A Multicenter, Double Blind, Randomized, Placebo-Controlled Trial toDetermine the Efficacy and Safety of Ganaxolone as Adjunctive Therapy for Adults with Drug-Resistant Partial-Onset Seizures Followed by Long-term Open-Label Treatment

Marinus Pharmaceuticals, Inc0 个研究点目标入组 342 人开始时间: 2015年1月7日最近更新: 2019年6月30日

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•Male and female subjects 18 years of age and older able to provide written informed consent with a confident diagnosis of epilepsy with POS with or without secondary generalization with a POS frequency rate of =3 POS per 28-day who are currently treated on a stable regimen of AEDs.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 42

•Subjects must not have previous exposure to ganaxolone, generalized epilepsy, have less than 3 POS seizures per 28-day period or =21 seizure-free days. Subject should not have innumerable seizures, more than 100 POS total per each 4-week baseline period. No subjects will be admitted who have an active central nervous system (CNS) infection, demyelinating disease, degenerative neurological disease, CNS disease deemed progressive, clinically unstable psychiatric disorder, suicide attempt within the last 5 years, or current significant suicidal ideation.

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