An Open-Label Pilot Study to Assess the Safety of Oral Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy

CB BIOSCIENCES, Inc.0 个研究点目标入组 45 人开始时间: 2015年3月10日最近更新: 2015年3月16日

适应症

试验速览

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•- Subject has a diagnosis of uncontrolled epilepsy with Primary generalized tonic-clonic (PGTC) seizures and idiopathic generalized epilepsy. Diagnosis should have been established by an electroencephalogram (EEG) with generalized spike-wave discharges within 5 years of the screening visit
•- Subject has =1 PGTC seizure within the 12 weeks prior to the screening visit
•- Subject has a stable dose regimen of 1 to 3 marketed antiepileptic drug(s) (AEDs) with or without additional concurrent stable Vagus Nerve Stimulation (VNS). The VNS must have been in place for at least 6 months prior to study entry with constant settings for at least 28 days prior to the screening visit and during the Baseline Phase. Benzodiazepines will be counted as an AED
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 5
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- Subject has a history of partial-onset seizures or EEG findings consistent with partial onset seizures
•- Subject has a history of status epilepticus within the 5-year Period prior to Visit 1
•- Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events
•- Subject has any medical or psychiatric condition
•- Subject has any history of alcohol or drug abuse
•- Subject is currently taking felbamate
•- Subject has ever taken vigabatrin and has no visual fields examination report available or if results of the examination are abnormal
•- Subject is on a ketogenic diet
•- Subject has a known sodium channelopathy

发起方

CB BIOSCIENCES, Inc.