A Long term study of M071754 - A open-label study in patients with infantile spasms.

Alfresa Pharma Corporation and Sanofi KK0 个研究点目标入组 17 人开始时间: 2017年8月28日最近更新: 2017年9月4日

试验速览

暂无简介。

•Patients diagnosed with infantile spasms and who meet one of the following criteria
•- Patients who have completed the maintenance phase of the preceding phase III clinical study and have been confirmed efficacy and there is no safety concern
•- Patients who is taking Vigabatrin (in which case the frequency of spasms before the start of Vigabatrin and the cumulative dose of Vigabatrin must be confirmed)
•- Patients who has experience to take Vigabatrin (in which case the frequency of spasms before the start of Vigabatrin and the cumulative dose of Vigabatrin must be confirmed)
•- Patients who has no experience to take Vigabatrin
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 17
•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

•- Patients who is taking Vigabatrin more than maximum dose (150mg/kg/day or 3g/day)
•- Patients with concurrent severe liver/renal disease, cardiac disease, serious gastrointestinal disorder.
•- Patients who received adrenocorticotropic hormone (ACTH) products or steroids within 4 weeks (28 days) prior to the formal registration of this study.
•- Patients who have concurrent or a history of ophthalmological complication in whom possible aggravation of the symptoms with vigabatrin.
•- Patients with concomitant Lennox-Gastaut syndrome.

发起方

Alfresa Pharma Corporation and Sanofi KK