Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy. Observational, Descriptive, Open-label, Multi-centric, Non-randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 23
- 主要终点
- Individual adherence to the new Soluble Tablets (ST) formulation of Vigabatrin (VGB) using Medication Event Monitoring System (MEMS)
研究概览
简要总结
The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6 years) and 500 mg granules for oral solution sachets (for infants and children below 6 years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often required.
This study is a descriptive, non-randomized, open label multi-centric acceptability study in infants and children affected with infantile spasms. The primary objective is to describe the adherence to the new formulation. Secondary objectives include:
- evaluation of the palatability and user-friendliness of the new treatment,
- evaluation of the pharmacokinetic parameters of the new formulation,
- PK parameters,
- evaluation of the tolerance,
- measurement of taurine plasma levels. This study will recruit up to 40 patients with infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23 clinical sites in France.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosed infantile spasms (IS) or pharmacoresistant partial onset seizures (POS).
- •Infants > 1 month and < 6 months; infants > 6 months and < 2 years; and children > 2 years and < 6 years.
- •Patients under Sabril® or naive patients.
- •Patients under a twice-a-day posology of Sabril® or patients for whom vigabatrin will be given twice daily.
- •Non inclusion Criteria:
- •Use of more than 2 other antiepileptic drugs as concomitant treatment (including steroids). Ketogenic diet can be in addition to these 2 other antiepileptic drugs.
- •Subjects receiving vigabatrin through a gastric tube.
- •Weight < 1.750 Kgs.
- •Any planned major surgery within the duration of the trial.
- •Participation in any other clinical trial within 3 months prior to V1.
排除标准
- 未提供
研究组 & 干预措施
Vigabatrin: Vigabatrin new ST formulation then Sabril®
Sabril®: sachet for oral solution 500 mg, 50 to 100mg/Kg/day, twice a day, 14 days.
Vigabatrin new ST formulation: Soluble tablets 100 or 500 mg, 50 to 100mg/Kg/day, twice a day, 12 weeks.
干预措施: Vigabatrin: Vigabatrin new ST formulation then Sabril® (Drug)
结局指标
主要结局
Individual adherence to the new Soluble Tablets (ST) formulation of Vigabatrin (VGB) using Medication Event Monitoring System (MEMS)
时间窗: from V1 (day 1) to V3 (day 84), continuous assessment.
Adherence will be assessed by measurement of the dosing history of patients using an electronic Medication Event Monitoring System (MEMS).The date and time of each opening will be recorded
次要结局
- Safety and tolerance(Results of electroretinogram: when available from D1 to D126; Blood assessment: at D1 & D84; Vital signs at D1, D28, D84, D98 & D126; Adverse events, serious adverse events: evaluated for the duration of study participation (at D1, D28, D84, D98 & D126))
- pharmacokinetic parameters for the new ST formulation (1 sample). Pharmacokinetic parameters for the new ST formulation (population PK) : Area under the curve (AUC), Tmax, Cmax, T½, Ka, V/F, Cl/F(PK D84: 1 sample before treatment.)
- palatability of the new ST formulation and of Sabril® "granules for oral solution".(during 7 consecutive days: from D90 to D96 under Sabril® and from D29 to D35 under the new ST formulation)
- Ease of use of the new ST formulation and of Sabril® "granules for oral solution".(during 7 consecutive days: from D90 to D96 under Sabril® and from D29 to D35 under the new ST formulation.)
- Evaluation of the taurine plasma levels in children treated by vigabatrin. Taurine plasma concentration will be measured and a relationship between vigabatrin exposition and taurine plasma levels will be sought.(1 sample will be drawn at V3 (day 84): just before treatment when patient is fasting.)
- Adherence to the new ST formulation and to Sabril® granules for oral solution, by treatment unit accountability(VGB-ST: V1 (day 1) to V3 (day 84). Sabril®:V3 (day 85) to V4 (day 98))