A controlled double-blind crossover trial of ganaxolone in children with fragile X syndrome - GNX study

Antwerp University Hospital0 个研究点目标入组 60 人开始时间: 2014年8月18日最近更新: 2015年12月14日

适应症

试验速览

暂无简介。

•1.Molecular documentation of the FMR1 full mutation.
•2.Ages 6 through 17 years, inclusive.
•3.Willingness of parent or caretaker to participate in the protocol.
•4.Sexually active women of child bearing potential must be using a medically acceptable method of birth control and have a negative qualitative serum ß-human chorionic growth hormone (ß-HCG) or urine pregnancy test collected at the initial screening visit.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•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

•1.Persons who do not speak English or Dutch.
•2.Concomitant medications including systemic steroids, Vigabatrin, felbamate, and ketoconazole.
•3.Changes in any medications within the last two months.
•4.Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin level abnormalities.
•5.History of recurrent status epilepticus.
•6.Have been exposed to any other investigational drug within 30 days or less than 6 half-lives prior to randomization.
•7.Subjects who are actively suicidal or have an active and compromising (CNS) disease.

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