NCT00855738已完成4 期
Liceo Study: A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点目标入组 111 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 主要终点
- Percent of Participants Classified as Responders
研究概览
简要总结
Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate, used as first-choice combination therapy (bitherapy) in patients with focal epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Diagnosis of focal epilepsy.
- •Previous failure of one or more AEDs used in monotherapy.
- •Background treatment with an antiepileptic drug.
- •The investigator has considered that the patient must start treatment with some of the seven new AEDs in combination therapy: lamotrigine, levetiracetam, gabapentin, oxcarbazepine, pregabalin, tiagabine and/or topiramate.
- •History of seizures in the patient in the past 3 months.
- •The patient or legal guardian must be able to understand the characteristics of the study and fill in the seizure diaries.
- •Written informed consent.
排除标准
- •Inability to comply with the study requirements.
- •Diagnosis of generalized epilepsy or inability to establish if focal or generalized.
- •Presence of serious or uncontrolled systemic disease, serious psychiatric disease or progressive neurological disease.
- •History of alcoholism, drug addiction, or abuse of medicines in the past two years.
- •Psychogenic seizures in the two years prior to inclusion in the study.
研究组 & 干预措施
1.0
Other
干预措施: Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide (Drug)
结局指标
主要结局
Percent of Participants Classified as Responders
时间窗: Baseline, Month 3, Month 6 (last 3 months of treatment)
Responder = decrease in number of seizures by \>=50 percent (%) during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the number of seizures that occurred during the 3 months before the baseline visit (baseline).
次要结局
- Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment(Baseline, Month 3, Month 6 (last 3 months of treatment))
- Time to Discontinuation Due to Safety, Tolerability, or Treatment Compliance(Baseline, Month 3, Month 6)
- Percent of Days Without Crisis During the Study(Baseline through Month 6 (or end of treatment))
- Time to Discontinuation Due to Lack of Efficacy(Baseline, Month 3, Month 6)
- Time to First Seizure(Baseline to Month 6 (or end of treatment))
- Percent of Participants Who Continued on Study Medication to Month 6(Baseline to Month 6)
- Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS)(Baseline to Month 6)
- Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy(Baseline to Month 6)
- Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation(Baseline, Month 3, Month 6 (last 3 months of treatment))
- Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment(Baseline, Month 3, Month 6 (last 3 months of treatment))
- Time to Discontinuation Due to Other Reasons(Baseline, Month 3, Month 6)
- Treatment Satisfaction Evaluated by Patient Global Impression of Change Visual Analog Scale (VAS)(Baseline, Month 3, Month 6)
- Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10)(Baseline to Month 6)
- Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS)(Baseline, Month 3, Month 6)
- Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit(Month 6)
- Percent of Participants Reaching Monotherapy(Baseline through Month 6 (or end of study))
- Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED)(Baseline to Month 6 (or end of treatment))
- Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy(Baseline through Month 6 (or end of treatment))
- Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)(Baseline to Month 6)
- Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy(Baseline to Month 6)
- Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS)(Baseline, Month 6)
研究者
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