A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093 in Controlling Refractory Partial Seizures When Added to Ongoing Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- The Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as "Responders") in a Treatment Period Compared to the Baseline Period
研究概览
简要总结
The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of epileptic patients with refractory simple or complex partial seizures with or without secondary generalization.
详细描述
This clinical trial was performed as a multicentre, add-on, double-blind, randomised, placebo-controlled, phase II study. During the double-blind treatment phase (12 weeks) patients were assigned to three treatment groups receiving BIA 2 093 once daily (ODG - once-daily group), BIA 2 093 twice daily (TDG - twice-daily group) or placebo (PLG - placebo group), respectively. Daily doses of BIA 2 093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
On completion of the 12-week double-blind treatment period, a 1-week tapering period was scheduled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18-65 years
- •Patients with simple or complex partial seizures with or without secondary generalization since at least one year prior to randomisation visit
- •At least 4 seizures per month within the last 2 months prior to randomisation
- •Stable dose regimen of a maximum of two of the following AEDs: phenytoin, valproate, primidone, phenobarbital, lamotrigine, gabapentin, topiramate, clonazepam, during 2 months prior to randomisation
- •Electroencephalogram (EEG) findings not contradicting the epilepsy diagnosis (e.g., primarily generalized epilepsy)
- •Written informed consent.
排除标准
- •Patient with nervus vagus stimulation
- •Patient with primarily generalized seizures
- •Known progressive neurological disturbance
- •A history of status epilepticus within the past 3 months
- •Seizure of non-epileptic origin
- •Restricted legal competence and incapability to follow trial instructions
- •Major psychiatric disorders
- •Concurrent drug therapy with monoamine oxidase inhibitors or calcium channel blockers
- •Need of excluded concomitant medication (see section 9.4.6.2)
- •Use of oxcarbazepine or carbamazepine during the last 6 months before the randomisation visit
- •Known hypersensitivity to oxcarbazepine or carbamazepine, or its metabolites
- •Abuse of alcohol, drugs or medications
- •History of relevant cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, hematologic or oncology disorders
- •Second- or third-degree atrioventricular block not corrected with a pacemaker
- •Relevant laboratory abnormalities (e.g., Na+< 130 mmol/L, alanine (ALT) or aspartate (AST) transaminase >2.0 times the upper limit of normal, white blood cell (WBC) count <3000 cells/mm3)
- •Pregnancy, nursing or inadequate contraception in women of childbearing age (oral contraception should be combined with a barrier method)
- •Participation in other clinical trials within the last 2 months
- •History of non-compliance.
研究组 & 干预措施
ODG - once-daily group
BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
干预措施: BIA 2-093 (Drug)
TDG - twice-daily group
BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).
干预措施: BIA 2-093 (Drug)
PLG - placebo group
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as "Responders") in a Treatment Period Compared to the Baseline Period
时间窗: baseline, week 12
次要结局
未报告次要终点