NCT00102713已完成3 期
An Open Label Study for Treatment of Partial Seizures in Children
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 50
- 试验地点
- 16
- 主要终点
- Partial Seizure Rate at Week 4
研究概览
简要总结
The purpose of the study is to assess the safety profile of the investigational medication, Depakote Sprinkle Capsules, in the treatment of partial seizures in children ages 3-10.
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
- 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 3:
- •EEG at some time in past demonstrating focal abnormalities consistent with partial seizures
- •If the EEG is inconclusive or does not support partial seizures, then an MRI/CT will be done
- •If the MRI/CT fails to support a diagnosis of partial seizures, the subject may still qualify based on the principal Investigator's clinical diagnosis
- •Subject weighs at least 15 kg (33 lbs).
- •Parent/caregiver is able to keep an accurate seizure diary.
排除标准
- •Has had status epilepticus in the past 3 months prior to Screening
- •Has a history of any of: 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
- •Receiving systemic chemotherapy
- •Requires treatment with aspirin
- •Subject is pregnant
- •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
Partial Seizure Rate at Week 4
次要结局
- WASI
- UKU-Neurologic Assessment
- ECG
- Vital Signs
- PK analysis
- WPPSI-III
- BASC
- Adverse Events
- Clinical Laboratory Assessments
研究者
研究点 (16)
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