partial seizures; OR, in absence of demonstrable EEG abnormality: MRI/CT scan evidence of a focal CNS lesion consistent with partial seizures
- •On stable dose of 1 or 2 antiepileptic drug(s) (AED) other than valproate, for at least 1 month
- •Not taking valproate or is currently receiving valproate resulting in a trough concentration of less than 40 mcg/mL
- •History of at least 4 partial seizures/month in 2 months prior to screening
- •Parent/caregiver is able to keep an accurate seizure diary
排除标准
- •History of any of following: Lennox-Gastaut syndrome; Primary generalized seizures; Infantile spasms; Mixed seizure disorders including atypical absence; Myoclonic or atonic seizures; Pseudoseizures or Epilepsia Partialis Continuans (EPC)
- •Has had status epilepticus in the past 6 months
- •Has significant history of any of following that would confound study results: Cardiac (including clinically important abnormality on ECG); Renal; Psychiatric (including psychosurgery); Oncologic; Endocrine; Metabolic; Pancreatic; Hepatic disease (including clinical/serological history of hepatitis); Urea cycle disorder
- •Has: Expanding CNS neoplasm; Active CNS infection; Demyelinating disease; Degenerative neurological disease; Progressive encephalopathy; or any Progressive CNS disease
- •Has platelet count less than or equal to 100,000/mcL
- •Has blood chemistry ALT/AST value(s) greater than or equal to 2 times upper limit of normal at screening
- •Requires anticoagulant drug therapy
- •Not expected to be able to maintain same dose of all pre-study AEDs, excluding valproate, throughout study
- •Receiving systemic chemotherapy
- •Has taken lamotrigine, felbamate, or pemoline, within past 3 months prior to screening
- •Has been on ketogenic diet within 30 days prior to screening
- •Considered by investigator to be non-responder to valproate for treatment of epilepsy (e.g., Despite adequate trial with serum concentrations of 60 mcg/mL or greater, subject continues to have inadequate seizure control)
结局指标
主要结局
Change from baseline in the 4-week partial seizure rate
次要结局
- Adverse events
- Laboratory data
- Vital signs
研究者
研究点 (7)
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