A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 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 200 人开始时间: 2015年7月10日最近更新: 2019年6月30日

研究概览

暂无简介。

•Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalized tonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981).
•Subject has =3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)
•If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures.
•Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed Anti-epileptic drugs (AEDs) OR 1 to 3 AEDs (with 1 AED identified as a benzodiazepine) for at least 28 days prior to Visit 1 with or without additional concurrent stable Vagus nerve stimulation (VNS).
•Subjects are required to have had an electroencephalogram (EEG) report consistent with IGE (eg, generalized =3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•History of partial onset seizures or EEG findings indicating partial onset seizures
•Symptomatic generalized epilepsy, e.g. Lennox-Gastaut Syndrome
•Lifetime history of suicide attempt, or suicidal ideation in past 6 months
•Women of child bearing potential must practice contraception according to protocol requirements
•Regular use of clozapine, monoamine oxidase A (MAO-A) inhibitors, barbiturates (for indication other than epilepsy) within 28 days prior to Visit 1
•Use of Felbamate or Vigabatrin within last 6 months
•Subject is on a ketogenic diet that has either changed within the 4 weeks prior to Visit 1 or is expected to change during the study.

发起方

CB BIOSCIENCES, Inc.