Safety and Effectiveness of Open-Label Clobazam in Subjects with Lennox Gastaut Syndrome

Ovation Pharmaceuticals0 个研究点目标入组 304 人开始时间: 2008年11月13日最近更新: 2012年9月25日

试验速览

暂无简介。

•1) The subject or subject's legally authorized representative must sign and date the
•Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
•Informed Consent Form (ICF)/Health Insurance Portability and Accountability Act
•(HIPAA) Authorization prior to study participation.
•2) Previous participation in an Ovation sponsored LGS study.
•Are the trial subjects under 18? yes
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Greater than 14 days have elapsed since the subject received his/her last dose of
•study medication in the previous Ovation-sponsored LGS study.
•Subject had a serious or severe adverse event in the previous Ovation sponsored
•LGS study that in the opinion of the investigator was probably or definitely related
•to clobazam use and precludes safe use of clobazam.
•Subject has had an anoxic episode requiring resuscitation within 1 year of study
•Subject has a history of an allergic reaction or significant sensitivity to
•benzodiazepines.
•Subject is taking more than 3 concurrent anti epileptic drugs (AEDs). NOTE: Vagal Nerve Stimulator (VNS) or ketogenic diet is allowed and will not be counted in the three allowed AEDs.
•Subject is currently taking long-term systemic steroids (excluding inhaled medication for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for idiopathic nephrotic syndrome or asthma.

发起方

Ovation Pharmaceuticals