EUCTR2011-003100-21-Outside-EU/EEA进行中（未招募）1 期
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 242 人开始时间: 2021年11月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 242
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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) with no benzodiazepine AEDs OR 1 benzodiazepine marketed AED with 1 to 2 non-benzodiazepine marketed AEDs 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: 60
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM)
- •Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
- •Subject has >=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%).
- •History of partial onset seizures or EEG findings indicating partial onset seizures
- •Symptomatic generalized epilepsy, (eg, Lennox-Gastaut Syndrome
- •typically presenting with seizures including tonic seizures), some other related syndrome like Doose’s syndrome (typically presenting with myoclonic-atonic seizures) or evidence of both focal and generalized epilepsy.
- •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.
研究者
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