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 个研究点开始时间: 2015年6月17日最近更新: 2017年10月2日

适应症

试验速览

暂无简介。

•- 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
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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.

发起方

TARGEO