NCT00385411已完成4 期
Therapeutic Follow-up Observational Study and Population Kinetics Ancillary Study of Valproate Microgranules (Micropakine® SR) in Patients Aged Between 6 Months and 15 Years Suffering From Epilepsy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Clinical and biological safety.
研究概览
简要总结
Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of valproate administered as microgranules, under standard prescription conditions, with therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations and antiepileptic comedication as well as biological assays.
Secondary objectives: Ancillary population kinetics study
- Estimate the pharmacokinetic parameters of valproate administered as microgranules under standard therapeutic conditions within the population studied, from the therapeutic follow-up data.
- Evaluate the influence of individual characteristics on the pharmacokinetic parameters.
- Describe the relationship between plasma concentrations and adverse events for valproate and the main anti-epileptic comedications.
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
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 6 months and 15 years.
- •Suffering from any type of epilepsy.
- •Receiving at the time of inclusion valproate in the form Micropakine® SR 20 to 30 mg/kg/d by oral route, in 2 daily administrations and at most two other antiepileptic drugs (an antiepileptic benzodiazepine treatment taken daily or on demand more than 2 times weekly, must be considered as an antiepileptic treatment).
- •Followed by hospital paediatricians or neuropaediatricians.
- •For whom the consent has been signed by the parents or the holders of parental authority and if possible by the child him/herself.
- •For whom the parents or legal guardian do not have any language or cultural obstacle for understanding the study.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
研究组 & 干预措施
valproate
Experimental
干预措施: valproate microgranules (Drug)
结局指标
主要结局
Clinical and biological safety.
时间窗: at each visit
Pharmacokinetic parameters and covariables likely to explain the variability in the pharmacokinetic parameters of valproate
时间窗: Ancillary population kinetics study
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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