EUCTR2014-000360-17-FR
进行中（未招募）
1 期
Acceptability study of a new paediatric form of vigabatrin in infants and children with infantile spasms or pharmaco-resistant partial epilepsy.Observational, descriptive, open-label, multi-centric, non-randomized study - SOLUWEST
TARGEO0 个研究点2015年6月17日
适应症Infantile spasms and pharmaco-resistant partial epilepsyMedDRA version: 18.0Level: PTClassification code 10021750Term: Infantile spasmsSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 18.0Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Infantile spasms and pharmaco-resistant partial epilepsy
- 发起方
- TARGEO
- 状态
- 进行中（未招募）
- 最后更新
- 8年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Boys and girls.
- •\- Patients with diagnosed infantile spasms (IS) or pharmaco\-resistant partial onset seizures (POS).
- •\- Infants \> 1 month and \< 6 months; infants \> 6 months and \< 2 years; and children \> 2 years and \< 6 years.
- •\- Patients stabilized under Sabril® for at least 2 weeks prior to V1: patients with no spasms/POS or with a stable frequency of spasms/POS (i.e. with no more than 50% variation in the number of spasms/POS) within 2 weeks prior to V1\.
- •\- Patients under a twice\-a\-day posology of Sabril®.
- •\- Subjects covered by or having the rights to social security.
- •\- Signed informed consent and/or child assent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1\.2 Adults (18\-64 years) no
排除标准
- •\- Change in anti\-epileptic treatment and/or Sabril® dose within 7 days before V1\.
- •\- 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 \< 4 Kgs.
- •\- Any planned major surgery within the duration of the trial.
- •\- Participation in any other clinical trial within 3 months prior to V1\.
- •\- Lack of ability or willingness to give informed consent.
- •\- Anticipated non\-availability for study visits / procedures.
- •\- Lack of willingness or inability to co\-operate adequately.
结局指标
主要结局
未指定
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