NCT00504881已完成3 期
An International, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Study: Evaluation of the Safety and Efficacy of Brivaracetam in Subjects (≥ 16 to 70 Years Old) Suffering From Localization-related or Generalized Epilepsy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 480
- 主要终点
- Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period
研究概览
简要总结
This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects were aged from 16 to 70 years, inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
- •Subjects had well-characterized localization-related Epilepsy or generalized Epilepsy according to the International League Against Epilepsy (ILAE) classification
- •For subjects suffering from localization-related Epilepsy: subjects had at least 2 Partial-Onset Seizures (POSs) whether or not secondarily generalized per month during the 3 months preceding Visit 1 according to the ILAE classification
- •For subjects suffering from localization-related Epilepsy: subjects had at least 4 Partial-Onset Seizures (POSs) whether or not secondarily generalized during the 4-week Baseline Period according to the ILAE classification
- •For subjects suffering from generalized Epilepsy: subjects had at least 2 Type II-seizure days per month during the 3 months preceding Visit 1 according to the ILAE classification
- •For subjects suffering from generalized Epilepsy: subjects had at least 4 Type II-seizure days during the 4 week Baseline Period according to the ILAE classification
- •Subjects were uncontrolled while treated by 1 to 3 permitted concomitant Antiepileptic Drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED
排除标准
- •For subjects who suffered from localization-related Epilepsy: history or presence of Seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 2 or occurring only as Type IA non-motor
- •Subjects with a history or presence of Status Epilepticus during the year preceding Visit 1 or during Baseline
研究组 & 干预措施
Placebo
Placebo Comparator
Matching Placebo tablets administered twice a day
干预措施: Placebo (Drug)
Brivaracetam
Experimental
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
干预措施: Brivaracetam (Drug)
结局指标
主要结局
Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period
时间窗: Week 2 to the end of the Treatment Period (Week 16)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period
时间窗: Baseline (Week 0) to the end of the Treatment Period (Week 16)
Partial (Type I) seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to generalized tonic-clonic convulsions. Partial Onset Seizure (POS) frequency per week over the Treatment Period (TP) was calculated as: (Total Type I seizures over the TP)\*7/(Total number of days with no missing seizure count in the TP)
次要结局
- Time to Tenth Type I Seizure During Treatment Period(Baseline to 16-week Treatment Period)
- Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period(Baseline (Week 0) to the end of Treatment Period (Week 16))
- Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period(Baseline (Week 0) to the end of Treatment Period (Week 16))
- Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week(Baseline (Week 0) to end of Treatment Period (Week 16))
- Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period(Baseline to 16-week Treatment Period)
- Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period(Baseline (Week 0) to the end of Treatment Period (Week 16))
- Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 16-week Treatment Period(Baseline to 16-week Treatment Period)
- Time to First Type I Seizure During the 16-week Treatment Period(Baseline to 16-week Treatment Period)
- Time to Fifth Type I Seizure During the 16-week Treatment Period(Baseline to 16-week Treatment Period)
- Change From Baseline to the 16-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(Baseline to 16-week Treatment Period)
- Change From Baseline to the 16-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(Baseline to 16-week Treatment Period)
- Change From Baseline to the 16-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(Baseline to 16-week Treatment Period)
- Change From Baseline to the 16-week Treatment Period in Hospital Anxiety Score(Baseline to 16-week Treatment Period)
- Change From Baseline to the 16-week Treatment Period in Hospital Depression Score(Baseline to 16-week Treatment Period)
- Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit(Baseline to last visit or early discontinuation visit in the 16-week Treatment Period)
- Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit(Baseline to Last Visit or Early Discontinuation Visit in the 16-week Treatment Period)
- Change From Baseline to the 16-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(Baseline to 16-week Treatment Period)
- Change From Baseline to the 16-week Treatment Period in Emotional Well-being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(Baseline to 16-week Treatment Period)
- Change From Baseline to the 16-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(Baseline to 16-week Treatment Period)
- Change From Baseline to the 16-week Treatment Period in Overall Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(Baseline to 16-week Treatment Period)
- Change From Baseline to the 16-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score(Baseline to 16-week Treatment Period)
研究者
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